Diabetic Neuropathy
Conditions
Keywords
diabetes mellitus, diabetic neuropathies, Aerobic Exercise, Exercise Therapy, electromyography, United States Veterans
Brief summary
This study will determine the type and combination of exercise needed to rehabilitate the neuro-compromised diabetic Veteran. Guided exercise protocols may prove to be practical therapeutic options for the prophylactic management of diabetic subjects with neuropathy.
Detailed description
Purpose: A single-site, randomized, blinded, prospective clinical trial is proposed to determine the significance of a combined isokinetic strength and aerobic exercise training program on the rehabilitation of peripheral nerve function in Type 2 diabetic veterans and non-veterans with neuropathy. Background and Significance: Obesity is a major factor in the increasing rates of diabetes and its related complications. Diabetes affects greater than 7% of the population. Veterans are at even greater risk, with approximately 16% currently receiving treatment at Department of Veterans Affairs Medical Centers for diabetes. More than half of affected veterans experience debilitating complications of diabetes, including peripheral neuropathy (PN). Exercise training, in combination with pharmacologic intervention, is now recognized as a cornerstone of management for diabetes. Therapeutic interventions currently available for the treatment of PN in diabetic patients are limited, however, to pain management and stringent glycemic control. Exercise is reported to significantly decrease peripheral nerve microvascular complications common among chronic diabetics. Our preliminary findings demonstrate that exercise intervention improves peripheral nerve function in the diabetic veteran with PN. Intervention strategies, such as proposed in this application, offer a unique and novel therapeutic option for the rehabilitation of the neuro-compromised Type 2 diabetic veterans and non-veterans. Methods & Research Plan: One-hundred subjects will be recruited for this 24-week study. Subjects each will be randomly assigned to aerobic, isokinetic strength training, combined aerobic and strength training, or non-exercise (control) intervention groups. Isokinetic strength training (Biodex System 3), aerobic exercise training (treadmill), or the combination of strength and aerobic training will be administered 3x per week for the initial 12 weeks. Control subjects will receive 12 clinical visits over the course of the initial 12 weeks. The effects of exercise training type, compared with control subjects, on recovery of peripheral nerve function will be rigorously determined from baseline, 12- and 24-week testing using electrodiagnostic primary outcome measures, Quantitative Sensory Testing, and a battery of validated qualitative and quantitative secondary outcome measures that include an incremental symptom-limited treadmill test, peak torque, Total Neuropathy Score, visual analogue pain scale, and quality of life SF-36V Health Survey. Sustainability of effect will be determined at 24-weeks.The individual effects of exercise training type, compared with control subjects, on tissue oxygenation will be determined from baseline, 12- and 24-week testing by non-invasive quantitated infrared spectroscopy using an InSpectraTM Tissue Spectrometer. Expected Outcomes: This study will objectively and critically determine the type and combination of exercise needed to rehabilitate the neuro-compromised diabetic Veteran. Guided exercise protocols may prove to be practical therapeutic options for the prophylactic management of diabetic subjects with neuropathy.
Interventions
BEHAVIORALExercise
Structured aerobic exercise (treadmill).
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of type 2 diabetes mellitus * stable blood glucose control * clinical findings consistent with length-dependent sensorimotor polyneuropathy, stage N2a
Exclusion criteria
* foot ulceration * unstable heart disease * co-morbid conditions limiting exercise * disorders of the central nervous system causing weakness or sensory loss * received treatment with medications known to have neuropathy as a prominent side effect including vincristine, vinblastine, cis-platin, and paclitaxel * medical conditions that may be associated with neuropathies such as alcoholism, liver disease, kidney disease, toxic exposure, vitamin deficiency, autoimmune disorders, cancer, or hypothyroidism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensory Ulnar Nerve Conduction Velocity | Baseline, 12 wks, 24 wks | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Sensory Ulnar Nerve Latency | Baseline, 12 wks, 24 wks | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Sensory Ulnar Nerve Amplitude | Baseline, 12 wks, 24 wks | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Sensory Median Nerve Conduction Velocity | Baseline, 12 wks, 24 wks | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Tibial Nerve Amplitude | Baseline, 12 weeks, 24 weeks | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Sensory Median Nerve Latency | Baseline, 12wks, 24 wks | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Sensory Median Nerve Amplitude | Baseline, 12, and 24 weeks | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Tibial Nerve Conduction Velocity | Baseline, 12 weeks, 24 weeks | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Sural Nerve Amplitude | Baseline, 12, and 24 weeks | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Sural Nerve Latency | Baseline, 12 wks, 24 wks | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Sural Nerve Conduction Velocity | Baseline, 12 wks, 24 wks | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Tibial Nerve Latency | Baseline, 12 weeks, 24 weeks | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Peroneal Nerve Conduction Velocity | Baseline, 12 wks, 24 wks | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Peroneal Nerve Latency | Baseline, 12 wks, 24 wks | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Peroneal Nerve Amplitude | Baseline, 12 wks, 24 wks | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Respiratory Exchange Ratio (RER) During TMT | Baseline, 12-wks, 24-wks | Peak RER achieved while undergoing a modified Bruce Protocol treadmill test (TMT). This is a mathematical ratio of maximally achieved (peak) VCO2 divided by maximally achieved (peak) VO2. |
| Symptom-Limited TMT Maximum Minute Ventilation (VE) | Baseline, 12-wks, 24-wks | Peak volume of air exchanged per minute achieved while undergoing a modified Bruce Protocol treadmill test (TMT) |
| Symptom-Limited TMT Blood Glucose Response | Initial entry into study, 12 and 24 weeks | Changes in blood glucose in response to modified Bruce Protocol treadmill test (TMT) |
| Short Form-36V: Physical Component Score | Initial entry into study, 12 and 24 weeks | The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Physical Component scores reflect perceived changes in physical health relative to the previous year. |
| Voluntary Duration of Symptom-Limited TMT | baseline, 12-wks, 24-wks | Total time subjects voluntarily exercised while undergoing a modified Bruce Protocol treadmill test (TMT) |
| Symptom-Limited TMT Maximum Heart Rate | baseline, 12-wks, 24-wks | Peak heart rate achieved while undergoing a modified Bruce Protocol treadmill test (TMT) |
| Symptom-Limited TMT Maximum Systolic Blood Pressure | Baseline, 12-wk, 24-wk | Peak systolic BP achieved while undergoing a modified Bruce Protocol treadmill test (TMT) |
| Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | Baseline, 12-wks, 24-wks | Peak Oxygen uptake achieved while undergoing a modified Bruce Protocol treadmill test (TMT) |
| Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | Baseline, 12-wks, 24-wks | Peak Carbon Dioxide expelled achieved while undergoing a modified Bruce Protocol treadmill test (TMT) |
| Symptom-Limited TMT Maximum METS Achieved (MET) | Baseline, 12-wks, 24-wks | Peak metabolic rate equivalents (METS) achieved while undergoing a modified Bruce Protocol treadmill test (TMT). One MET is defined as the metabolic rate observed at rest, quantified as resting oxygen consumption of 250 ml/min (Male) or 200 ml /min (female). A value of 5 METS would represent a metabolic rate that is 5x that at rest and is considered an indicator of how hard a given individual is exercising. Data shown are expressed as a ratio at peak of exercise of oxygen consumed relative to normalized values for men or women at rest. |
| Short Form-36V: Mental Component Score | initial entry into study, and at 12-wks and 24-wks | The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Mental Component scores reflect perceived changes in emotional health relative to the previous year. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Height | baseline | Height of subjects upon entry into study |
| Age | at baseline | Age of participants at entry into study. |
| Thyroid Stimulating Hormone Laboratory Values | Baseline | Laboratory values for Thyroid Stimulating Hormone (TSH) at baseline entry into study |
| Aspartate Aminotransferase Laboratory Values | Baseline | Laboratory values for Aspartate Aminotransferase (AST) at baseline entry into study |
| Blood Urea Nitrogen (BUN) Laboratory Values | Baseline | Laboratory Blood Urea Nitrogen levels at baseline entry into study |
| Creatinine Laboratory Values | Baseline | Laboratory creatinine values at baseline entry into study |
| Cholesterol Laboratory Values | Baseline | Laboratory total cholesterol, HDL-cholesterol, and LDL-cholesterol levels at baseline entry into study |
| Triglyceride Laboratory Values | Baseline | Laboratory triglyceride values at baseline entry into study |
| HbA1C Laboratory Values | Baseline, 12-wk, 24-wk | Laboratory values of subject HbA1C levels at Baseline, 12-wk, 24-wk |
| Duration of Diabetes Mellitus | Baseline | Duration, in years, since first diagnosed with Diabetes Mellitus upon entry into study |
| Body Mass Index (BMI) | Baseline, 12-wk, 24-wk | BMI is calculated as a ratio of subject body mass (kg) divided by the square of subject height (m). |
| Weight | Baseline, 12-wks, 24-wks | Weight of subjects at baseline, 12-weeks, and 24-weeks |
Countries
United States
Participant flow
Recruitment details
Edward Hines Jr. VA Hospital from January 2010-May 2014.
Pre-assignment details
Prior to group randomization, all consenting subjects underwent two separate symptom-limited treadmill stress tests to unmask potentially life-threatening indolent cardiac and/or respiratory disease limitations
Participants by arm
| Arm | Count |
|---|---|
| Sedentary Sedentary Control Group | 12 |
| Aerobic Exercise Structured aerobic exercise (treadmill). | 11 |
| Strength Exercise Structured isokinetic strength exercise (dynameter). | 11 |
| Combined Aerobic and Strength Structured aerobic exercise (treadmill).plus structured isokinetic strength exercise (dynameter). | 11 |
| Total | 45 |
Baseline characteristics
| Characteristic | Sedentary | Aerobic Exercise | Strength Exercise | Combined Aerobic and Strength | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61.0 years STANDARD_DEVIATION 7 | 61.9 years STANDARD_DEVIATION 8.3 | 64.2 years STANDARD_DEVIATION 9.5 | 63.0 years STANDARD_DEVIATION 6.6 | 62.5 years STANDARD_DEVIATION 1.4 |
| Race/Ethnicity, Customized African American | 6 Participants | 3 Participants | 4 Participants | 3 Participants | 16 Participants |
| Race/Ethnicity, Customized Caucasian | 6 Participants | 7 Participants | 6 Participants | 7 Participants | 26 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 12 Count of Participants | 11 Count of Participants | 11 Count of Participants | 11 Count of Participants | 45 Count of Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 11 Participants | 10 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 12 | 4 / 11 | 4 / 11 | 5 / 11 |
| other Total, other adverse events | 0 / 12 | 0 / 11 | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 6 / 12 | 4 / 11 | 4 / 11 | 5 / 11 |
Outcome results
Primary
Peroneal Nerve Amplitude
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 wks, 24 wks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Peroneal Nerve Amplitude | Baseline | 2.16 mV | Standard Deviation 2.17 |
| Sedentary Control Group | Peroneal Nerve Amplitude | 24 weeks | 2.45 mV | Standard Deviation 2.72 |
| Sedentary Control Group | Peroneal Nerve Amplitude | 12 weeks | 1.89 mV | Standard Deviation 2.27 |
| Aerobic Exercise Group | Peroneal Nerve Amplitude | Baseline | 2.33 mV | Standard Deviation 2.01 |
| Aerobic Exercise Group | Peroneal Nerve Amplitude | 24 weeks | 1.70 mV | Standard Deviation 1.51 |
| Aerobic Exercise Group | Peroneal Nerve Amplitude | 12 weeks | 1.55 mV | Standard Deviation 1.51 |
| Strength Exercise Group | Peroneal Nerve Amplitude | 12 weeks | 1.43 mV | Standard Deviation 1.35 |
| Strength Exercise Group | Peroneal Nerve Amplitude | Baseline | 1.89 mV | Standard Deviation 1.68 |
| Strength Exercise Group | Peroneal Nerve Amplitude | 24 weeks | 1.75 mV | Standard Deviation 1.73 |
| Combined Aerobic and Strength Exercise Group | Peroneal Nerve Amplitude | Baseline | 2.79 mV | Standard Deviation 1.91 |
| Combined Aerobic and Strength Exercise Group | Peroneal Nerve Amplitude | 24 weeks | 2.71 mV | Standard Deviation 1.97 |
| Combined Aerobic and Strength Exercise Group | Peroneal Nerve Amplitude | 12 weeks | 2.52 mV | Standard Deviation 1.47 |
Comparison: Evaluated within group across time.p-value: 0.96ANOVA
Comparison: Evaluated within group across time.p-value: 0.53ANOVA
Comparison: Evaluated within group across time.p-value: 0.79ANOVA
Comparison: Evaluated within group across time.p-value: 0.94ANOVA
Comparison: Comparison across groups at baselinep-value: 0.75ANOVA
Comparison: Comparison across groups at 12-wksp-value: 0.51ANOVA
Comparison: Comparison across groups at 24-wks.p-value: 0.63ANOVA
Primary
Peroneal Nerve Conduction Velocity
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 wks, 24 wks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. No data recorded for 1 Sedentary subject at 3 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Peroneal Nerve Conduction Velocity | 24 weeks | 29.41 m/s | Standard Deviation 17.28 |
| Sedentary Control Group | Peroneal Nerve Conduction Velocity | Baseline | 30.58 m/s | Standard Deviation 14.92 |
| Sedentary Control Group | Peroneal Nerve Conduction Velocity | 12 weeks | 29.07 m/s | Standard Deviation 16.98 |
| Aerobic Exercise Group | Peroneal Nerve Conduction Velocity | 12 weeks | 32.56 m/s | Standard Deviation 11.15 |
| Aerobic Exercise Group | Peroneal Nerve Conduction Velocity | Baseline | 32.01 m/s | Standard Deviation 11.82 |
| Aerobic Exercise Group | Peroneal Nerve Conduction Velocity | 24 weeks | 33.40 m/s | Standard Deviation 11.56 |
| Strength Exercise Group | Peroneal Nerve Conduction Velocity | 12 weeks | 29.46 m/s | Standard Deviation 16.19 |
| Strength Exercise Group | Peroneal Nerve Conduction Velocity | Baseline | 32.97 m/s | Standard Deviation 13.59 |
| Strength Exercise Group | Peroneal Nerve Conduction Velocity | 24 weeks | 31.06 m/s | Standard Deviation 12.27 |
| Combined Aerobic and Strength Exercise Group | Peroneal Nerve Conduction Velocity | Baseline | 33.33 m/s | Standard Deviation 11.82 |
| Combined Aerobic and Strength Exercise Group | Peroneal Nerve Conduction Velocity | 24 weeks | 33.08 m/s | Standard Deviation 13.69 |
| Combined Aerobic and Strength Exercise Group | Peroneal Nerve Conduction Velocity | 12 weeks | 33.86 m/s | Standard Deviation 13.28 |
Comparison: Evaluate within group across time.p-value: 0.98ANOVA
Comparison: Evaluate within group across time.p-value: 0.99ANOVA
Comparison: Evaluate within group across time.p-value: 0.84ANOVA
Comparison: Evaluate within group across time.p-value: 1ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.96ANOVA
Comparison: Comparison across groups at 12-wks.p-value: 0.86ANOVA
Comparison: Comparison across groups at 24-wks.p-value: 0.92ANOVA
Primary
Peroneal Nerve Latency
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 wks, 24 wks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Peroneal Nerve Latency | 24 weeks | 4.69 ms | Standard Deviation 3.1 |
| Sedentary Control Group | Peroneal Nerve Latency | Baseline | 4.69 ms | Standard Deviation 2.58 |
| Sedentary Control Group | Peroneal Nerve Latency | 12 weeks | 4.49 ms | Standard Deviation 2.72 |
| Aerobic Exercise Group | Peroneal Nerve Latency | Baseline | 4.93 ms | Standard Deviation 1.95 |
| Aerobic Exercise Group | Peroneal Nerve Latency | 24 weeks | 4.63 ms | Standard Deviation 1.65 |
| Aerobic Exercise Group | Peroneal Nerve Latency | 12 weeks | 4.85 ms | Standard Deviation 1.72 |
| Strength Exercise Group | Peroneal Nerve Latency | 12 weeks | 4.52 ms | Standard Deviation 2.46 |
| Strength Exercise Group | Peroneal Nerve Latency | Baseline | 4.96 ms | Standard Deviation 1.88 |
| Strength Exercise Group | Peroneal Nerve Latency | 24 weeks | 5.28 ms | Standard Deviation 2.14 |
| Combined Aerobic and Strength Exercise Group | Peroneal Nerve Latency | Baseline | 4.65 ms | Standard Deviation 1.88 |
| Combined Aerobic and Strength Exercise Group | Peroneal Nerve Latency | 24 weeks | 4.68 ms | Standard Deviation 2.2 |
| Combined Aerobic and Strength Exercise Group | Peroneal Nerve Latency | 12 weeks | 5.06 ms | Standard Deviation 2.17 |
Comparison: Evaluated within group across time.p-value: 0.98ANOVA
Comparison: Evaluated within group across time.p-value: 0.99ANOVA
Comparison: Evaluated within group across time.p-value: 0.89ANOVA
Comparison: Evaluate within group across time.p-value: 0.9ANOVA
Comparison: Comparison across groups at baselinep-value: 0.98ANOVA
Comparison: Comparison across groups at 12-wksp-value: 0.94ANOVA
Comparison: Comparison across groups at 24-wks.p-value: 0.91ANOVA
Primary
Sensory Median Nerve Amplitude
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12, and 24 weeks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Sensory Median Nerve Amplitude | 24 weeks | 4.52 uV | Standard Deviation 4.47 |
| Sedentary Control Group | Sensory Median Nerve Amplitude | Baseline | 3.14 uV | Standard Deviation 4.44 |
| Sedentary Control Group | Sensory Median Nerve Amplitude | 12 weeks | 2.41 uV | Standard Deviation 3.23 |
| Aerobic Exercise Group | Sensory Median Nerve Amplitude | 12 weeks | 6.00 uV | Standard Deviation 9.71 |
| Aerobic Exercise Group | Sensory Median Nerve Amplitude | 24 weeks | 6.06 uV | Standard Deviation 8.12 |
| Aerobic Exercise Group | Sensory Median Nerve Amplitude | Baseline | 5.55 uV | Standard Deviation 8.12 |
| Strength Exercise Group | Sensory Median Nerve Amplitude | 24 weeks | 4.97 uV | Standard Deviation 4.41 |
| Strength Exercise Group | Sensory Median Nerve Amplitude | Baseline | 6.91 uV | Standard Deviation 4.61 |
| Strength Exercise Group | Sensory Median Nerve Amplitude | 12 weeks | 6.26 uV | Standard Deviation 4.17 |
| Combined Aerobic and Strength Exercise Group | Sensory Median Nerve Amplitude | 12 weeks | 6.10 uV | Standard Deviation 6.99 |
| Combined Aerobic and Strength Exercise Group | Sensory Median Nerve Amplitude | 24 weeks | 4.31 uV | Standard Deviation 6.56 |
| Combined Aerobic and Strength Exercise Group | Sensory Median Nerve Amplitude | Baseline | 7.18 uV | Standard Deviation 6.88 |
Comparison: Evaluated within group across timep-value: 0.91ANOVA
Comparison: Evaluated within group across timep-value: 0.99ANOVA
Comparison: Evaluated within group across timep-value: 0.94ANOVA
Comparison: Evaluated within group across timep-value: 0.93ANOVA
Comparison: Comparison across groups at baselinep-value: 0.38ANOVA
Comparison: Comparison across groups at 12-wksp-value: 0.51ANOVA
Comparison: Comparison across groups at 24-wksp-value: 0.94ANOVA
Primary
Sensory Median Nerve Conduction Velocity
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 wks, 24 wks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Sensory Median Nerve Conduction Velocity | Baseline | 18.95 m/s | Standard Deviation 23.83 |
| Sedentary Control Group | Sensory Median Nerve Conduction Velocity | 24 weeks | 30.00 m/s | Standard Deviation 22.74 |
| Sedentary Control Group | Sensory Median Nerve Conduction Velocity | 12 weeks | 18.18 m/s | Standard Deviation 23.73 |
| Aerobic Exercise Group | Sensory Median Nerve Conduction Velocity | Baseline | 20.34 m/s | Standard Deviation 23.59 |
| Aerobic Exercise Group | Sensory Median Nerve Conduction Velocity | 24 weeks | 22.90 m/s | Standard Deviation 22.63 |
| Aerobic Exercise Group | Sensory Median Nerve Conduction Velocity | 12 weeks | 19.04 m/s | Standard Deviation 22.17 |
| Strength Exercise Group | Sensory Median Nerve Conduction Velocity | 12 weeks | 35.73 m/s | Standard Deviation 19.8 |
| Strength Exercise Group | Sensory Median Nerve Conduction Velocity | 24 weeks | 29.76 m/s | Standard Deviation 21.03 |
| Strength Exercise Group | Sensory Median Nerve Conduction Velocity | Baseline | 35.05 m/s | Standard Deviation 18.19 |
| Combined Aerobic and Strength Exercise Group | Sensory Median Nerve Conduction Velocity | 24 weeks | 22.88 m/s | Standard Deviation 25.21 |
| Combined Aerobic and Strength Exercise Group | Sensory Median Nerve Conduction Velocity | 12 weeks | 23.64 m/s | Standard Deviation 22.93 |
| Combined Aerobic and Strength Exercise Group | Sensory Median Nerve Conduction Velocity | Baseline | 30.49 m/s | Standard Deviation 25.08 |
Comparison: Evaluated within group across time.p-value: 1ANOVA
Comparison: Evaluated within group across time.p-value: 0.99ANOVA
Comparison: Evaluated within group across time.p-value: 1ANOVA
Comparison: Evaluated within group across time.p-value: 0.81ANOVA
Comparison: Comparison across groups at baselinep-value: 0.28ANOVA
Comparison: Comparison across groups at 12-wksp-value: 0.28ANOVA
Comparison: Comparison across groups at 24-wksp-value: 0.83ANOVA
Primary
Sensory Median Nerve Latency
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12wks, 24 wks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Sensory Median Nerve Latency | 24 weeks | 2.72 ms | Standard Deviation 2.07 |
| Sedentary Control Group | Sensory Median Nerve Latency | Baseline | 1.66 ms | Standard Deviation 2.05 |
| Sedentary Control Group | Sensory Median Nerve Latency | 12 weeks | 1.54 ms | Standard Deviation 1.99 |
| Aerobic Exercise Group | Sensory Median Nerve Latency | 12 weeks | 2.00 ms | Standard Deviation 2.36 |
| Aerobic Exercise Group | Sensory Median Nerve Latency | Baseline | 1.76 ms | Standard Deviation 2.06 |
| Aerobic Exercise Group | Sensory Median Nerve Latency | 24 weeks | 2.44 ms | Standard Deviation 2.43 |
| Strength Exercise Group | Sensory Median Nerve Latency | 24 weeks | 2.87 ms | Standard Deviation 2.03 |
| Strength Exercise Group | Sensory Median Nerve Latency | Baseline | 3.36 ms | Standard Deviation 1.75 |
| Strength Exercise Group | Sensory Median Nerve Latency | 12 weeks | 3.15 ms | Standard Deviation 1.75 |
| Combined Aerobic and Strength Exercise Group | Sensory Median Nerve Latency | 12 weeks | 2.19 ms | Standard Deviation 2.11 |
| Combined Aerobic and Strength Exercise Group | Sensory Median Nerve Latency | Baseline | 2.26 ms | Standard Deviation 1.83 |
| Combined Aerobic and Strength Exercise Group | Sensory Median Nerve Latency | 24 weeks | 1.81 ms | Standard Deviation 1.99 |
Comparison: Evaluated within group across timep-value: 0.99ANOVA
Comparison: Evaluated within group across time.p-value: 0.97ANOVA
Comparison: Evaluated within group across time.p-value: 0.96ANOVA
Comparison: Evaluated within group across time.p-value: 1ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.16ANOVA
Comparison: Comparison across groups at 12-wksp-value: 0.37ANOVA
Comparison: Comparison across groups at 24-wksp-value: 0.75ANOVA
Primary
Sensory Ulnar Nerve Amplitude
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 wks, 24 wks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Sensory Ulnar Nerve Amplitude | 24 weeks | 6.08 uV | Standard Deviation 5.12 |
| Sedentary Control Group | Sensory Ulnar Nerve Amplitude | 12 weeks | 4.68 uV | Standard Deviation 4.84 |
| Sedentary Control Group | Sensory Ulnar Nerve Amplitude | Baseline | 4.48 uV | Standard Deviation 4.08 |
| Aerobic Exercise Group | Sensory Ulnar Nerve Amplitude | 24 weeks | 4.12 uV | Standard Deviation 2.88 |
| Aerobic Exercise Group | Sensory Ulnar Nerve Amplitude | Baseline | 4.95 uV | Standard Deviation 5.1 |
| Aerobic Exercise Group | Sensory Ulnar Nerve Amplitude | 12 weeks | 4.44 uV | Standard Deviation 6.71 |
| Strength Exercise Group | Sensory Ulnar Nerve Amplitude | 12 weeks | 3.87 uV | Standard Deviation 5.41 |
| Strength Exercise Group | Sensory Ulnar Nerve Amplitude | Baseline | 5.60 uV | Standard Deviation 7.63 |
| Strength Exercise Group | Sensory Ulnar Nerve Amplitude | 24 weeks | 6.97 uV | Standard Deviation 6.17 |
| Combined Aerobic and Strength Exercise Group | Sensory Ulnar Nerve Amplitude | 24 weeks | 8.68 uV | Standard Deviation 6.89 |
| Combined Aerobic and Strength Exercise Group | Sensory Ulnar Nerve Amplitude | 12 weeks | 8.49 uV | Standard Deviation 5.89 |
| Combined Aerobic and Strength Exercise Group | Sensory Ulnar Nerve Amplitude | Baseline | 7.75 uV | Standard Deviation 5.77 |
Comparison: Evaluated within group across timep-value: 0.99ANOVA
Comparison: Evaluated within group across timep-value: 0.97ANOVA
Comparison: Evaluated within group across timep-value: 0.82ANOVA
Comparison: Evaluated within group across timep-value: 0.96ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.55ANOVA
Comparison: Comparison across groups at 12-wksp-value: 0.31ANOVA
Comparison: Comparison across groups at 24-wksp-value: 0.32ANOVA
Primary
Sensory Ulnar Nerve Conduction Velocity
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 wks, 24 wks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Sensory Ulnar Nerve Conduction Velocity | Baseline | 29.29 m/s | Standard Deviation 22.19 |
| Sedentary Control Group | Sensory Ulnar Nerve Conduction Velocity | 24 weeks | 34.10 m/s | Standard Deviation 19.48 |
| Sedentary Control Group | Sensory Ulnar Nerve Conduction Velocity | 12 weeks | 23.64 m/s | Standard Deviation 25.03 |
| Aerobic Exercise Group | Sensory Ulnar Nerve Conduction Velocity | Baseline | 24.68 m/s | Standard Deviation 23.94 |
| Aerobic Exercise Group | Sensory Ulnar Nerve Conduction Velocity | 24 weeks | 30.91 m/s | Standard Deviation 20.12 |
| Aerobic Exercise Group | Sensory Ulnar Nerve Conduction Velocity | 12 weeks | 20.59 m/s | Standard Deviation 23.99 |
| Strength Exercise Group | Sensory Ulnar Nerve Conduction Velocity | 12 weeks | 19.81 m/s | Standard Deviation 25.83 |
| Strength Exercise Group | Sensory Ulnar Nerve Conduction Velocity | Baseline | 20.61 m/s | Standard Deviation 24.06 |
| Strength Exercise Group | Sensory Ulnar Nerve Conduction Velocity | 24 weeks | 31.54 m/s | Standard Deviation 22.09 |
| Combined Aerobic and Strength Exercise Group | Sensory Ulnar Nerve Conduction Velocity | Baseline | 39.27 m/s | Standard Deviation 20.14 |
| Combined Aerobic and Strength Exercise Group | Sensory Ulnar Nerve Conduction Velocity | 24 weeks | 36.06 m/s | Standard Deviation 23.31 |
| Combined Aerobic and Strength Exercise Group | Sensory Ulnar Nerve Conduction Velocity | 12 weeks | 36.40 m/s | Standard Deviation 20.87 |
Comparison: Evaluated within group across time.p-value: 0.83ANOVA
Comparison: Evaluated within group across time.p-value: 0.91ANOVA
Comparison: Evaluated within group across time.p-value: 1ANOVA
Comparison: Evaluated within group across time.p-value: 0.95ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.26ANOVA
Comparison: Comparison across groups at 12-wksp-value: 0.42ANOVA
Comparison: Comparison across groups at 24-wks.p-value: 0.95ANOVA
Primary
Sensory Ulnar Nerve Latency
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 wks, 24 wks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Sensory Ulnar Nerve Latency | Baseline | 2.25 ms | Standard Deviation 1.73 |
| Sedentary Control Group | Sensory Ulnar Nerve Latency | 24 weeks | 2.56 ms | Standard Deviation 1.47 |
| Sedentary Control Group | Sensory Ulnar Nerve Latency | 12 weeks | 1.82 ms | Standard Deviation 1.58 |
| Aerobic Exercise Group | Sensory Ulnar Nerve Latency | Baseline | 1.78 ms | Standard Deviation 1.72 |
| Aerobic Exercise Group | Sensory Ulnar Nerve Latency | 24 weeks | 2.53 ms | Standard Deviation 1.66 |
| Aerobic Exercise Group | Sensory Ulnar Nerve Latency | 12 weeks | 1.49 ms | Standard Deviation 1.75 |
| Strength Exercise Group | Sensory Ulnar Nerve Latency | 12 weeks | 1.24 ms | Standard Deviation 1.64 |
| Strength Exercise Group | Sensory Ulnar Nerve Latency | Baseline | 1.50 ms | Standard Deviation 1.76 |
| Strength Exercise Group | Sensory Ulnar Nerve Latency | 24 weeks | 2.36 ms | Standard Deviation 1.66 |
| Combined Aerobic and Strength Exercise Group | Sensory Ulnar Nerve Latency | Baseline | 2.46 ms | Standard Deviation 1.26 |
| Combined Aerobic and Strength Exercise Group | Sensory Ulnar Nerve Latency | 24 weeks | 2.24 ms | Standard Deviation 1.45 |
| Combined Aerobic and Strength Exercise Group | Sensory Ulnar Nerve Latency | 12 weeks | 2.36 ms | Standard Deviation 1.39 |
Comparison: Evaluated within group across time.p-value: 0.81ANOVA
Comparison: Evaluated within group across time.p-value: 0.92ANOVA
Comparison: Evaluated within group across time.p-value: 0.93ANOVA
Comparison: Evaluated within group across time.p-value: 0.99ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.5ANOVA
Comparison: Comparison across groups at 12-wks.p-value: 0.47ANOVA
Comparison: Comparison across groups at 24-wksp-value: 0.97ANOVA
Primary
Sural Nerve Amplitude
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12, and 24 weeks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation. Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Sural Nerve Amplitude | 12 weeks | 2.88 uV | Standard Deviation 3.84 |
| Sedentary Control Group | Sural Nerve Amplitude | 24 weeks | 2.17 uV | Standard Deviation 3.28 |
| Sedentary Control Group | Sural Nerve Amplitude | Baseline | 1.22 uV | Standard Deviation 2.93 |
| Aerobic Exercise Group | Sural Nerve Amplitude | Baseline | 2.37 uV | Standard Deviation 4.2 |
| Aerobic Exercise Group | Sural Nerve Amplitude | 24 weeks | 2.93 uV | Standard Deviation 3.39 |
| Aerobic Exercise Group | Sural Nerve Amplitude | 12 weeks | 1.49 uV | Standard Deviation 2.58 |
| Strength Exercise Group | Sural Nerve Amplitude | 24 weeks | 0.86 uV | Standard Deviation 2.72 |
| Strength Exercise Group | Sural Nerve Amplitude | 12 weeks | 0.58 uV | Standard Deviation 1.83 |
| Strength Exercise Group | Sural Nerve Amplitude | Baseline | 0.88 uV | Standard Deviation 2.92 |
| Combined Aerobic and Strength Exercise Group | Sural Nerve Amplitude | 24 weeks | 0.65 uV | Standard Deviation 1.84 |
| Combined Aerobic and Strength Exercise Group | Sural Nerve Amplitude | Baseline | 0.86 uV | Standard Deviation 1.93 |
| Combined Aerobic and Strength Exercise Group | Sural Nerve Amplitude | 12 weeks | 1.21 uV | Standard Deviation 2.41 |
Comparison: Evaluated within group across timep-value: 0.49ANOVA
Comparison: Evaluated within group across timep-value: 0.82ANOVA
Comparison: Evaluated within group across timep-value: 0.96ANOVA
Comparison: Evaluated within group across timep-value: 0.93ANOVA
Comparison: Comparison across groups at baselinep-value: 0.63ANOVA
Comparison: Comparison across groups at 12-wkp-value: 0.31ANOVA
Comparison: Comparison across groups at 24-wkp-value: 0.28ANOVA
Primary
Sural Nerve Conduction Velocity
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 wks, 24 wks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Sural Nerve Conduction Velocity | 24 weeks | 12.38 m/s | Standard Deviation 18.63 |
| Sedentary Control Group | Sural Nerve Conduction Velocity | 12 weeks | 16.46 m/s | Standard Deviation 21.32 |
| Sedentary Control Group | Sural Nerve Conduction Velocity | baseline | 6.21 m/s | Standard Deviation 14.5 |
| Aerobic Exercise Group | Sural Nerve Conduction Velocity | 24 weeks | 18.54 m/s | Standard Deviation 21.48 |
| Aerobic Exercise Group | Sural Nerve Conduction Velocity | baseline | 11.1 m/s | Standard Deviation 19.26 |
| Aerobic Exercise Group | Sural Nerve Conduction Velocity | 12 weeks | 10.55 m/s | Standard Deviation 18.24 |
| Strength Exercise Group | Sural Nerve Conduction Velocity | 12 weeks | 3.73 m/s | Standard Deviation 11.8 |
| Strength Exercise Group | Sural Nerve Conduction Velocity | baseline | 3.27 m/s | Standard Deviation 10.85 |
| Strength Exercise Group | Sural Nerve Conduction Velocity | 24 weeks | 3.88 m/s | Standard Deviation 12.27 |
| Combined Aerobic and Strength Exercise Group | Sural Nerve Conduction Velocity | 24 weeks | 5.34 m/s | Standard Deviation 15.1 |
| Combined Aerobic and Strength Exercise Group | Sural Nerve Conduction Velocity | 12 weeks | 8.62 m/s | Standard Deviation 17.14 |
| Combined Aerobic and Strength Exercise Group | Sural Nerve Conduction Velocity | baseline | 7.35 m/s | Standard Deviation 16.38 |
Comparison: Evaluated within group across timep-value: 0.39ANOVA
Comparison: Evaluated within group across timep-value: 1ANOVA
Comparison: Evaluated within group across timep-value: 1ANOVA
Comparison: Evaluated within group across timep-value: 0.98ANOVA
Comparison: Comparison across groups at baselinep-value: 0.7ANOVA
Comparison: Comparison across groups at 12-wksp-value: 0.45ANOVA
Comparison: Comparison across groups at 24-wksp-value: 0.22ANOVA
Primary
Sural Nerve Latency
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 wks, 24 wks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Sural Nerve Latency | 24 weeks | 1.26 ms | Standard Deviation 1.91 |
| Sedentary Control Group | Sural Nerve Latency | Baseline | 0.61 ms | Standard Deviation 1.43 |
| Sedentary Control Group | Sural Nerve Latency | 12 weeks | 1.41 ms | Standard Deviation 1.83 |
| Aerobic Exercise Group | Sural Nerve Latency | 24 weeks | 1.57 ms | Standard Deviation 1.86 |
| Aerobic Exercise Group | Sural Nerve Latency | 12 weeks | 1.04 ms | Standard Deviation 1.79 |
| Aerobic Exercise Group | Sural Nerve Latency | Baseline | 1.01 ms | Standard Deviation 1.73 |
| Strength Exercise Group | Sural Nerve Latency | 12 weeks | 0.42 ms | Standard Deviation 1.33 |
| Strength Exercise Group | Sural Nerve Latency | 24 weeks | 0.4 ms | Standard Deviation 1.26 |
| Strength Exercise Group | Sural Nerve Latency | Baseline | 0.39 ms | Standard Deviation 1.3 |
| Combined Aerobic and Strength Exercise Group | Sural Nerve Latency | 24 weeks | 0.48 ms | Standard Deviation 1.34 |
| Combined Aerobic and Strength Exercise Group | Sural Nerve Latency | Baseline | 0.64 ms | Standard Deviation 1.43 |
| Combined Aerobic and Strength Exercise Group | Sural Nerve Latency | 12 weeks | 0.89 ms | Standard Deviation 1.76 |
Comparison: Evaluated within group across timep-value: 0.53ANOVA
Comparison: Evaluated within group across timep-value: 1ANOVA
Comparison: Evaluated within group across timep-value: 1ANOVA
Comparison: Evaluated within group across timep-value: 0.93ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.8ANOVA
Comparison: Comparison across groups at 12-wksp-value: 0.63ANOVA
Comparison: Comparison across groups at 24-wkp-value: 0.31ANOVA
Primary
Tibial Nerve Amplitude
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 weeks, 24 weeks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Tibial Nerve Amplitude | Baseline | 2.97 mV | Standard Deviation 3.13 |
| Sedentary Control Group | Tibial Nerve Amplitude | 24 wks | 3.48 mV | Standard Deviation 3.62 |
| Sedentary Control Group | Tibial Nerve Amplitude | 12 wks | 3.26 mV | Standard Deviation 3.32 |
| Aerobic Exercise Group | Tibial Nerve Amplitude | Baseline | 3.71 mV | Standard Deviation 3.91 |
| Aerobic Exercise Group | Tibial Nerve Amplitude | 24 wks | 3.46 mV | Standard Deviation 3.57 |
| Aerobic Exercise Group | Tibial Nerve Amplitude | 12 wks | 3.03 mV | Standard Deviation 3.39 |
| Strength Exercise Group | Tibial Nerve Amplitude | 12 wks | 3.73 mV | Standard Deviation 3.93 |
| Strength Exercise Group | Tibial Nerve Amplitude | Baseline | 3.35 mV | Standard Deviation 3.43 |
| Strength Exercise Group | Tibial Nerve Amplitude | 24 wks | 3.90 mV | Standard Deviation 4.04 |
| Combined Aerobic and Strength Exercise Group | Tibial Nerve Amplitude | Baseline | 4.71 mV | Standard Deviation 3.73 |
| Combined Aerobic and Strength Exercise Group | Tibial Nerve Amplitude | 24 wks | 3.33 mV | Standard Deviation 3.68 |
| Combined Aerobic and Strength Exercise Group | Tibial Nerve Amplitude | 12 wks | 3.59 mV | Standard Deviation 3.75 |
Comparison: Evaluated within group across timep-value: 0.98ANOVA
Comparison: Evaluated within group across timep-value: 0.9ANOVA
Comparison: Evaluated within group across timep-value: 0.97ANOVA
Comparison: Evaluated within group across timep-value: 0.78ANOVA
Comparison: Comparison across groups at baselinep-value: 0.63ANOVA
Comparison: Comparison across groups at 12-wkp-value: 0.97ANOVA
Comparison: Comparison across groups at 24-wksp-value: 0.99ANOVA
Primary
Tibial Nerve Conduction Velocity
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 weeks, 24 weeks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Tibial Nerve Conduction Velocity | 12 wks | 32.56 m/s | Standard Deviation 12.51 |
| Sedentary Control Group | Tibial Nerve Conduction Velocity | 24 wks | 30.22 m/s | Standard Deviation 13.43 |
| Sedentary Control Group | Tibial Nerve Conduction Velocity | Baseline | 31.81 m/s | Standard Deviation 10.42 |
| Aerobic Exercise Group | Tibial Nerve Conduction Velocity | Baseline | 33.15 m/s | Standard Deviation 4.01 |
| Aerobic Exercise Group | Tibial Nerve Conduction Velocity | 24 wks | 34.22 m/s | Standard Deviation 4.17 |
| Aerobic Exercise Group | Tibial Nerve Conduction Velocity | 12 wks | 30.77 m/s | Standard Deviation 11.05 |
| Strength Exercise Group | Tibial Nerve Conduction Velocity | 12 wks | 30.64 m/s | Standard Deviation 11.52 |
| Strength Exercise Group | Tibial Nerve Conduction Velocity | Baseline | 30.0 m/s | Standard Deviation 10.29 |
| Strength Exercise Group | Tibial Nerve Conduction Velocity | 24 wks | 28.51 m/s | Standard Deviation 15.85 |
| Combined Aerobic and Strength Exercise Group | Tibial Nerve Conduction Velocity | Baseline | 30.43 m/s | Standard Deviation 10.58 |
| Combined Aerobic and Strength Exercise Group | Tibial Nerve Conduction Velocity | 24 wks | 31.73 m/s | Standard Deviation 5.58 |
| Combined Aerobic and Strength Exercise Group | Tibial Nerve Conduction Velocity | 12 wks | 31.08 m/s | Standard Deviation 11.9 |
Comparison: Evaluated within group across timep-value: 0.99ANOVA
Comparison: Evaluated within group across timep-value: 0.72ANOVA
Comparison: Evaluated within group across timep-value: 0.99ANOVA
Comparison: Evaluated within group across timep-value: 0.99ANOVA
Comparison: Comparison across groups at baselinep-value: 0.85ANOVA
Comparison: Comparison across groups at 12-wksp-value: 0.98ANOVA
Comparison: Comparison across groups at 24-wksp-value: 0.68ANOVA
Primary
Tibial Nerve Latency
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Time frame: Baseline, 12 weeks, 24 weeks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Tibial Nerve Latency | 24 wks | 4.41 ms | Standard Deviation 1.7 |
| Sedentary Control Group | Tibial Nerve Latency | Baseline | 4.37 ms | Standard Deviation 1.5 |
| Sedentary Control Group | Tibial Nerve Latency | 12 wks | 4.15 ms | Standard Deviation 1.62 |
| Aerobic Exercise Group | Tibial Nerve Latency | 24 wks | 5.25 ms | Standard Deviation 0.57 |
| Aerobic Exercise Group | Tibial Nerve Latency | 12 wks | 4.65 ms | Standard Deviation 1.62 |
| Aerobic Exercise Group | Tibial Nerve Latency | Baseline | 5.03 ms | Standard Deviation 0.72 |
| Strength Exercise Group | Tibial Nerve Latency | 12 wks | 4.28 ms | Standard Deviation 1.65 |
| Strength Exercise Group | Tibial Nerve Latency | Baseline | 4.43 ms | Standard Deviation 1.56 |
| Strength Exercise Group | Tibial Nerve Latency | 24 wks | 4.40 ms | Standard Deviation 2.43 |
| Combined Aerobic and Strength Exercise Group | Tibial Nerve Latency | 12 wks | 4.29 ms | Standard Deviation 1.78 |
| Combined Aerobic and Strength Exercise Group | Tibial Nerve Latency | Baseline | 4.11 ms | Standard Deviation 1.47 |
| Combined Aerobic and Strength Exercise Group | Tibial Nerve Latency | 24 wks | 5.29 ms | Standard Deviation 1.76 |
Comparison: Evaluated within group across timep-value: 0.94ANOVA
Comparison: Evaluated within group across timep-value: 0.69ANOVA
Comparison: Evaluated within group across timep-value: 0.98ANOVA
Comparison: Evaluated within group across timep-value: 0.97ANOVA
Comparison: Comparison across groups at baselinep-value: 0.45ANOVA
Comparison: Comparison across groups at 12-wksp-value: 0.91ANOVA
Comparison: Comparison across groups at 24-wksp-value: 0.51ANOVA
Secondary
Maximum Respiratory Exchange Ratio (RER) During TMT
Peak RER achieved while undergoing a modified Bruce Protocol treadmill test (TMT). This is a mathematical ratio of maximally achieved (peak) VCO2 divided by maximally achieved (peak) VO2.
Time frame: Baseline, 12-wks, 24-wks
Population: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Maximum Respiratory Exchange Ratio (RER) During TMT | Baseline | 1.2 ratio | Standard Deviation 0.1 |
| Sedentary Control Group | Maximum Respiratory Exchange Ratio (RER) During TMT | 24-weeks | 1.2 ratio | Standard Deviation 0.1 |
| Sedentary Control Group | Maximum Respiratory Exchange Ratio (RER) During TMT | 12-weeks | 1.2 ratio | Standard Deviation 0.1 |
| Aerobic Exercise Group | Maximum Respiratory Exchange Ratio (RER) During TMT | Baseline | 1.2 ratio | Standard Deviation 0.2 |
| Aerobic Exercise Group | Maximum Respiratory Exchange Ratio (RER) During TMT | 24-weeks | 1.2 ratio | Standard Deviation 0.1 |
| Aerobic Exercise Group | Maximum Respiratory Exchange Ratio (RER) During TMT | 12-weeks | 1.2 ratio | Standard Deviation 0.1 |
| Strength Exercise Group | Maximum Respiratory Exchange Ratio (RER) During TMT | 12-weeks | 1.2 ratio | Standard Deviation 0.1 |
| Strength Exercise Group | Maximum Respiratory Exchange Ratio (RER) During TMT | Baseline | 1.1 ratio | Standard Deviation 0.1 |
| Strength Exercise Group | Maximum Respiratory Exchange Ratio (RER) During TMT | 24-weeks | 1.1 ratio | Standard Deviation 0.1 |
| Combined Aerobic and Strength Exercise Group | Maximum Respiratory Exchange Ratio (RER) During TMT | Baseline | 1.1 ratio | Standard Deviation 0.1 |
| Combined Aerobic and Strength Exercise Group | Maximum Respiratory Exchange Ratio (RER) During TMT | 24-weeks | 1.1 ratio | Standard Deviation 0 |
| Combined Aerobic and Strength Exercise Group | Maximum Respiratory Exchange Ratio (RER) During TMT | 12-weeks | 1.2 ratio | Standard Deviation 0.1 |
Comparison: Evaluate within group across timep-value: 0.97ANOVA
Comparison: Evaluate within group across time.p-value: 1ANOVA
Comparison: Evaluate within group across time.p-value: 0.09ANOVA
Comparison: Evaluate within group across time.p-value: 0.05ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.11ANOVA
Comparison: Comparison across groups at 12-wks.p-value: 0.41ANOVA
Comparison: Comparison across groups at 24-wks.p-value: 0.03ANOVA
Secondary
Short Form-36V: Mental Component Score
The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Mental Component scores reflect perceived changes in emotional health relative to the previous year.
Time frame: initial entry into study, and at 12-wks and 24-wks
Population: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Short Form-36V: Mental Component Score | Baseline | 68.8 score on a scale | Standard Deviation 32.2 |
| Sedentary Control Group | Short Form-36V: Mental Component Score | 24-wks | 75.0 score on a scale | Standard Deviation 21.7 |
| Sedentary Control Group | Short Form-36V: Mental Component Score | 12-wks | 65.0 score on a scale | Standard Deviation 17.5 |
| Aerobic Exercise Group | Short Form-36V: Mental Component Score | Baseline | 63.6 score on a scale | Standard Deviation 30.3 |
| Aerobic Exercise Group | Short Form-36V: Mental Component Score | 24-wks | 75.0 score on a scale | Standard Deviation 19.4 |
| Aerobic Exercise Group | Short Form-36V: Mental Component Score | 12-wks | 72.7 score on a scale | Standard Deviation 20.8 |
| Strength Exercise Group | Short Form-36V: Mental Component Score | 12-wks | 60.0 score on a scale | Standard Deviation 26.9 |
| Strength Exercise Group | Short Form-36V: Mental Component Score | Baseline | 59.1 score on a scale | Standard Deviation 25.7 |
| Strength Exercise Group | Short Form-36V: Mental Component Score | 24-wks | 67.5 score on a scale | Standard Deviation 33.4 |
| Combined Aerobic and Strength Exercise Group | Short Form-36V: Mental Component Score | Baseline | 61.4 score on a scale | Standard Deviation 28.2 |
| Combined Aerobic and Strength Exercise Group | Short Form-36V: Mental Component Score | 24-wks | 75.0 score on a scale | Standard Deviation 25 |
| Combined Aerobic and Strength Exercise Group | Short Form-36V: Mental Component Score | 12-wks | 72.2 score on a scale | Standard Deviation 26.4 |
Comparison: Evaluate within group across timep-value: 1Kruskal-Wallis
Comparison: Evaluate within group across timep-value: 1Kruskal-Wallis
Comparison: Evaluate within group across timep-value: 1Kruskal-Wallis
Comparison: Evaluate within group across time.p-value: 1Kruskal-Wallis
Comparison: Comparison across groups at baselinep-value: 0.81Kruskal-Wallis
Comparison: Comparison across groups at 12-wksp-value: 0.6Kruskal-Wallis
Comparison: Comparison across groups at 24-wksp-value: 0.99Kruskal-Wallis
Secondary
Short Form-36V: Physical Component Score
The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Physical Component scores reflect perceived changes in physical health relative to the previous year.
Time frame: Initial entry into study, 12 and 24 weeks
Population: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Short Form-36V: Physical Component Score | Baseline | 60.4 score on a scale | Standard Deviation 29.1 |
| Sedentary Control Group | Short Form-36V: Physical Component Score | 24-weeks | 58.3 score on a scale | Standard Deviation 21.7 |
| Sedentary Control Group | Short Form-36V: Physical Component Score | 12-weeks | 57.5 score on a scale | Standard Deviation 23.7 |
| Aerobic Exercise Group | Short Form-36V: Physical Component Score | Baseline | 52.3 score on a scale | Standard Deviation 26.1 |
| Aerobic Exercise Group | Short Form-36V: Physical Component Score | 24-weeks | 86.4 score on a scale | Standard Deviation 17.2 |
| Aerobic Exercise Group | Short Form-36V: Physical Component Score | 12-weeks | 86.4 score on a scale | Standard Deviation 17.2 |
| Strength Exercise Group | Short Form-36V: Physical Component Score | 12-weeks | 65.0 score on a scale | Standard Deviation 26.9 |
| Strength Exercise Group | Short Form-36V: Physical Component Score | Baseline | 56.8 score on a scale | Standard Deviation 25.2 |
| Strength Exercise Group | Short Form-36V: Physical Component Score | 24-weeks | 77.5 score on a scale | Standard Deviation 32.2 |
| Combined Aerobic and Strength Exercise Group | Short Form-36V: Physical Component Score | Baseline | 59.1 score on a scale | Standard Deviation 28 |
| Combined Aerobic and Strength Exercise Group | Short Form-36V: Physical Component Score | 24-weeks | 75.0 score on a scale | Standard Deviation 32.3 |
| Combined Aerobic and Strength Exercise Group | Short Form-36V: Physical Component Score | 12-weeks | 72.2 score on a scale | Standard Deviation 29.2 |
Comparison: Evaluate within group across timep-value: 1Kruskal-Wallis
Comparison: Evaluate within group across timep-value: 0.01Kruskal-Wallis
Comparison: Evaluate within group across timep-value: 1Kruskal-Wallis
Comparison: Evaluate within group across timep-value: 0.98Kruskal-Wallis
Comparison: Comparison across groups at baselinep-value: 0.96Kruskal-Wallis
Comparison: Comparison across groups at 12-wksp-value: 0.06Kruskal-Wallis
Comparison: Comparison across groups at 24-wksp-value: 0.14Kruskal-Wallis
Secondary
Symptom-Limited TMT Blood Glucose Response
Changes in blood glucose in response to modified Bruce Protocol treadmill test (TMT)
Time frame: Initial entry into study, 12 and 24 weeks
Population: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/co-PI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Symptom-Limited TMT Blood Glucose Response | 24-weeks-Pre Exercise | 163.9 mg/dl | Standard Deviation 46 |
| Sedentary Control Group | Symptom-Limited TMT Blood Glucose Response | 24-weeks-Post Exercise | 143.6 mg/dl | Standard Deviation 33.8 |
| Sedentary Control Group | Symptom-Limited TMT Blood Glucose Response | Baseline-Post Exercise | 129.3 mg/dl | Standard Deviation 41.7 |
| Sedentary Control Group | Symptom-Limited TMT Blood Glucose Response | Baseline-Pre Exercise | 157.3 mg/dl | Standard Deviation 49.5 |
| Sedentary Control Group | Symptom-Limited TMT Blood Glucose Response | 12-weeks-Pre Exercise | 188.7 mg/dl | Standard Deviation 68.6 |
| Sedentary Control Group | Symptom-Limited TMT Blood Glucose Response | 12-weeks-Post Exercise | 127.3 mg/dl | Standard Deviation 36 |
| Aerobic Exercise Group | Symptom-Limited TMT Blood Glucose Response | 12-weeks-Post Exercise | 151.1 mg/dl | Standard Deviation 41.4 |
| Aerobic Exercise Group | Symptom-Limited TMT Blood Glucose Response | 24-weeks-Pre Exercise | 181.8 mg/dl | Standard Deviation 62.9 |
| Aerobic Exercise Group | Symptom-Limited TMT Blood Glucose Response | Baseline-Post Exercise | 169.4 mg/dl | Standard Deviation 46 |
| Aerobic Exercise Group | Symptom-Limited TMT Blood Glucose Response | 24-weeks-Post Exercise | 166.3 mg/dl | Standard Deviation 57.9 |
| Aerobic Exercise Group | Symptom-Limited TMT Blood Glucose Response | 12-weeks-Pre Exercise | 171.7 mg/dl | Standard Deviation 47.9 |
| Aerobic Exercise Group | Symptom-Limited TMT Blood Glucose Response | Baseline-Pre Exercise | 188.6 mg/dl | Standard Deviation 65.6 |
| Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | 12-weeks-Pre Exercise | 170.6 mg/dl | Standard Deviation 43.9 |
| Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | Baseline-Post Exercise | 138.5 mg/dl | Standard Deviation 48.7 |
| Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | 12-weeks-Post Exercise | 147.2 mg/dl | Standard Deviation 59.7 |
| Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | Baseline-Pre Exercise | 181.5 mg/dl | Standard Deviation 48.9 |
| Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | 24-weeks-Pre Exercise | 187.9 mg/dl | Standard Deviation 53.6 |
| Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | 24-weeks-Post Exercise | 161.9 mg/dl | Standard Deviation 43.5 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | 24-weeks-Post Exercise | 139.4 mg/dl | Standard Deviation 45.9 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | Baseline-Pre Exercise | 180.7 mg/dl | Standard Deviation 43.2 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | Baseline-Post Exercise | 149.5 mg/dl | Standard Deviation 46.1 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | 12-weeks-Pre Exercise | 160.0 mg/dl | Standard Deviation 51.2 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | 12-weeks-Post Exercise | 128.0 mg/dl | Standard Deviation 28.7 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Blood Glucose Response | 24-weeks-Pre Exercise | 169.0 mg/dl | Standard Deviation 48.9 |
Comparison: Evaluate within group pre- and post-test responses across time.p-value: 0.03t-test, 2 sided
Comparison: Evaluate within group pre- and post-test responses across time.p-value: 0.29t-test, 2 sided
Comparison: Evaluate within group pre- and post-test responses across time.p-value: 0.36t-test, 2 sided
Comparison: Evaluate within group pre- and post-test responses across time.p-value: 0.15t-test, 2 sided
Comparison: Comparison of pre- and post-responses across groups at baseline.p-value: 0.2ANOVA
Comparison: Comparison of pre- and post-test responses across groups at 12 wks.p-value: 0.51ANOVA
Comparison: Comparison of pre- and post-test responses across groups at 24 wks.p-value: 0.59ANOVA
Secondary
Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2)
Peak Carbon Dioxide expelled achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Time frame: Baseline, 12-wks, 24-wks
Population: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | 12-weeks | 19.7 ml/min/kg | Standard Deviation 4.9 |
| Sedentary Control Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | 24-weeks | 20.2 ml/min/kg | Standard Deviation 6.3 |
| Sedentary Control Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | Baseline | 20.4 ml/min/kg | Standard Deviation 4.7 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | Baseline | 22.0 ml/min/kg | Standard Deviation 6.4 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | 12-weeks | 21.9 ml/min/kg | Standard Deviation 7.3 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | 24-weeks | 22.5 ml/min/kg | Standard Deviation 7.1 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | 12-weeks | 19.9 ml/min/kg | Standard Deviation 3.9 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | Baseline | 18.9 ml/min/kg | Standard Deviation 5.4 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | 24-weeks | 18.7 ml/min/kg | Standard Deviation 3.4 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | Baseline | 20.7 ml/min/kg | Standard Deviation 4.1 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | 24-weeks | 23.4 ml/min/kg | Standard Deviation 4.8 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | 12-weeks | 23.7 ml/min/kg | Standard Deviation 7.4 |
Comparison: Evaluate within group across time.p-value: 0.95ANOVA
Comparison: Evaluate within group across time.p-value: 1ANOVA
Comparison: Evaluate within group across time.p-value: 0.87ANOVA
Comparison: Evaluate within group across time.p-value: 0.48ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.58ANOVA
Comparison: Comparison across groups at 12-wks.p-value: 0.5ANOVA
Comparison: Comparison across groups at 24-wks.p-value: 0.33ANOVA
Secondary
Symptom-Limited TMT Maximum Heart Rate
Peak heart rate achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Time frame: baseline, 12-wks, 24-wks
Population: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Symptom-Limited TMT Maximum Heart Rate | Baseline | 128.5 beats per min | Standard Deviation 31.9 |
| Sedentary Control Group | Symptom-Limited TMT Maximum Heart Rate | 24-weeks | 127.4 beats per min | Standard Deviation 29.3 |
| Sedentary Control Group | Symptom-Limited TMT Maximum Heart Rate | 12-weeks | 125.8 beats per min | Standard Deviation 37.9 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Heart Rate | Baseline | 141.5 beats per min | Standard Deviation 18.9 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Heart Rate | 24-weeks | 140.5 beats per min | Standard Deviation 24.1 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Heart Rate | 12-weeks | 143.1 beats per min | Standard Deviation 21.6 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Heart Rate | 12-weeks | 126.0 beats per min | Standard Deviation 24.9 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Heart Rate | Baseline | 135.5 beats per min | Standard Deviation 26.6 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Heart Rate | 24-weeks | 129.3 beats per min | Standard Deviation 21.4 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Heart Rate | Baseline | 146.0 beats per min | Standard Deviation 23.3 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Heart Rate | 24-weeks | 143.3 beats per min | Standard Deviation 16.8 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Heart Rate | 12-weeks | 135.9 beats per min | Standard Deviation 25.4 |
Comparison: Evaluate within group across time.p-value: 0.98ANOVA
Comparison: Evaluate within group across time.p-value: 0.98ANOVA
Comparison: Evaluate within group across time.p-value: 0.67ANOVA
Comparison: Evaluate within group across time.p-value: 0.55ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.4ANOVA
Comparison: Comparison across groups at 12 wks.p-value: 0.47ANOVA
Comparison: Comparison across groups at 24 wks.p-value: 0.43ANOVA
Secondary
Symptom-Limited TMT Maximum METS Achieved (MET)
Peak metabolic rate equivalents (METS) achieved while undergoing a modified Bruce Protocol treadmill test (TMT). One MET is defined as the metabolic rate observed at rest, quantified as resting oxygen consumption of 250 ml/min (Male) or 200 ml /min (female). A value of 5 METS would represent a metabolic rate that is 5x that at rest and is considered an indicator of how hard a given individual is exercising. Data shown are expressed as a ratio at peak of exercise of oxygen consumed relative to normalized values for men or women at rest.
Time frame: Baseline, 12-wks, 24-wks
Population: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Symptom-Limited TMT Maximum METS Achieved (MET) | Baseline | 5.0 ratio | Standard Deviation 1.1 |
| Sedentary Control Group | Symptom-Limited TMT Maximum METS Achieved (MET) | 24-weeks | 5.2 ratio | Standard Deviation 1.3 |
| Sedentary Control Group | Symptom-Limited TMT Maximum METS Achieved (MET) | 12-weeks | 4.9 ratio | Standard Deviation 1.3 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum METS Achieved (MET) | Baseline | 5.4 ratio | Standard Deviation 1.2 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum METS Achieved (MET) | 24-weeks | 5.5 ratio | Standard Deviation 1.5 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum METS Achieved (MET) | 12-weeks | 5.4 ratio | Standard Deviation 1.4 |
| Strength Exercise Group | Symptom-Limited TMT Maximum METS Achieved (MET) | 12-weeks | 4.9 ratio | Standard Deviation 0.9 |
| Strength Exercise Group | Symptom-Limited TMT Maximum METS Achieved (MET) | Baseline | 4.7 ratio | Standard Deviation 1.1 |
| Strength Exercise Group | Symptom-Limited TMT Maximum METS Achieved (MET) | 24-weeks | 4.8 ratio | Standard Deviation 0.6 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum METS Achieved (MET) | Baseline | 5.4 ratio | Standard Deviation 1 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum METS Achieved (MET) | 24-weeks | 5.9 ratio | Standard Deviation 1.2 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum METS Achieved (MET) | 12-weeks | 5.6 ratio | Standard Deviation 1.3 |
Comparison: Evaluate within group across time.p-value: 0.98ANOVA
Comparison: Evaluate within group across time.p-value: 1ANOVA
Comparison: Evaluate within group across time.p-value: 0.88ANOVA
Comparison: Evaluate within group across time.p-value: 0.93ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.38ANOVA
Comparison: Comparison across groups at 12-wks.p-value: 0.55ANOVA
Comparison: Comparison across groups at 24-wksp-value: 0.37ANOVA
Secondary
Symptom-Limited TMT Maximum Minute Ventilation (VE)
Peak volume of air exchanged per minute achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Time frame: Baseline, 12-wks, 24-wks
Population: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | Baseline | 62.9 liters/min | Standard Deviation 15.3 |
| Sedentary Control Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | 24-weeks | 57.4 liters/min | Standard Deviation 13.1 |
| Sedentary Control Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | 12-weeks | 59.9 liters/min | Standard Deviation 10.6 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | Baseline | 63.5 liters/min | Standard Deviation 18.8 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | 24-weeks | 73.2 liters/min | Standard Deviation 27.3 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | 12-weeks | 67.0 liters/min | Standard Deviation 22.2 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | 12-weeks | 60.6 liters/min | Standard Deviation 12.1 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | Baseline | 54.3 liters/min | Standard Deviation 12.9 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | 24-weeks | 56.4 liters/min | Standard Deviation 12.4 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | Baseline | 62.0 liters/min | Standard Deviation 13.3 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | 24-weeks | 68.8 liters/min | Standard Deviation 13.1 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Minute Ventilation (VE) | 12-weeks | 62.4 liters/min | Standard Deviation 15.5 |
Comparison: Evaluate within group across time.p-value: 0.87ANOVA
Comparison: Evaluate within group across time.p-value: 0.93ANOVA
Comparison: Evaluate within group across time.p-value: 0.51ANOVA
Comparison: Evaluate within group across time.p-value: 0.89ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.46ANOVA
Comparison: Comparison across groups at 12 wks.p-value: 0.72ANOVA
Comparison: Comparison across groups at 24wks.p-value: 0.22ANOVA
Secondary
Symptom-Limited TMT Maximum Oxygen Uptake (VO2)
Peak Oxygen uptake achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Time frame: Baseline, 12-wks, 24-wks
Population: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | Baseline | 17.4 ml/min/kg | Standard Deviation 3.9 |
| Sedentary Control Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | 24-weeks | 18.2 ml/min/kg | Standard Deviation 4.6 |
| Sedentary Control Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | 12-weeks | 17.0 ml/min/kg | Standard Deviation 4.6 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | Baseline | 18.9 ml/min/kg | Standard Deviation 4.2 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | 24-weeks | 19.3 ml/min/kg | Standard Deviation 5.3 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | 12-weeks | 18.7 ml/min/kg | Standard Deviation 5.1 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | 12-weeks | 17.2 ml/min/kg | Standard Deviation 3 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | Baseline | 16.5 ml/min/kg | Standard Deviation 3.8 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | 24-weeks | 16.5 ml/min/kg | Standard Deviation 2.2 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | Baseline | 18.9 ml/min/kg | Standard Deviation 3.6 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | 24-weeks | 21.8 ml/min/kg | Standard Deviation 3.4 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | 12-weeks | 18.9 ml/min/kg | Standard Deviation 4.7 |
Comparison: Evaluate within group across time.p-value: 0.98ANOVA
Comparison: Evaluate within group across time.p-value: 0.99ANOVA
Comparison: Evaluate within group across time.p-value: 0.87ANOVA
Comparison: Evaluate within group across time.p-value: 0.95ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.39ANOVA
Comparison: Comparison across groups at 12-wks.p-value: 0.59ANOVA
Comparison: Comparison across groups at 24-wks.p-value: 0.29ANOVA
Secondary
Symptom-Limited TMT Maximum Systolic Blood Pressure
Peak systolic BP achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Time frame: Baseline, 12-wk, 24-wk
Population: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | Baseline | 190.5 mmHg | Standard Deviation 26.5 |
| Sedentary Control Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | 24-weeks | 179.1 mmHg | Standard Deviation 13.9 |
| Sedentary Control Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | 12-weeks | 196.0 mmHg | Standard Deviation 19.8 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | Baseline | 189.3 mmHg | Standard Deviation 26.7 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | 24-weeks | 180.7 mmHg | Standard Deviation 20.6 |
| Aerobic Exercise Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | 12-weeks | 185.8 mmHg | Standard Deviation 17.8 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | 12-weeks | 200.0 mmHg | Standard Deviation 28.6 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | Baseline | 196.3 mmHg | Standard Deviation 25.5 |
| Strength Exercise Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | 24-weeks | 193.1 mmHg | Standard Deviation 21.4 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | Baseline | 188.4 mmHg | Standard Deviation 20.4 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | 24-weeks | 185.3 mmHg | Standard Deviation 9.9 |
| Combined Aerobic and Strength Exercise Group | Symptom-Limited TMT Maximum Systolic Blood Pressure | 12-weeks | 184.0 mmHg | Standard Deviation 29.8 |
Comparison: Evaluate within group across time.p-value: 0.84ANOVA
Comparison: Evaluate within group across time.p-value: 0.93ANOVA
Comparison: Evaluate within group across time.p-value: 0.94ANOVA
Comparison: Evaluate within group across time.p-value: 0.94ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.88ANOVA
Comparison: Comparison across groups at 12 wks.p-value: 0.48ANOVA
Comparison: Comparison across groups at 24 wks.p-value: 0.38ANOVA
Secondary
Voluntary Duration of Symptom-Limited TMT
Total time subjects voluntarily exercised while undergoing a modified Bruce Protocol treadmill test (TMT)
Time frame: baseline, 12-wks, 24-wks
Population: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Voluntary Duration of Symptom-Limited TMT | 24-weeks | 11.4 minutes | Standard Deviation 3.9 |
| Sedentary Control Group | Voluntary Duration of Symptom-Limited TMT | 12-weeks | 10.7 minutes | Standard Deviation 3.8 |
| Sedentary Control Group | Voluntary Duration of Symptom-Limited TMT | Baseline | 10.8 minutes | Standard Deviation 3.5 |
| Aerobic Exercise Group | Voluntary Duration of Symptom-Limited TMT | 24-weeks | 13.3 minutes | Standard Deviation 2.9 |
| Aerobic Exercise Group | Voluntary Duration of Symptom-Limited TMT | 12-weeks | 13.4 minutes | Standard Deviation 2.5 |
| Aerobic Exercise Group | Voluntary Duration of Symptom-Limited TMT | Baseline | 11.9 minutes | Standard Deviation 2.2 |
| Strength Exercise Group | Voluntary Duration of Symptom-Limited TMT | Baseline | 8.8 minutes | Standard Deviation 2.9 |
| Strength Exercise Group | Voluntary Duration of Symptom-Limited TMT | 12-weeks | 9.3 minutes | Standard Deviation 3 |
| Strength Exercise Group | Voluntary Duration of Symptom-Limited TMT | 24-weeks | 9.0 minutes | Standard Deviation 2.9 |
| Combined Aerobic and Strength Exercise Group | Voluntary Duration of Symptom-Limited TMT | 24-weeks | 14.2 minutes | Standard Deviation 2.8 |
| Combined Aerobic and Strength Exercise Group | Voluntary Duration of Symptom-Limited TMT | 12-weeks | 13.0 minutes | Standard Deviation 4.4 |
| Combined Aerobic and Strength Exercise Group | Voluntary Duration of Symptom-Limited TMT | Baseline | 11.0 minutes | Standard Deviation 3.5 |
Comparison: Evaluate within group across time.p-value: 1ANOVA
Comparison: Evaluate within group across time.p-value: 0.36ANOVA
Comparison: Evaluate within group across time.p-value: 0.93ANOVA
Comparison: Evaluate within group across time.p-value: 0.46ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.14ANOVA
Comparison: Comparison across groups at 12 wks.p-value: 0.05ANOVA
Comparison: Comparison across groups at 24 wks.p-value: 0.01ANOVA
Other Pre-specified
Age
Age of participants at entry into study.
Time frame: at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Control Group | Age | 61.0 years | Standard Deviation 7 |
| Aerobic Exercise Group | Age | 61.9 years | Standard Deviation 8.3 |
| Strength Exercise Group | Age | 64.2 years | Standard Deviation 9.5 |
| Combined Aerobic and Strength Exercise Group | Age | 63.0 years | Standard Deviation 6.6 |
Comparison: Comparison across groups at baseline.p-value: 0.79ANOVA
Other Pre-specified
Aspartate Aminotransferase Laboratory Values
Laboratory values for Aspartate Aminotransferase (AST) at baseline entry into study
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Control Group | Aspartate Aminotransferase Laboratory Values | 20.8 units/L | Standard Deviation 5.6 |
| Aerobic Exercise Group | Aspartate Aminotransferase Laboratory Values | 13.5 units/L | Standard Deviation 6.3 |
| Strength Exercise Group | Aspartate Aminotransferase Laboratory Values | 19.5 units/L | Standard Deviation 9.6 |
| Combined Aerobic and Strength Exercise Group | Aspartate Aminotransferase Laboratory Values | 23.6 units/L | Standard Deviation 15.2 |
Comparison: Comparison across groups at baseline.p-value: 0.12ANOVA
Other Pre-specified
Blood Urea Nitrogen (BUN) Laboratory Values
Laboratory Blood Urea Nitrogen levels at baseline entry into study
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Control Group | Blood Urea Nitrogen (BUN) Laboratory Values | 17.0 mg/dL | Standard Deviation 5.5 |
| Aerobic Exercise Group | Blood Urea Nitrogen (BUN) Laboratory Values | 19.0 mg/dL | Standard Deviation 5.9 |
| Strength Exercise Group | Blood Urea Nitrogen (BUN) Laboratory Values | 16.5 mg/dL | Standard Deviation 6.7 |
| Combined Aerobic and Strength Exercise Group | Blood Urea Nitrogen (BUN) Laboratory Values | 17.8 mg/dL | Standard Deviation 5.6 |
Comparison: Comparison across groups at baseline.p-value: 0.77ANOVA
Other Pre-specified
Body Mass Index (BMI)
BMI is calculated as a ratio of subject body mass (kg) divided by the square of subject height (m).
Time frame: Baseline, 12-wk, 24-wk
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 2) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 8 at 6 month evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Body Mass Index (BMI) | 24-wk | 31.5 kg/m^2 | Standard Deviation 2.6 |
| Sedentary Control Group | Body Mass Index (BMI) | 12-wk | 32.3 kg/m^2 | Standard Deviation 2.8 |
| Sedentary Control Group | Body Mass Index (BMI) | Baseline | 32.9 kg/m^2 | Standard Deviation 3.5 |
| Aerobic Exercise Group | Body Mass Index (BMI) | 12-wk | 33.4 kg/m^2 | Standard Deviation 5 |
| Aerobic Exercise Group | Body Mass Index (BMI) | 24-wk | 33.4 kg/m^2 | Standard Deviation 4.9 |
| Aerobic Exercise Group | Body Mass Index (BMI) | Baseline | 33.4 kg/m^2 | Standard Deviation 5.4 |
| Strength Exercise Group | Body Mass Index (BMI) | 12-wk | 31.6 kg/m^2 | Standard Deviation 4.2 |
| Strength Exercise Group | Body Mass Index (BMI) | Baseline | 31.5 kg/m^2 | Standard Deviation 4.1 |
| Strength Exercise Group | Body Mass Index (BMI) | 24-wk | 31.9 kg/m^2 | Standard Deviation 4.3 |
| Combined Aerobic and Strength Exercise Group | Body Mass Index (BMI) | 24-wk | 31.5 kg/m^2 | Standard Deviation 3.8 |
| Combined Aerobic and Strength Exercise Group | Body Mass Index (BMI) | 12-wk | 30.8 kg/m^2 | Standard Deviation 4 |
| Combined Aerobic and Strength Exercise Group | Body Mass Index (BMI) | Baseline | 32.4 kg/m^2 | Standard Deviation 6.3 |
Comparison: Evaluate within group across time.p-value: 0.88ANOVA
Comparison: Evaluate within group across time.p-value: 1ANOVA
Comparison: Evaluate within group across time.p-value: 1ANOVA
Comparison: Evaluate within group across time.p-value: 0.76ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.82ANOVA
Comparison: Comparison across groups at 12 wks.p-value: 0.53ANOVA
Comparison: Comparison across groups at 24 wks.p-value: 0.68ANOVA
Other Pre-specified
Cholesterol Laboratory Values
Laboratory total cholesterol, HDL-cholesterol, and LDL-cholesterol levels at baseline entry into study
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Cholesterol Laboratory Values | Total Cholesterol | 139.3 mg/dL | Standard Deviation 25.1 |
| Sedentary Control Group | Cholesterol Laboratory Values | LDL-Cholesterol | 68.4 mg/dL | Standard Deviation 23.3 |
| Sedentary Control Group | Cholesterol Laboratory Values | HDL-Cholesterol | 41.4 mg/dL | Standard Deviation 29 |
| Aerobic Exercise Group | Cholesterol Laboratory Values | Total Cholesterol | 156.4 mg/dL | Standard Deviation 36.2 |
| Aerobic Exercise Group | Cholesterol Laboratory Values | LDL-Cholesterol | 88.6 mg/dL | Standard Deviation 31.2 |
| Aerobic Exercise Group | Cholesterol Laboratory Values | HDL-Cholesterol | 42.8 mg/dL | Standard Deviation 13.5 |
| Strength Exercise Group | Cholesterol Laboratory Values | HDL-Cholesterol | 40.7 mg/dL | Standard Deviation 14 |
| Strength Exercise Group | Cholesterol Laboratory Values | Total Cholesterol | 158.5 mg/dL | Standard Deviation 39.7 |
| Strength Exercise Group | Cholesterol Laboratory Values | LDL-Cholesterol | 89.0 mg/dL | Standard Deviation 42.5 |
| Combined Aerobic and Strength Exercise Group | Cholesterol Laboratory Values | Total Cholesterol | 159.9 mg/dL | Standard Deviation 48.7 |
| Combined Aerobic and Strength Exercise Group | Cholesterol Laboratory Values | LDL-Cholesterol | 89.2 mg/dL | Standard Deviation 48 |
| Combined Aerobic and Strength Exercise Group | Cholesterol Laboratory Values | HDL-Cholesterol | 38.4 mg/dL | Standard Deviation 4.8 |
Comparison: Comparison across groups at baseline.p-value: 0.45ANOVA
Other Pre-specified
Creatinine Laboratory Values
Laboratory creatinine values at baseline entry into study
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Control Group | Creatinine Laboratory Values | 1.1 mg/dL | Standard Deviation 0.2 |
| Aerobic Exercise Group | Creatinine Laboratory Values | 1.0 mg/dL | Standard Deviation 0.1 |
| Strength Exercise Group | Creatinine Laboratory Values | 0.9 mg/dL | Standard Deviation 0.1 |
| Combined Aerobic and Strength Exercise Group | Creatinine Laboratory Values | 1.0 mg/dL | Standard Deviation 0.2 |
Comparison: Comparison across groups at baseline.p-value: 0.04ANOVA
Other Pre-specified
Duration of Diabetes Mellitus
Duration, in years, since first diagnosed with Diabetes Mellitus upon entry into study
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Control Group | Duration of Diabetes Mellitus | 12.6 years | Standard Deviation 11.1 |
| Aerobic Exercise Group | Duration of Diabetes Mellitus | 10.9 years | Standard Deviation 4.1 |
| Strength Exercise Group | Duration of Diabetes Mellitus | 10.1 years | Standard Deviation 6.7 |
| Combined Aerobic and Strength Exercise Group | Duration of Diabetes Mellitus | 8.9 years | Standard Deviation 6.3 |
Comparison: Comparison across groups at baseline.p-value: 0.7ANOVA
Other Pre-specified
HbA1C Laboratory Values
Laboratory values of subject HbA1C levels at Baseline, 12-wk, 24-wk
Time frame: Baseline, 12-wk, 24-wk
Population: A1c testing was performed prior to EMG evaluation so there are 2/4 additional values for 3/6 month numbers of subjects than is reflected in the statement regarding subject withdrawal in the EMG sections. Total difference = 6 at 6 month evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | HbA1C Laboratory Values | Baseline | 7.8 percentage of Hb | Standard Deviation 0.5 |
| Sedentary Control Group | HbA1C Laboratory Values | 24-wk | 7.2 percentage of Hb | Standard Deviation 1.1 |
| Sedentary Control Group | HbA1C Laboratory Values | 12-wk | 7.7 percentage of Hb | Standard Deviation 1 |
| Aerobic Exercise Group | HbA1C Laboratory Values | Baseline | 8.0 percentage of Hb | Standard Deviation 1 |
| Aerobic Exercise Group | HbA1C Laboratory Values | 24-wk | 7.9 percentage of Hb | Standard Deviation 1.3 |
| Aerobic Exercise Group | HbA1C Laboratory Values | 12-wk | 8.0 percentage of Hb | Standard Deviation 1.5 |
| Strength Exercise Group | HbA1C Laboratory Values | 12-wk | 7.4 percentage of Hb | Standard Deviation 1 |
| Strength Exercise Group | HbA1C Laboratory Values | Baseline | 8.0 percentage of Hb | Standard Deviation 1 |
| Strength Exercise Group | HbA1C Laboratory Values | 24-wk | 8.0 percentage of Hb | Standard Deviation 1.2 |
| Combined Aerobic and Strength Exercise Group | HbA1C Laboratory Values | Baseline | 7.2 percentage of Hb | Standard Deviation 0.7 |
| Combined Aerobic and Strength Exercise Group | HbA1C Laboratory Values | 24-wk | 7.1 percentage of Hb | Standard Deviation 0.7 |
| Combined Aerobic and Strength Exercise Group | HbA1C Laboratory Values | 12-wk | 7.3 percentage of Hb | Standard Deviation 1 |
Other Pre-specified
Height
Height of subjects upon entry into study
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Control Group | Height | 178.1 cm | Standard Deviation 5.8 |
| Aerobic Exercise Group | Height | 181.0 cm | Standard Deviation 8.6 |
| Strength Exercise Group | Height | 179.9 cm | Standard Deviation 5.3 |
| Combined Aerobic and Strength Exercise Group | Height | 177.4 cm | Standard Deviation 7.1 |
Comparison: Comparison across groups at baseline.p-value: 0.59ANOVA
Other Pre-specified
Thyroid Stimulating Hormone Laboratory Values
Laboratory values for Thyroid Stimulating Hormone (TSH) at baseline entry into study
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Control Group | Thyroid Stimulating Hormone Laboratory Values | 1.3 uIU/mL | Standard Deviation 0.6 |
| Aerobic Exercise Group | Thyroid Stimulating Hormone Laboratory Values | 1.8 uIU/mL | Standard Deviation 0.9 |
| Strength Exercise Group | Thyroid Stimulating Hormone Laboratory Values | 2.0 uIU/mL | Standard Deviation 1.6 |
| Combined Aerobic and Strength Exercise Group | Thyroid Stimulating Hormone Laboratory Values | 1.8 uIU/mL | Standard Deviation 0.7 |
Comparison: Comparison across groups at baseline.p-value: 0.42ANOVA
Other Pre-specified
Triglyceride Laboratory Values
Laboratory triglyceride values at baseline entry into study
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Control Group | Triglyceride Laboratory Values | 157.7 mg/dL | Standard Deviation 84.5 |
| Aerobic Exercise Group | Triglyceride Laboratory Values | 125.0 mg/dL | Standard Deviation 57.1 |
| Strength Exercise Group | Triglyceride Laboratory Values | 144.5 mg/dL | Standard Deviation 68.2 |
| Combined Aerobic and Strength Exercise Group | Triglyceride Laboratory Values | 162.0 mg/dL | Standard Deviation 60 |
Comparison: Comparison across groups at baseline.p-value: 0.59ANOVA
Other Pre-specified
Weight
Weight of subjects at baseline, 12-weeks, and 24-weeks
Time frame: Baseline, 12-wks, 24-wks
Population: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 2) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 8 at 6 month evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Control Group | Weight | 24-wks | 100.5 kg | Standard Deviation 10.5 |
| Sedentary Control Group | Weight | 12-wks | 103.7 kg | Standard Deviation 12.9 |
| Sedentary Control Group | Weight | Baseline | 104.7 kg | Standard Deviation 14.4 |
| Aerobic Exercise Group | Weight | 24-wks | 109.8 kg | Standard Deviation 18.3 |
| Aerobic Exercise Group | Weight | 12-wks | 109.8 kg | Standard Deviation 18.5 |
| Aerobic Exercise Group | Weight | Baseline | 109.9 kg | Standard Deviation 19.7 |
| Strength Exercise Group | Weight | Baseline | 102.6 kg | Standard Deviation 16.3 |
| Strength Exercise Group | Weight | 12-wks | 102.9 kg | Standard Deviation 17 |
| Strength Exercise Group | Weight | 24-wks | 103.8 kg | Standard Deviation 17.6 |
| Combined Aerobic and Strength Exercise Group | Weight | 24-wks | 98.4 kg | Standard Deviation 10.7 |
| Combined Aerobic and Strength Exercise Group | Weight | 12-wks | 97.1 kg | Standard Deviation 9.7 |
| Combined Aerobic and Strength Exercise Group | Weight | Baseline | 101.3 kg | Standard Deviation 14.4 |
Comparison: Evaluate within group across time.p-value: 0.98ANOVA
Comparison: Evaluate within group across time.p-value: 1ANOVA
Comparison: Evaluate within group across time.p-value: 1ANOVA
Comparison: Evaluate within group across time.p-value: 0.72ANOVA
Comparison: Comparison across groups at baseline.p-value: 0.62ANOVA
Comparison: Comparison across groups at 12 wks.p-value: 0.33ANOVA
Comparison: Comparison across groups at 24 wks.p-value: 0.38ANOVA