Insulin Resistance, Obesity, Sedentary Lifestyle
Conditions
Keywords
exercise, insulin resistance, mitochondrial function, arterial stiffness, exercise intensity, fitness
Brief summary
African Americans are at a substantially greater type 2 diabetes risk compared to Caucasians; however, very little data are available on the effects of exercise training on type 2 diabetes risk factors in at risk African Americans. The present proposal will evaluate the effects of 6 months of moderate versus vigorous intensity aerobic exercise training on fitness, insulin sensitivity, mitochondrial capacity, skeletal muscle oxidative/insulin sensitivity markers, adiposity, and quality of life in African Americans.
Detailed description
African Americans have a much greater risk of type 2 diabetes compared to Caucasians in the United States. Similarly, recent evidence has emerged that fitness level, a major risk factor for type 2 diabetes also tends to be lower in African Americans. Many scientific studies have shown that exercise training has a beneficial impact on fitness levels and a variety of other type 2 diabetes risk factors such as the reduction of glucose/insulin levels, and body fat Importantly, studies performed in mostly Caucasian populations suggest that exercise training at a vigorous intensity may promote greater improvements in type 2 diabetes risk factors compared to moderate intensity exercise, which may suggest that it has greater promise in reducing type 2 diabetes risk. However, few exercise training studies compare the health benefits of different exercise training programs (such as exercise intensity) in African Americans, which is clinically important due to their greater type 2 diabetes risk, and that fact that they are less likely to meet public health recommendations for physical activity compared to their Caucasian counterparts. The High Intensity exercise to Promote Accelerated improvements in CardiorEspiratory fitness (HI-PACE) study will evaluate the effect of exercise intensity on cardiorespiratory fitness (CRF) and insulin sensitivity in obese (BMI: 30-45) African Americans (40-65 yrs.) with at least 1 additional T2D risk factor. Participants (n=60) will be recruited in collaboration with the ECU Center for Health Disparities, and subsequently randomized to moderate intensity (MOD-INT, n=20) or high intensity (HIGH-INT, n=20) aerobic exercise training, or to a control group (CON, n=20) for 24 weeks. Supervised exercise training will be performed at a heart rate associated with \ 50% and \ 75% of VO2 max in the MOD-INT and the HIGH-INT groups, respectively at the same exercise volume of 600 MET-minutes per week (consistent with public health recommendations). The primary outcome is the change in CRF, which will be assessed at baseline, mid-intervention, and follow-up. Insulin sensitivity will be measured via an intravenous glucose tolerance test at baseline and follow-up. Other secondary measures include mitochondrial oxidative capacity using infrared and measurements on muscle biopsies (PGC-1α and other indices of mitochondrial content), the expression of a protein involved with insulin action (GLUT-4 expression) in skeletal muscle as well as systemic inflammation, adiposity, quality of life and exercise enjoyment measures.
Interventions
BEHAVIORALModerate intensity exercise training (MOD-INT)
Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
BEHAVIORALHigh Intensity exercise training (HI-INT)
Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
Sponsors
East Carolina University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* African American * Body mass index 30-45 kg/m2 * sedentary/low active (step count ≤ 6,500 step/day) * capable and willing to give written informed consent and understand
Exclusion criteria
* willingness to accept group assignment from randomization * No resistance training and no structured aerobic exercise for \> 20 minutes per day, 3+ days per week, for the last 6 months * conditions that are contraindicated for exercise training
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiorespiratory Fitness | Baseline and 24 weeks | Fitness will be measured using a modified Balke protocol on a treadmill. Participants will walk at an initial speed of 2.0 mph with 0% grade for the first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 3 minutes. The treadmill grade will be increased by 2.5% every 3 minutes until volitional exhaustion. Maximal oxygen consumption (Liters of O2 per minute) will be measured using a True Max 2400 Metabolic Measurement Cart (Parvomedics, Salt Lake City Utah). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline and 24 weeks | Weight will be measured using a calibrated scale. Weight will be measured in kg |
| Change in Waist Circumference | Baseline and 24 weeks | Waist circumference will be measured at the natural waist (midway between the inferior border of the rib cage and the superior aspect of the iliac crest) with a Gulick tape measure. Both landmarks (the inferior border of the ribcage and the superior aspect of the iliac crest) will be marked and the distance will be measured to determine the appropriate measurement site. Staff will confirm that: 1) the measurement tape remains horizontal; 2) the tape touches the entire circumference of the participant; 3) abdominal tissue is not compressed; 3) the tape measure is not within abdominal folds; 4) the measurement is taken at the end of normal respiration. The measurement will be repeated an additional time, and the reported value will be the average of these measurements. Both measurements must be within 0.5 cm to be considered acceptable for data purposes. |
| Change in Low Density Lipoprotein | Baseline and 24 Weeks | Low density lipoprotein will be measured from a fasting blood sample |
| Change in High Density Lipoprotein | Baseline and 24 Weeks | High density lipoprotein will be measured from a fasted blood sample |
| Changes in Total Cholesterol | Baseline and 24 weeks | Total Cholesterol will be measured in a fasting blood sample |
| Change in Triglycerides | Baseline and 24 Weeks | Triglyceride levels will be measured from a fasting blood sample |
| Change in Systemic Inflammation | Baseline and 24 weeks | High sensitivity c-reactive protein will be measured at baseline and follow-up |
| Change in Fasting Glucose | Baseline and 24 Weeks | Fasting glucose will be measured from a fasting blood sample |
| Change in Body Fat Percentage | Baseline and 24 weeks | Dual-energy X-ray absorptiometry will be used to measure changes in body fat percentage |
| Change in Insulin Sensitivity | Baseline and 24 weeks | Insulin sensitivity will be measured using an intravenous glucose tolerance test |
| Change in Arterial Stiffness | Baseline and 24 weeks | Arterial stiffness will be measured using pulse wave velocity. |
| Change in Mitochondrial Enzymes | Baseline and 24 weeks | Mitochondrial enzymes (citrate synthase, pgc1aplha and complex1-5) |
| Change in Quality of Life | Baseline and 24 weeks | Quality of life (QOL) will be measured by the short form health survey (SF-36). SF36 consists of 36 questions that measure patient's HRQoL in 8 domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) that represent the physical HRQoL, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH) that represent the mental HRQoL. Each domain is scored from 0 (worst health status) to 100 (best health status). |
| Change in Quality of Life (Mental Health and Physical Health Summary Scores) | Baseline to 24 Weeks | The SF-36 also produces a measure of overall physical health (physical component score \[PCS\]) and overall mental health (mental component score \[MCS\]). Scoring of these items are standardized using means and standard deviations from the general US population. Aggregate PCS and MCS scores are standardized using a linear T-Score transformation to have a mean of 50 and a standard deviation of 10. A higher score indicates better quality of life and a lower score indicates worsened quality of life. |
| Changes in Physical Activity Levels | Baseline and 24 Weeks | Participants will wear an ActivPal accelerometer for seven consecutive days, 24-hrs/day. The change in steps will be be evaluated from baseline to 24 weeks |
| Change in Dietary Composition | Baseline and 24 weeks | Food Frequency Questionnaire (FFQ) contains approximately 105 items grouped by categories and is completed for both frequency of consumption as well as portion size selections by the individual. The questionnaire, upon completion, provides estimated daily intake values for selected nutrients (kilocalories, macronutrients, and micronutrients) and provides information on food group servings. |
| Change in Insulin | Baseline and 24 Weeks | Fasting insulin value will be measured from a blood sample |
Countries
United States
Participant flow
Recruitment details
The HI-PACE study was conducted in Greenville, NC at East Carolina University. Participants were recruited from the local Greenville, NC and Pitt County areas. Methods of recruitment included sending information to mailing list of local agencies, working with community partners, the ECU health disparity center, social media advertisements and local newspaper advertisements. Recruitment for the study began in Fall of 2016
Pre-assignment details
individuals interested in study participation came in for a screening visit to determine initial eligibility. After this, those that remained eligible, did a run-in period where they wore an accelerometer for 7 consecutive days. When they returned with their accelerometer, a blood draw was performed for screening labs. After this, participants were scheduled for primary and secondary outcome measures. After completion of these outcomes measures, they were randomized to study groups.
Participants by arm
| Arm | Count |
|---|---|
| Control (CON) This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete | 18 |
| Moderate Intensity (MOD-INT) The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes) | 16 |
| High Intensity Exercise (HIGH-INT) High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3 | 18 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Blood pressure was too elevated | 0 | 1 | 0 |
| Overall Study | Corona virus pandemic | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | participant did not disclose she had an excluded medical condition and was disenrolled | 0 | 1 | 0 |
| Overall Study | Sick family member | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Control (CON) | Moderate Intensity (MOD-INT) | High Intensity Exercise (HIGH-INT) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 16 Participants | 18 Participants | 52 Participants |
| Age, Continuous | 49.8 years STANDARD_DEVIATION 7.1 | 50.2 years STANDARD_DEVIATION 7.6 | 48.0 years STANDARD_DEVIATION 8 | 49.3 years STANDARD_DEVIATION 7.5 |
| Body mass index | 32.9 kg/m^2 STANDARD_DEVIATION 6.2 | 35.6 kg/m^2 STANDARD_DEVIATION 4.8 | 36.8 kg/m^2 STANDARD_DEVIATION 5.8 | 35.1 kg/m^2 STANDARD_DEVIATION 5.8 |
| Cardiorespiratory fitness (L/min) | 2.0 L/min STANDARD_DEVIATION 0.6 | 1.8 L/min STANDARD_DEVIATION 0.4 | 2.0 L/min STANDARD_DEVIATION 0.6 | 1.9 L/min STANDARD_DEVIATION 0.5 |
| Cardiorespiratory fitness (mL/kg/min) | 21.6 mL/kg/min STANDARD_DEVIATION 6 | 18.5 mL/kg/min STANDARD_DEVIATION 4.3 | 18.7 mL/kg/min STANDARD_DEVIATION 3.8 | 19.5 mL/kg/min STANDARD_DEVIATION 4.9 |
| C-reactive protein | 5.5 mg/L STANDARD_DEVIATION 4.4 | 5.6 mg/L STANDARD_DEVIATION 4.9 | 6.1 mg/L STANDARD_DEVIATION 7.8 | 5.7 mg/L STANDARD_DEVIATION 5.9 |
| Diastolic blood pressure | 81.8 mmHg STANDARD_DEVIATION 10.9 | 83.1 mmHg STANDARD_DEVIATION 9.6 | 85.1 mmHg STANDARD_DEVIATION 8.8 | 83.3 mmHg STANDARD_DEVIATION 9.7 |
| Glucose | 93.3 mg/dL STANDARD_DEVIATION 10.5 | 93.2 mg/dL STANDARD_DEVIATION 6.9 | 94.5 mg/dL STANDARD_DEVIATION 11.6 | 93.7 mg/dL STANDARD_DEVIATION 9.9 |
| High density lipoprotein | 54.7 mg/dL STANDARD_DEVIATION 15.6 | 53.9 mg/dL STANDARD_DEVIATION 13.6 | 48.3 mg/dL STANDARD_DEVIATION 14.3 | 52.2 mg/dL STANDARD_DEVIATION 14.6 |
| Insulin | 13.6 ulU/mL STANDARD_DEVIATION 8 | 15.4 ulU/mL STANDARD_DEVIATION 9.3 | 16.4 ulU/mL STANDARD_DEVIATION 8.2 | 15.1 ulU/mL STANDARD_DEVIATION 8.4 |
| Low density lipoprotein | 111.3 mg/dL STANDARD_DEVIATION 27.5 | 107.3 mg/dL STANDARD_DEVIATION 40.5 | 98.4 mg/dL STANDARD_DEVIATION 28.8 | 105.6 mg/dL STANDARD_DEVIATION 32.1 |
| Pulse wave velocity | 7.4 m/sec STANDARD_DEVIATION 1.1 | 6.9 m/sec STANDARD_DEVIATION 1.3 | 7.6 m/sec STANDARD_DEVIATION 1.2 | 7.3 m/sec STANDARD_DEVIATION 1.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 16 Participants | 18 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 18 participants | 16 participants | 18 participants | 52 participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 16 Participants | 43 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 2 Participants | 9 Participants |
| Systolic blood pressure | 128.5 mmHg STANDARD_DEVIATION 13.6 | 129.8 mmHg STANDARD_DEVIATION 10.8 | 133.9 mmHg STANDARD_DEVIATION 12.6 | 130.8 mmHg STANDARD_DEVIATION 12.6 |
| Total cholesterol | 185.6 mg/dL STANDARD_DEVIATION 26.7 | 177.3 mg/dL STANDARD_DEVIATION 40.5 | 166.4 mg/dL STANDARD_DEVIATION 33.2 | 176.4 mg/dL STANDARD_DEVIATION 33.8 |
| Triglycerides | 97.7 mg/dL STANDARD_DEVIATION 46.1 | 80.0 mg/dL STANDARD_DEVIATION 23.2 | 98.1 mg/dL STANDARD_DEVIATION 40.2 | 92.6 mg/dL STANDARD_DEVIATION 38.6 |
| Weight | 90.7 kg STANDARD_DEVIATION 17 | 98.7 kg STANDARD_DEVIATION 13.6 | 104.9 kg STANDARD_DEVIATION 20.7 | 98.1 kg STANDARD_DEVIATION 18.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 16 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 1 / 16 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 | 0 / 18 |
Outcome results
Primary
Change in Cardiorespiratory Fitness
Fitness will be measured using a modified Balke protocol on a treadmill. Participants will walk at an initial speed of 2.0 mph with 0% grade for the first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 3 minutes. The treadmill grade will be increased by 2.5% every 3 minutes until volitional exhaustion. Maximal oxygen consumption (Liters of O2 per minute) will be measured using a True Max 2400 Metabolic Measurement Cart (Parvomedics, Salt Lake City Utah).
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in Cardiorespiratory Fitness | -0.15 Liters of oxygen/min |
| Moderate Intensity Exercise (MOD-INT) | Change in Cardiorespiratory Fitness | 0.12 Liters of oxygen/min |
| High Intensity Exercise HIGH-INT | Change in Cardiorespiratory Fitness | 0.22 Liters of oxygen/min |
Comparison: Comparison between the CON and the HIGH-INT groupp-value: 0.006ANCOVA
Comparison: Comparison between the CON and MOD-INT groupp-value: 0.045ANCOVA
Comparison: Comparison between MOD-INT and High-INT groupsp-value: 0.449ANCOVA
Secondary
Change in Arterial Stiffness
Arterial stiffness will be measured using pulse wave velocity.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in Arterial Stiffness | -0.21 m/sec |
| Moderate Intensity Exercise (MOD-INT) | Change in Arterial Stiffness | 0.68 m/sec |
| High Intensity Exercise HIGH-INT | Change in Arterial Stiffness | 0.47 m/sec |
Comparison: Comparison between the CON and HIGH-INT groupsp-value: 0.093ANCOVA
Comparison: Comparison between the CON and the MOD-INT groupsp-value: 0.033ANCOVA
Comparison: Comparison between the MOD-INT and HIGH-INT groupsp-value: 0.602ANCOVA
Secondary
Change in Body Fat Percentage
Dual-energy X-ray absorptiometry will be used to measure changes in body fat percentage
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in Body Fat Percentage | 0.09 percentage of body fat |
| Moderate Intensity Exercise (MOD-INT) | Change in Body Fat Percentage | -0.26 percentage of body fat |
| High Intensity Exercise HIGH-INT | Change in Body Fat Percentage | -0.71 percentage of body fat |
Comparison: Comparison between the CON and High-INT groupsp-value: 0.276ANCOVA
Comparison: Comparison between the CON and MOD-INT groupsp-value: 0.633ANCOVA
Comparison: Comparison between the MOD-INT and HIGH-INT groupsp-value: 0.555ANCOVA
Secondary
Change in Body Weight
Weight will be measured using a calibrated scale. Weight will be measured in kg
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in Body Weight | 0.87 kg |
| Moderate Intensity Exercise (MOD-INT) | Change in Body Weight | -0.37 kg |
| High Intensity Exercise HIGH-INT | Change in Body Weight | -0.42 kg |
Comparison: Comparison between the CON group and the HIGH-INT groupp-value: 0.37ANCOVA
Comparison: Comparison between the CON and the MOD-INT groupp-value: 0.383ANCOVA
Comparison: Comparison for the MOD-INT and HIGH-INT groupsp-value: 0.0972ANCOVA
Secondary
Change in Dietary Composition
Food Frequency Questionnaire (FFQ) contains approximately 105 items grouped by categories and is completed for both frequency of consumption as well as portion size selections by the individual. The questionnaire, upon completion, provides estimated daily intake values for selected nutrients (kilocalories, macronutrients, and micronutrients) and provides information on food group servings.
Time frame: Baseline and 24 weeks
Population: Error in processing the data and it was lost
Secondary
Change in Fasting Glucose
Fasting glucose will be measured from a fasting blood sample
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in Fasting Glucose | -2.81 mg/dL |
| Moderate Intensity Exercise (MOD-INT) | Change in Fasting Glucose | -2.5 mg/dL |
| High Intensity Exercise HIGH-INT | Change in Fasting Glucose | -2.0 mg/dL |
Comparison: Comparison of the CON and HIGH-INT groupsp-value: 0.769ANCOVA
Comparison: Comparison of the CON and MOD-INT groupsp-value: 0.8ANCOVA
p-value: 0.769ANCOVA
Secondary
Change in High Density Lipoprotein
High density lipoprotein will be measured from a fasted blood sample
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in High Density Lipoprotein | -3.4 mg/dL |
| Moderate Intensity Exercise (MOD-INT) | Change in High Density Lipoprotein | -1.1 mg/dL |
| High Intensity Exercise HIGH-INT | Change in High Density Lipoprotein | 1.3 mg/dL |
Comparison: Comparison between the CON and High-INT groupsp-value: 0.056ANCOVA
Comparison: Comparison between the CON and MOD-INT groupsp-value: 0.349ANCOVA
Comparison: Comparison between the MOD-INT and HIGH-INT groupsp-value: 0.359ANCOVA
Secondary
Change in Insulin
Fasting insulin value will be measured from a blood sample
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in Insulin | -2.68 ulU/mL |
| Moderate Intensity Exercise (MOD-INT) | Change in Insulin | -2.69 ulU/mL |
| High Intensity Exercise HIGH-INT | Change in Insulin | -2.7 ulU/mL |
Comparison: Comparison between the CON and the MOD groupsp-value: 1ANCOVA
Comparison: Comparison of HIGH-INT and CON groupsp-value: 0.993ANCOVA
Comparison: Comparison between the MOD-INT and the HIGH-INT groupsp-value: 0.994ANCOVA
Secondary
Change in Insulin Sensitivity
Insulin sensitivity will be measured using an intravenous glucose tolerance test
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in Insulin Sensitivity | 0.60 (mu/l)^-1.min^-1 |
| Moderate Intensity Exercise (MOD-INT) | Change in Insulin Sensitivity | 0.59 (mu/l)^-1.min^-1 |
| High Intensity Exercise HIGH-INT | Change in Insulin Sensitivity | 0.44 (mu/l)^-1.min^-1 |
Comparison: Change in insulin sensitivity (CON vs. HIGH-INT)p-value: 0.821ANCOVA
Comparison: Change in insulin sensitivity (CON vs. MOD-INT)p-value: 0.985ANCOVA
Comparison: Change in insulin sensitivity (MOD-INT vs. HIGH-INT)p-value: 0.856ANCOVA
Secondary
Change in Low Density Lipoprotein
Low density lipoprotein will be measured from a fasting blood sample
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in Low Density Lipoprotein | -7.1 mg/dL |
| Moderate Intensity Exercise (MOD-INT) | Change in Low Density Lipoprotein | -0.12 mg/dL |
| High Intensity Exercise HIGH-INT | Change in Low Density Lipoprotein | 2.3 mg/dL |
Comparison: Comparison between the CON and the HIGH-INT groupsp-value: 0.136ANCOVA
Comparison: Comparison between the CON and the MOD-INT groupp-value: 0.262ANCOVA
Comparison: Comparison between the MOD-INT group and the HIGH-INT groupsp-value: 0.715ANCOVA
Secondary
Change in Mitochondrial Enzymes
Mitochondrial enzymes (citrate synthase, pgc1aplha and complex1-5)
Time frame: Baseline and 24 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Control (CON) | Change in Mitochondrial Enzymes | Complex 5 | -0.05 U/mU |
| Control (CON) | Change in Mitochondrial Enzymes | Complex 4 | -0.32 U/mU |
| Control (CON) | Change in Mitochondrial Enzymes | Citrate synthase | -0.01 U/mU |
| Control (CON) | Change in Mitochondrial Enzymes | PGC1 alpha | -0.17 U/mU |
| Control (CON) | Change in Mitochondrial Enzymes | Complex 2 | -0.06 U/mU |
| Control (CON) | Change in Mitochondrial Enzymes | Complex 1 | -0.36 U/mU |
| Control (CON) | Change in Mitochondrial Enzymes | Complex 3 | 0.07 U/mU |
| Moderate Intensity Exercise (MOD-INT) | Change in Mitochondrial Enzymes | Complex 1 | 0.17 U/mU |
| Moderate Intensity Exercise (MOD-INT) | Change in Mitochondrial Enzymes | Complex 4 | 0.23 U/mU |
| Moderate Intensity Exercise (MOD-INT) | Change in Mitochondrial Enzymes | Complex 3 | 0.09 U/mU |
| Moderate Intensity Exercise (MOD-INT) | Change in Mitochondrial Enzymes | Complex 5 | 0.01 U/mU |
| Moderate Intensity Exercise (MOD-INT) | Change in Mitochondrial Enzymes | PGC1 alpha | 0.02 U/mU |
| Moderate Intensity Exercise (MOD-INT) | Change in Mitochondrial Enzymes | Complex 2 | 0.16 U/mU |
| Moderate Intensity Exercise (MOD-INT) | Change in Mitochondrial Enzymes | Citrate synthase | 0.02 U/mU |
| High Intensity Exercise HIGH-INT | Change in Mitochondrial Enzymes | Complex 5 | 0.01 U/mU |
| High Intensity Exercise HIGH-INT | Change in Mitochondrial Enzymes | Complex 2 | -0.05 U/mU |
| High Intensity Exercise HIGH-INT | Change in Mitochondrial Enzymes | PGC1 alpha | -0.02 U/mU |
| High Intensity Exercise HIGH-INT | Change in Mitochondrial Enzymes | Citrate synthase | 0.17 U/mU |
| High Intensity Exercise HIGH-INT | Change in Mitochondrial Enzymes | Complex 3 | -0.01 U/mU |
| High Intensity Exercise HIGH-INT | Change in Mitochondrial Enzymes | Complex 4 | 0.01 U/mU |
| High Intensity Exercise HIGH-INT | Change in Mitochondrial Enzymes | Complex 1 | -0.05 U/mU |
Comparison: Change in PGC1A (CON vs. HIGH-INT)p-value: 0.424ANCOVA
Comparison: Change in PGC1A (CON vs. MOD-INT)p-value: 0.308ANCOVA
Comparison: Change in PGC1a (MOD-INT vs. HIGH-INT)p-value: 0.844ANCOVA
Comparison: Change in citrate synthase (CON vs. HIGH-INT)p-value: 0.135ANCOVA
Comparison: Change in Citrate synthase (CON vs. MOD-INT)p-value: 0.8ANCOVA
Comparison: Change in citrate synthasep-value: 0.195ANCOVA
Comparison: Change in complex Ip-value: 0.459ANCOVA
Comparison: Change in complex 1 (CON vs. MOD-INT groups)p-value: 0.213ANCOVA
Comparison: Change in complex II (MOD-INT vs. HIGH-INT)p-value: 0.971ANCOVA
Comparison: Change in complex III (CON vs. HIGH-INT)p-value: 0.634ANCOVA
Comparison: Change in Complex III (CON vs. MOD-INT groups)p-value: 0.919ANCOVA
Comparison: Change in complex IIIp-value: 0.574ANCOVA
Comparison: Change in Complex IV (CON vs. HIGH-INT)p-value: 0.295ANCOVA
Comparison: Change in complex IV (CON vs. MOD-INT)p-value: 0.097ANCOVA
Comparison: Change in complex IVp-value: 0.468ANCOVA
Comparison: Change in complex Vp-value: 0.589ANCOVA
Comparison: Change in complex V (CON vs. MOD-INT)p-value: 0.196ANCOVA
Comparison: Change in Complex V (MOD-INT vs. HIGH-INT)p-value: 0.436ANCOVA
Secondary
Change in Quality of Life
Quality of life (QOL) will be measured by the short form health survey (SF-36). SF36 consists of 36 questions that measure patient's HRQoL in 8 domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) that represent the physical HRQoL, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH) that represent the mental HRQoL. Each domain is scored from 0 (worst health status) to 100 (best health status).
Time frame: Baseline and 24 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Control (CON) | Change in Quality of Life | Mental health | 0.8 score on a scale |
| Control (CON) | Change in Quality of Life | General Health | -1.6 score on a scale |
| Control (CON) | Change in Quality of Life | Physical health | -0.18 score on a scale |
| Control (CON) | Change in Quality of Life | Role Physical | -0.22 score on a scale |
| Control (CON) | Change in Quality of Life | Bodily pain | -3.6 score on a scale |
| Control (CON) | Change in Quality of Life | Vitality | 1.1 score on a scale |
| Control (CON) | Change in Quality of Life | Social Function | -0.15 score on a scale |
| Control (CON) | Change in Quality of Life | Role Emotional | 0.8 score on a scale |
| Moderate Intensity Exercise (MOD-INT) | Change in Quality of Life | Physical health | 0.57 score on a scale |
| Moderate Intensity Exercise (MOD-INT) | Change in Quality of Life | Social Function | -5.2 score on a scale |
| Moderate Intensity Exercise (MOD-INT) | Change in Quality of Life | Role Physical | -1.2 score on a scale |
| Moderate Intensity Exercise (MOD-INT) | Change in Quality of Life | Bodily pain | -2.1 score on a scale |
| Moderate Intensity Exercise (MOD-INT) | Change in Quality of Life | Vitality | -1.51 score on a scale |
| Moderate Intensity Exercise (MOD-INT) | Change in Quality of Life | Mental health | -2.2 score on a scale |
| Moderate Intensity Exercise (MOD-INT) | Change in Quality of Life | General Health | 1.3 score on a scale |
| Moderate Intensity Exercise (MOD-INT) | Change in Quality of Life | Role Emotional | -0.0 score on a scale |
| High Intensity Exercise HIGH-INT | Change in Quality of Life | Physical health | 2.4 score on a scale |
| High Intensity Exercise HIGH-INT | Change in Quality of Life | General Health | -1.0 score on a scale |
| High Intensity Exercise HIGH-INT | Change in Quality of Life | Mental health | 0.65 score on a scale |
| High Intensity Exercise HIGH-INT | Change in Quality of Life | Role Physical | 1.1 score on a scale |
| High Intensity Exercise HIGH-INT | Change in Quality of Life | Social Function | 0.7 score on a scale |
| High Intensity Exercise HIGH-INT | Change in Quality of Life | Vitality | 2.6 score on a scale |
| High Intensity Exercise HIGH-INT | Change in Quality of Life | Bodily pain | 0.2 score on a scale |
| High Intensity Exercise HIGH-INT | Change in Quality of Life | Role Emotional | 2.3 score on a scale |
Comparison: Vitality sub-scale (CON vs. MOD-INT group)p-value: 0.203ANCOVA
Comparison: Comparison of general health subscale (CON vs. HIGH INT)p-value: 0.756ANCOVA
Comparison: General Health Subscale (CON vs. MOD-INT)p-value: 0.115ANCOVA
Comparison: General Health Subscale (MOD-INT vs. HIGH-INT)p-value: 0.225ANCOVA
Comparison: Physical health Sub-scale (CON vs. HIGH-INT)p-value: 0.758ANCOVA
Comparison: Physical health subscale (CON vs. MOD-INT)p-value: 0.759ANCOVA
Comparison: Physical Health subscale (MOD-INT vs. HIGH-INT)p-value: 0.465ANCOVA
Comparison: Role Physical subscale (CON vs. HIGH-INT)p-value: 0.549ANCOVA
Comparison: Role Physical Subscale (CON vs. MOD-INT)p-value: 0.679ANCOVA
Comparison: Role Physical Subscale (MOD-INT vs. HIGH-INT)p-value: 0.334ANCOVA
Comparison: Bodily pain subscale (CON vs. HIGH-INT)p-value: 0.273ANCOVA
Comparison: Bodily pain subscale (CON vs. MOD-INT)p-value: 0.642ANCOVA
Comparison: Bodily Pain Subscale (MOD-INT vs. HIGH-INT)p-value: 0.52ANCOVA
Comparison: Vitality subscale (CON vs. HIGH-INT)p-value: 0.46ANCOVA
Comparison: Vitality subscale (MOD-INT vs. HIGH-INT)p-value: 0.058ANCOVA
Comparison: Social Function subscale (CON vs. HIGH-INT)p-value: 0.739ANCOVA
Comparison: Social Function subscale (CON vs. MOD-INT)p-value: 0.059ANCOVA
Comparison: Social Function sub-scale (HIGH-INT vs. MOD-INT)p-value: 0.038ANCOVA
Comparison: Comparison of mental health subscale (CON vs. HIGH-INT)p-value: 0.95ANCOVA
Comparison: Change in mental health subscale (CON Vs. MOD INT)p-value: 0.096ANCOVA
Comparison: Change in mental health subscale (MOD-INT vs. HIGH-INT)p-value: 0.127ANCOVA
Comparison: Change in role emotional subscale (CON vs HIGH-INT)p-value: 0.373ANCOVA
Comparison: Change in role emotional sub-scalep-value: 0.63ANCOVA
Comparison: Change in role emotional subscale (MOD vs. HIGH-INT)p-value: 0.034ANCOVA
Comparison: Change in role emotional subscale (CON vs. MOD-INT)p-value: 0.07ANCOVA
Comparison: Change in physical health sub-scale (MOD-INT vs. HIGH-INT)p-value: 0.945ANCOVA
Secondary
Change in Quality of Life (Mental Health and Physical Health Summary Scores)
The SF-36 also produces a measure of overall physical health (physical component score \[PCS\]) and overall mental health (mental component score \[MCS\]). Scoring of these items are standardized using means and standard deviations from the general US population. Aggregate PCS and MCS scores are standardized using a linear T-Score transformation to have a mean of 50 and a standard deviation of 10. A higher score indicates better quality of life and a lower score indicates worsened quality of life.
Time frame: Baseline to 24 Weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Control (CON) | Change in Quality of Life (Mental Health and Physical Health Summary Scores) | Mental health (sum) | 0.75 score on a scale |
| Control (CON) | Change in Quality of Life (Mental Health and Physical Health Summary Scores) | Physical health (sum) | -2.02 score on a scale |
| Moderate Intensity Exercise (MOD-INT) | Change in Quality of Life (Mental Health and Physical Health Summary Scores) | Mental health (sum) | -2.7 score on a scale |
| Moderate Intensity Exercise (MOD-INT) | Change in Quality of Life (Mental Health and Physical Health Summary Scores) | Physical health (sum) | 0.02 score on a scale |
| High Intensity Exercise HIGH-INT | Change in Quality of Life (Mental Health and Physical Health Summary Scores) | Mental health (sum) | 1.6 score on a scale |
| High Intensity Exercise HIGH-INT | Change in Quality of Life (Mental Health and Physical Health Summary Scores) | Physical health (sum) | -0.11 score on a scale |
Comparison: Change in the mental health sum scale (CON vs. HIGH-INT)p-value: 0.65ANCOVA
Comparison: Change in mental health (sum) subscale (MOD-INT vs. HIGH-INT)p-value: 0.034ANCOVA
Comparison: Change in physical health (sum)p-value: 0.33ANCOVA
Comparison: Change in physical health (sum) subscalep-value: 0.297ANCOVA
Secondary
Change in Systemic Inflammation
High sensitivity c-reactive protein will be measured at baseline and follow-up
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in Systemic Inflammation | 0.142 mg/L |
| Moderate Intensity Exercise (MOD-INT) | Change in Systemic Inflammation | 0.159 mg/L |
| High Intensity Exercise HIGH-INT | Change in Systemic Inflammation | 0.31 mg/L |
Comparison: Comparison between the CON and the HIGH-INT groupsp-value: 0.94ANCOVA
Comparison: Comparison between the CON and MOD-INT groupsp-value: 0.994ANCOVA
Comparison: Comparison between the MOD-INT and HIGH-INT groupsp-value: 0.94ANCOVA
Secondary
Change in Triglycerides
Triglyceride levels will be measured from a fasting blood sample
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in Triglycerides | -10.9 mg/dL |
| Moderate Intensity Exercise (MOD-INT) | Change in Triglycerides | 4.0 mg/dL |
| High Intensity Exercise HIGH-INT | Change in Triglycerides | -13.3 mg/dL |
Comparison: Comparison between the CON and HIGH-INT groupsp-value: 0.783ANCOVA
Comparison: Comparison between the CON and MOD-INT groupsp-value: 0.098ANCOVA
Comparison: Comparison between the MOD and HIGH-INT groupsp-value: 0.071ANCOVA
Secondary
Change in Waist Circumference
Waist circumference will be measured at the natural waist (midway between the inferior border of the rib cage and the superior aspect of the iliac crest) with a Gulick tape measure. Both landmarks (the inferior border of the ribcage and the superior aspect of the iliac crest) will be marked and the distance will be measured to determine the appropriate measurement site. Staff will confirm that: 1) the measurement tape remains horizontal; 2) the tape touches the entire circumference of the participant; 3) abdominal tissue is not compressed; 3) the tape measure is not within abdominal folds; 4) the measurement is taken at the end of normal respiration. The measurement will be repeated an additional time, and the reported value will be the average of these measurements. Both measurements must be within 0.5 cm to be considered acceptable for data purposes.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Change in Waist Circumference | -1.42 cm |
| Moderate Intensity Exercise (MOD-INT) | Change in Waist Circumference | 0.41 cm |
| High Intensity Exercise HIGH-INT | Change in Waist Circumference | -1.3 cm |
Comparison: Comparison between the CON and the HIGH-INT groupsp-value: 0.932ANCOVA
Comparison: Comparison between the CON and MOD-INT groupsp-value: 0.307ANCOVA
Comparison: Comparison between the MOD-INT and the HIGH-INT groupsp-value: 0.376ANCOVA
Secondary
Changes in Physical Activity Levels
Participants will wear an ActivPal accelerometer for seven consecutive days, 24-hrs/day. The change in steps will be be evaluated from baseline to 24 weeks
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Changes in Physical Activity Levels | 604.2 steps per day |
| Moderate Intensity Exercise (MOD-INT) | Changes in Physical Activity Levels | 2311.0 steps per day |
| High Intensity Exercise HIGH-INT | Changes in Physical Activity Levels | 2242.3 steps per day |
Comparison: Change in steps (CON vs. HIGH-INT)p-value: 0.109ANCOVA
Comparison: Change in steps (CON vs. MOD-INT)p-value: 0.099ANCOVA
Comparison: Change in steps (MOD-INT vs. HIGH-INT)p-value: 0.947ANCOVA
Secondary
Changes in Total Cholesterol
Total Cholesterol will be measured in a fasting blood sample
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control (CON) | Changes in Total Cholesterol | -10.4 mg/dL |
| Moderate Intensity Exercise (MOD-INT) | Changes in Total Cholesterol | -0.21 mg/dL |
| High Intensity Exercise HIGH-INT | Changes in Total Cholesterol | -0.71 mg/dL |
Comparison: Comparison between the CON and HIGH-INT groupsp-value: 0.224ANCOVA
Comparison: Comparison between the CON and MOD-INT groupsp-value: 0.199ANCOVA
Comparison: Comparison between the MOD-INT and the HIGH-INT groupsp-value: 0.952ANCOVA