Spinal Cord Injuries, Cardiometabolic Diseases
Conditions
Keywords
High Intensity Interval Training, Telehealth Exercise, Armcrank Exercise, SCI
Brief summary
This study will determine if the implementation of a home-based telehealth high intensity interval exercise-training (HIIT)program can significantly improve cardiometabolic health and physical function in a cohort of individuals with longstanding spinal cord injury (SCI). Results from this study will determine feasibility, overall enjoyment, and health impact of implementing a home-based telehealth HIIT program in individuals with SCI.
Detailed description
For individuals with spinal cord injury (SCI), exercise participation reduces the risk of developing chronic cardiometabolic diseases, which are leading causes of rehospitalization and death within this population. Accordingly, recent SCI exercise guidelines have highlighted a need for exercise trials that can improve cardiometabolic factors such as glucose tolerance, blood lipids, blood pressure, and body composition. However, to date, the number of exercise trials examining these cardiometabolic outcomes in SCI is low, and these exercise regimens are often inconvenient for individuals with SCI to perform within their community. In addition to the functional impairment associated with the disability, individuals with SCI experience a number of barriers to exercise participation, such as lack of time (e.g. conflict with work schedule), accessible or usable equipment and facilities, and transportation. Thus, it is important to identify effective modes of exercise that can improve overall health but do not require a significant overall weekly time commitment. Investigators recently demonstrated that individuals with SCI could safely perform high intensity interval training (HIIT) using arm crank cycling and that as few as two days per week of HIIT could improve cardiometabolic health. Despite the advantages of HIIT, it is important to identify methods of implementing exercise trials that can successfully reach and maintain participation in larger cohorts. Recent work by the investigative group demonstrated that individuals with SCI expressed favorable perceptions of home-exercise training that incorporated telehealth technology, which allowed a fitness specialist to remotely monitor participants' training progress in real-time and provide verbal support via videoconferencing. This method of training holds even greater value for home-exercise programs that require monitoring to dose-specific protocols such as HIIT. However, the long-term success of HIIT will greatly depend on the ease at which the program can be implemented, as well as participants' adherence and perceptions of using the technology, which has not been investigated in SCI. The goal of this study is to integrate a home-based telehealth HIIT arm crank exercise training program in individuals with SCI and assess changes in cardiometabolic health and physical function. The secondary goal is to explore the uptake and implementation of HIIT in SCI. 40 participants will be randomized to home-based HIIT exercise or a no-exercise control group for 16-weeks. Body composition, aerobic fitness, muscular strength, and changes in cardiometabolic health will be assessed at baseline and 16-weeks post training. In addition to changes in cardiometabolic health outcomes, the investigators will also conduct interviews with participants to determine overall perceptions of the program, program likes and dislikes, perceived satisfaction and value, usability of equipment and technology, and factors that influence adherence.
Interventions
HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
OTHERNo-exercise control group
No-exercise control group
Sponsors
National Institute of Nursing Research (NINR)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
In a longitudinal study design, 40 participants with chronic SCI will be randomly assigned to one of the two study groups (HIIT and control) in a 1:1 ratio. Randomization will be performed using the block randomization method, Randomization will be performed using the block randomization method. A randomization list will be generated and assignments will be placed into closed envelopes and given to each study participant. Participants will be assessed at baseline and 16-wks post HIIT or control
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women, 19-65 years of age. 2. Confirmed diagnosis of traumatic SCI at the cervical or thoracic level (C7-T12), classified as A, B, C, or D (motor and sensory complete or incomplete) on the AIS scale. 3. At least 6 months post-injury. 4. Able to independently operate an arm ergometer. 5. Have access to a wireless internet connection. 6. Medically stable, able to provide informed consent.
Exclusion criteria
1. Cardiovascular or renal diseases. 2. Pregnant women 3. Orthopedic conditions that prevents arm ergomtery 4. Upper extremity musculoskeletal conditions that prevents arm ergometry. 5. Neurological disorder that prevents arm ergometry 6. Participation in a structured exercise program currently or in the past 3 months. 7. Unable to perform exercise interventions \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic Capacity Baseline | baseline | All subjects will undergo a progressive peak oxygen assessment to determine aerobic capacity at the Lakeshore Foundation Exercise Physiology Facility. Subjects will be instructed to perform arm crank ergometer (Lode) at 10W for 2 min. Every 2 min thereafter, power output will be increased by 10W until voluntary fatigue. Peak aerobic power will be defined as VO2 at the point of failure to maintain 60-65 rotations per minute. |
| Aerobic Capacity Week 16 | 16weeks post training | All subjects will undergo a progressive peak oxygen assessment to determine aerobic capacity at the Lakeshore Foundation Exercise Physiology Facility. Subjects will be instructed to perform arm crank ergometer (Lode) at 10W for 2 min. Every 2 min thereafter, power output will be increased by 10W until voluntary fatigue. Peak aerobic power will be defined as VO2 at the point of failure to maintain 60-65 rotations per minute. |
| Matsuda Index Baseline | baseline | Oral glucose tolerance test. Following an overnight fast each subject will consume a 75g oral glucose load within 5 min. Blood samples will be collected immediately before and 60, 90, and 120 min following glucose ingestion for measurement of serum glucose and serum insulin. Insulin sensitivity was calculated using glucose and insulin values by the Matsuda Index, in which a higher number demonstrates an improvement in insulin sensitivity, |
| Matsuda Index Week 16 | 16weeks post training | Oral glucose tolerance test. Following an overnight fast each subject will consume a 75g oral glucose load within 5 min. Blood samples will be collected immediately before and 60, 90, and 120 min following glucose ingestion for measurement of serum glucose and serum insulin. Insulin sensitivity was calculated using glucose and insulin values by the Matsuda Index, in which a higher number demonstrates an improvement in insulin sensitivity, |
| Cholesterol Baseline | baseline | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. |
| Cholesterol Week 16 | 16weeks post training | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. |
| Body Composition Baseline | baseline | Dual-energy X-ray absorptiometry (DXA). Percent Body Fat |
| Body Composition Week 16 | 16weeks post training | Dual-energy X-ray absorptiometry (DXA). Percent Body Fat |
| Triglycerides Baseline | baseline | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. |
| Triglycerides Week 16 | 16-weeks post | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. |
| HDL Baseline | Baseline | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. |
| HDL Week 16 | 16-weeks post training | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. |
| LDL Baseline | Baseline | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. |
| LDL Week 16 | 16-weeks post training | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. |
Countries
United States
Participant flow
Recruitment details
Potential participants were identified by a computer-generated list of patients who are enrolled in the UAB SCI Model System and the Lakeshore Foundation Member Database and currently reside in the greater Birmingham, Alabama area. All potential participants were mailed a letter which describes the study, invites them to participate. Additional recruiting was done by posting fliers at the UAB Spain Rehabilitation Center (SRC) and Lakeshore Foundation.
Participants by arm
| Arm | Count |
|---|---|
| High Intensity Interval Exercise High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power. | 5 |
| No-Exercise Control No-exercise control group
No-exercise control group: No-exercise control group | 3 |
| Total | 8 |
Baseline characteristics
| Characteristic | No-Exercise Control | High Intensity Interval Exercise | Total |
|---|---|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 8.1 | 50.6 years STANDARD_DEVIATION 11.6 | 52.7 years STANDARD_DEVIATION 10.2 |
| Body Weight | 94.3 kg STANDARD_DEVIATION 30.9 | 87.2 kg STANDARD_DEVIATION 23.7 | 89.9 kg STANDARD_DEVIATION 24.7 |
| Fasting Glucose | 148.3 mg/dl STANDARD_DEVIATION 85.6 | 95.2 mg/dl STANDARD_DEVIATION 3.5 | 115.1 mg/dl STANDARD_DEVIATION 53.4 |
| Fasting Insulin | 7.6 mIU/L STANDARD_DEVIATION 4.1 | 10.6 mIU/L STANDARD_DEVIATION 4.3 | 9.5 mIU/L STANDARD_DEVIATION 4.2 |
| HDL | 51.7 mg/dl STANDARD_DEVIATION 0.58 | 45.6 mg/dl STANDARD_DEVIATION 6.9 | 47.9 mg/dl STANDARD_DEVIATION 6.1 |
| Height | 66.7 inches STANDARD_DEVIATION 6.4 | 69.7 inches STANDARD_DEVIATION 2.9 | 68.6 inches STANDARD_DEVIATION 4.4 |
| Insulin Sensitivity | 6.1 matsuda STANDARD_DEVIATION 4.2 | 3.5 matsuda STANDARD_DEVIATION 1.8 | 4.5 matsuda STANDARD_DEVIATION 2.9 |
| LDL | 101.1 mg/dl STANDARD_DEVIATION 9 | 107 mg/dl STANDARD_DEVIATION 30.4 | 104.8 mg/dl STANDARD_DEVIATION 23.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 5 Participants |
| Total Cholesterol | 178 mg/dl STANDARD_DEVIATION 4.3 | 179.2 mg/dl STANDARD_DEVIATION 36 | 178.8 mg/dl STANDARD_DEVIATION 27.4 |
| Triglycerides | 126.3 mg/dl STANDARD_DEVIATION 30 | 132.6 mg/dl STANDARD_DEVIATION 46.3 | 130.2 mg/dl STANDARD_DEVIATION 38.7 |
| VO2 Peak | 10.1 ml/kg/min STANDARD_DEVIATION 0.99 | 11.6 ml/kg/min STANDARD_DEVIATION 2.9 | 11 ml/kg/min STANDARD_DEVIATION 2.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 0 / 5 | 0 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 3 |
Outcome results
Primary
Aerobic Capacity Baseline
All subjects will undergo a progressive peak oxygen assessment to determine aerobic capacity at the Lakeshore Foundation Exercise Physiology Facility. Subjects will be instructed to perform arm crank ergometer (Lode) at 10W for 2 min. Every 2 min thereafter, power output will be increased by 10W until voluntary fatigue. Peak aerobic power will be defined as VO2 at the point of failure to maintain 60-65 rotations per minute.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | Aerobic Capacity Baseline | 11.6 ml/kg/min | Standard Deviation 2.9 |
| No-Exercise Control | Aerobic Capacity Baseline | 10 ml/kg/min | Standard Deviation 0.99 |
Primary
Aerobic Capacity Week 16
All subjects will undergo a progressive peak oxygen assessment to determine aerobic capacity at the Lakeshore Foundation Exercise Physiology Facility. Subjects will be instructed to perform arm crank ergometer (Lode) at 10W for 2 min. Every 2 min thereafter, power output will be increased by 10W until voluntary fatigue. Peak aerobic power will be defined as VO2 at the point of failure to maintain 60-65 rotations per minute.
Time frame: 16weeks post training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | Aerobic Capacity Week 16 | 13.6 ml/kg/min | Standard Deviation 2.2 |
| No-Exercise Control | Aerobic Capacity Week 16 | 9.9 ml/kg/min | Standard Deviation 2.5 |
Primary
Body Composition Baseline
Dual-energy X-ray absorptiometry (DXA). Percent Body Fat
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | Body Composition Baseline | 42.4 Percent Fat | Standard Deviation 1.1 |
| No-Exercise Control | Body Composition Baseline | 47.5 Percent Fat | Standard Deviation 6.8 |
Primary
Body Composition Week 16
Dual-energy X-ray absorptiometry (DXA). Percent Body Fat
Time frame: 16weeks post training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | Body Composition Week 16 | 41.9 Percent Fat | Standard Deviation 2.8 |
| No-Exercise Control | Body Composition Week 16 | 46.9 Percent Fat | Standard Deviation 7.2 |
Primary
Cholesterol Baseline
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | Cholesterol Baseline | 179.2 mg/dl | Standard Deviation 36 |
| No-Exercise Control | Cholesterol Baseline | 178 mg/dl | Standard Deviation 4.4 |
Primary
Cholesterol Week 16
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Time frame: 16weeks post training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | Cholesterol Week 16 | 193.8 mg/dl | Standard Deviation 49.5 |
| No-Exercise Control | Cholesterol Week 16 | 188 mg/dl | Standard Deviation 25.3 |
Primary
HDL Baseline
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | HDL Baseline | 45.6 mg/dl | Standard Deviation 6.9 |
| No-Exercise Control | HDL Baseline | 51.7 mg/dl | Standard Deviation 0.6 |
Primary
HDL Week 16
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Time frame: 16-weeks post training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | HDL Week 16 | 52 mg/dl | Standard Deviation 9.6 |
| No-Exercise Control | HDL Week 16 | 57.7 mg/dl | Standard Deviation 8 |
Primary
LDL Baseline
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | LDL Baseline | 107.1 mg/dl | Standard Deviation 30.4 |
| No-Exercise Control | LDL Baseline | 101.1 mg/dl | Standard Deviation 8 |
Primary
LDL Week 16
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Time frame: 16-weeks post training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | LDL Week 16 | 117.5 mg/dl | Standard Deviation 48.1 |
| No-Exercise Control | LDL Week 16 | 109.7 mg/dl | Standard Deviation 22 |
Primary
Matsuda Index Baseline
Oral glucose tolerance test. Following an overnight fast each subject will consume a 75g oral glucose load within 5 min. Blood samples will be collected immediately before and 60, 90, and 120 min following glucose ingestion for measurement of serum glucose and serum insulin. Insulin sensitivity was calculated using glucose and insulin values by the Matsuda Index, in which a higher number demonstrates an improvement in insulin sensitivity,
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | Matsuda Index Baseline | 3.5 score on a scale | Standard Deviation 1.8 |
| No-Exercise Control | Matsuda Index Baseline | 6.1 score on a scale | Standard Deviation 4.2 |
Primary
Matsuda Index Week 16
Oral glucose tolerance test. Following an overnight fast each subject will consume a 75g oral glucose load within 5 min. Blood samples will be collected immediately before and 60, 90, and 120 min following glucose ingestion for measurement of serum glucose and serum insulin. Insulin sensitivity was calculated using glucose and insulin values by the Matsuda Index, in which a higher number demonstrates an improvement in insulin sensitivity,
Time frame: 16weeks post training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | Matsuda Index Week 16 | 5.3 score on a scale | Standard Deviation 3.5 |
| No-Exercise Control | Matsuda Index Week 16 | 6.5 score on a scale | Standard Deviation 5.9 |
Primary
Triglycerides Baseline
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | Triglycerides Baseline | 132.6 mg/dl | Standard Deviation 46.3 |
| No-Exercise Control | Triglycerides Baseline | 126.3 mg/dl | Standard Deviation 30.1 |
Primary
Triglycerides Week 16
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Time frame: 16-weeks post
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Exercise | Triglycerides Week 16 | 122.8 mg/dl | Standard Deviation 39.1 |
| No-Exercise Control | Triglycerides Week 16 | 102.3 mg/dl | Standard Deviation 44.3 |