High Intensity Interval Exercise SCI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Telehealth High Intensity Interval Exercise and Cardiometabolic Health in Spinal Cord Injury

Conditions
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Spinal Cord Injuries, Cardiometabolic Diseases

Intervention / Treatment
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* Other: high intensity interval exercise
* Other: No-exercise control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, 19-65 years of age. 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. At least 6 months post-injury. Able to independently operate an arm ergometer. Have access to a wireless internet connection. Medically stable, able to provide informed consent. Exclusion Criteria: Cardiovascular or renal diseases. Pregnant women Orthopedic conditions that prevents arm ergomtery Upper extremity musculoskeletal conditions that prevents arm ergometry. Neurological disorder that prevents arm ergometry Participation in a structured exercise program currently or in the past 3 months. Unable to perform exercise interventions -

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity interval exercise<br>High intensity interval arm crank exercise | Other: high intensity interval exercise<br>* 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.<br>|
| Other: No-Exercise Control<br>No-exercise control group | Other: No-exercise control group<br>* No-exercise control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Aerobic Capacity | 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. | baseline | 
| Change in Aerobic Capacity | 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. | 16weeks post training | 
| Change in Muscular Strength | Muscle Strength Assessment. Maximal load that can be lifted in one repetition (1RM) will be assessed in both limbs for chest press, elbow flexion, and shoulder flexion maneuvers. | baseline | 
| Change in Muscular Strength | Muscle Strength Assessment. Maximal load that can be lifted in one repetition (1RM) will be assessed in both limbs for chest press, elbow flexion, and shoulder flexion maneuvers. | 16weeks post | 
| Change in Insulin Sensitivity | 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. | baseline | 
| Change in Insulin Sensitivity | 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. | 16weeks post training | 
| Change in Blood Lipids | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | baseline | 
| Change in Blood Lipids | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | 16weeks post training | 
| Change in Body Composition | Dual-energy X-ray absorptiometry (DXA). Total and regional body composition will be measured by DXA (Lunar Radiation Corp., Madison, WI) at the Lakeshore Foundation Research Facility. | baseline | 
| Change in Body Composition | Dual-energy X-ray absorptiometry (DXA). Total and regional body composition will be measured by DXA (Lunar Radiation Corp., Madison, WI) at the Lakeshore Foundation Research Facility. | 16weeks post training | 
| Change in Blood Pressure | Systolic and Diastolic blood pressure will be assessed using standard blood pressure cuff and a stethoscope. | baseline | 
| Change in Blood Pressure | Systolic and Diastolic blood pressure will be assessed using standard blood pressure cuff and a stethoscope. | 16weeks post training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semi-Structured Interview | The semi-structured interviews will contain seven open-ended questions related to the following areas: 1) overall perceptions of the program, 2) program likes, 3) dislikes, 4) perceived satisfaction and 5) value, 6) technology and equipment usability, and 7) factors that affected adherence. These areas will be probed in greater detail by the interviewer through additional follow-up questions. | 16 weeks post-training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Intensity Interval Training, Telehealth Exercise, Armcrank Exercise, SCI