HIIT in Spinal Cord Injury (HIIT-SCI)
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|ClinicalTrials.gov Identifier: NCT03152110|
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : March 4, 2019
Objectives: Spinal cord injury (SCI) is debilitating to an individual's health and functional capacity and can significantly reduce quality of life. Specifically, SCI contributes to a sedentary lifestyle and a subsequent elevated risk for preventable cardiometabolic and hypokinetic diseases. While physical activity is strongly promoted in persons with SCI as a means to reduce the incidence and development of secondary disabling conditions, a majority of individuals with SCI are inactive and have low levels of fitness. High intensity interval training (HIIT) is a form of exercise that is characterized by brief, intermittent bouts of intense exercise, separated by periods of lower intensity exercise for recovery. The magnitude of improvements in aerobic exercise capacity and other key cardiometabolic risk factors following HIIT are similar to moderate-intensity continuous training, but only require a fraction of the total energy expenditure and a vastly reduced time commitment. Little research has been conducted on HIIT in persons with SCI, who are unique from other special population groups due to their inability to carry out conventional lower limb HIIT exercises. An upper extremity form of HIIT that is effective, safe, quick and has acceptable positive affect could be an attractive option for persons with SCI who are not presently exercising and have low fitness levels. The study will look at feasibility and acceptability of a 6-week HIIT program for persons with a spinal cord injury who are untrained.
Methods: Investigators aim to test 10 individuals with spinal cord injury/dysfunction who are untrained and use a manual wheelchair full time for mobility. Prior to starting any testing or exercising, participants will be screened and will need to obtain a signed medical release form from their physician. The screening procedure will include asking the participant the inclusion/exclusion criteria and administering two short questionnaires related to physical activity that will determine eligibility for the study. After obtaining the release form, participants will be scheduled for their first visit. During Visit 1, participants will complete baseline exercise testing and questionnaires. The study questionnaires will include questionnaires related to sociodemographics, pain and health measures, general health and function, and physical activity. Exercise testing includes an aerobic exercise stress test (conducted following American College of Sports Medicine guidelines using an electronic ergometer) and an anaerobic (maximum power output) test. After Visit 1, participants will exercise three times per week for six weeks, following a standard HIIT protocol. Two of those sessions will be supervised by a trainer, and one session will be completed on their own. After the six week time period, participants will be scheduled for Visit 2 and will complete the same evaluations as Visit 1. Additionally, participants will complete evaluations measuring the level of satisfaction of the training program and their likelihood of continuing the program.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries Spinal Cord Diseases||Other: HIIT||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Acceptability of Six-weeks of High Intensity Interval Training in Wheelchair Users With SCI|
|Actual Study Start Date :||January 2, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery.
A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery.
Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs.
Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed during the previous supervised session. The bike computer automatically stores HR and PPO.
- HIIT Times [ Time Frame: To be recorded weekly, throughout study completion (3x/week for 6 weeks) ]Work/rest times (minutes)
- Power [ Time Frame: To be completed at baseline, at 6 weeks post-study completion; throughout each training session (3x/week for 6 weeks) ]Peak/average power (watts)
- Cardiopulmonary Measures [ Time Frame: To be completed at baseline and at 6 weeks post-study completion ]VO2, CO2, VE, VE/CO2 and VE/VCO2 (all measured in L/min)
- Cardiopulmonary Measures [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion; throughout each training session (3x/week for 6 weeks) ]Heart rate (bpm)
- Enjoyment of HIIT [ Time Frame: To be completed at 6 weeks post-study completion ]Physical Activity Enjoyment Scale (PACES)
- Acceptability of HIIT [ Time Frame: To be completed at 6 weeks post-study completion ]Exercise Evaluation Form
- Feasibility of HIIT [ Time Frame: To be recorded throughout study completion (6 weeks) ]Total days of exercise completed
- Physical Activity Status [ Time Frame: To be completed at baseline ]The physical activity scale for individuals with physical disabilities (PASIPD)
- Perceived Exertion [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion; throughout each training session (3x/week for 6 weeks) ]Borg Scale (6-20)
- Perceived Exertion (Adapted) [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion; throughout each training session (3x/week for 6 weeks) ]Wheel Scale (1-10)
- Feelings During HIIT [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion; throughout each training session (3x/week for 6 weeks) ]Feeling Scale (-6 to +6)
- Wrist, Elbow, Shoulder Pain [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion ]Numerical Rating Scale
- Shoulder Pain [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion ]Wheelchair Users Shoulder Pain Index
- General Health & Function [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion ]SF-36 WW
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152110
|Contact: Stacy Ecksteinemail@example.com|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15206|
|Contact: Stacy Eckstein 412-822-3700 firstname.lastname@example.org|
|Principal Investigator: Alicia Koontz, PhD|