Exercise Training and Manual Wheelchair Users With SCI (NCT03727893) | Clinical Trial Compass
CompletedNot Applicable
Exercise Training and Manual Wheelchair Users With SCI
United States14 participantsStarted 2018-10-22
Plain-language summary
The overall purpose of this pilot randomized control trial (RCT) is to determine the efficacy of the high-intensity interval training (HIIT) exercise protocols for the WheelMill System (WMS) to improve exercise intensity, cardiovascular fitness, metabolic health, and psychological well-being in manual wheelchair users (MWUs) with spinal cord injury (SCI).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants will have a diagnosis of spinal cord injury (SCI)
* be18 years or older
* have the ability to self-propel a manual wheelchair (MWC) bilaterally with their upper extremities
* use a MWC for at least 75% of their daily activities
* participate in less than 60 minutes of moderate-intensity exercise per week in the last month
* have written physician approval to participate in the study
* understand English at a sixth-grade level or higher
* be able to follow multi-step instructions
* independently provide informed consent
* be willing to participate in two assessments and 36 intervention sessions at the Enabling Mobility in the Community Laboratory (EMC Lab).
Exclusion Criteria:
* maneuver MWC with their lower extremities or with only one upper extremity
* have bilateral incoordination due to strength inequality or neurological involvement that impairs propulsion in a steady, straight line
* have had surgeries compromising the integrity of the upper extremities or cardiovascular complications within the past year
* currently receive medical treatment for an acute upper extremity injury
* have a Stage IV pressure injury
* are currently hospitalized
* have a cognitive impairment that does not allow them to provide consent or follow multi-step directions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
VO2peak Change
Timeframe: Baseline to Post Intervention at 4 months
2
The 6-minute Push Test (6MPT) Change
Timeframe: Baseline to Post Intervention at 4 months