Examining a Wheelchair Exercise-training Intervention for Persons With Multiple Sclerosis (NCT05888727) | Clinical Trial Compass
CompletedNot Applicable
Examining a Wheelchair Exercise-training Intervention for Persons With Multiple Sclerosis
United States24 participantsStarted 2024-01-17
Plain-language summary
The goal of this randomized controlled clinical trial is to examine the feasibility and initial efficacy of undertaking and delivering a novel, stakeholder-informed exercise training program for wheelchair users with multiple sclerosis. The main questions it aims to answer are:
* Is the study feasible as measured by participant recruitment (24 participants total), retention (80%), and safety (adverse events)?
* Is the study acceptable as measured by participant satisfaction and perceptions using an evaluation survey and semi-structured interviews?
* Is there significant change in following the 16-week study in metabolic health outcomes, MS symptoms, and exercise behavior change? Participants will be randomized to complete the 16-week SPIN exercise training program or WellMS attention/contact wellness program.
Researchers will compare the SPIN and WellMS groups to determine if there is a significant difference in metabolic health outcomes, MS symptoms, and exercise behavior change.
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:
* diagnosis of MS
* self-reported use of a wheelchair (i.e., manual wheelchair, power wheelchair, or scooter) \>50% of the time
* age of 18 years or older
* relapse free for the past 30 days
* being non-active defined as not engaging in regular physical activity (30 minutes accumulated per day) on more than 2 days of the week during the previous 6 months (i.e., not meeting current physical activity guidelines for MS)
Exclusion Criteria:
* during telephone screening participants will complete an exercise pre-participation health screen and if participants report any symptoms or conditions contradictive of exercise then physician clearance will be required before enrollment
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
Study Feasibility: Number of Participants Recruited
Timeframe: 16-weeks
2
Study Feasibility: Number of Participants Retained
Timeframe: 16-weeks
3
Study Feasibility: Number of Participants With Study-Related Adverse Events
Timeframe: 16-weeks
Trial details
NCT IDNCT05888727
SponsorThe University of Texas Health Science Center, Houston