Blood Flow Restriction And Veterans With MS
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT05433103
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Low-Load Exercise with Blood Flow Restriction — OTHERParticipants in the BFR group will attend a 10-week, twice weekly intervention exercise session combining low-load resistance training with at least 60% blood flow occlusion. Standard education regarding the importance of exercise for people with MS will also be provided. All participants will also be asked to practice a home exercise program focusing on functional tasks one time a week.
- Low-Load Exercise Control Group — OTHERParticipants in the Control group will attend a 10-week, twice weekly intervention exercise session combining low-load resistance training. Standard education regarding the importance of exercise for people with MS will also be provided. All participants will also be asked to practice a home exercise program focusing on functional tasks one time a week.
Study Details
There currently is a lack of evidence to support exercise interventions in people with advanced disability due to MS (i.e., need assistance to walk or use a wheelchair). This project proposes to study a strength training program using blood flow restriction (BFR) in people with advanced disability due to MS. BFR uses a device that partially blocks blood flow to the exercising limb and causes a response in the muscle which can replicate the effects of high-intensity training using much lower intensities. This is ideal for people with MS who have advanced disability, as they often cannot tolerate higher intensity exercise due to severe weakness and fatigue. By studying BFR training in people with advanced disability due to MS, the investigators hope to help improve strength, mobility, fatigue, and quality of life in people with MS. This study will target enrollment of Veterans with MS, who tend to have more advanced disability than non-Veterans with MS.
Key Dates
- Start date
- Jan 1, 2023
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 58 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Low-Load Exercise with Blood Flow RestrictionThe BFR intervention will combine low-load resistance training with between 60%-80% blood flow occlusion under the supervision of a licensed physical therapist.
- Active Comparator: Low-Load Exercise ControlThe control group with consist only of low-load resistance training under the supervision of a licensed physical therapist.
Primary Outcome Measure
Quadriceps muscle strength [ Time Frame: Change in muscle strength between Baseline (Week 0) and Primary Endpoint (Week 11) ]
Central Contacts
- Mark M Manago, PT(303) 399-8020
- Eliza A Biondi(303) 724-9170
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045-7211 | Mark M Manago, PT (PRINCIPAL_INVESTIGATOR) |
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