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 — OTHER
    Participants 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 — OTHER
    Participants 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 Restriction
    The 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 Control
    The 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

Locations (1)

FacilityCityStateZIPSite coordinators
Rocky Mountain Regional VA Medical Center, Aurora, COAuroraColorado80045-7211
Mark M Manago, PT
303-399-8020
Eliza A Biondi
(303) 724-9170
Mark M Manago, PT (PRINCIPAL_INVESTIGATOR)

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