Blood Flow Restriction Exercise for Multiple Sclerosis
(BRAVe-MS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Cognitive impairment, Clotting disorders, Hypertension, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have had changes to your MS-related drug therapy in the month before joining, you may not be eligible.
What data supports the effectiveness of the treatment Blood Flow Restriction Exercise for Multiple Sclerosis?
Research suggests that blood flow restriction training, combined with low-intensity resistance training, can help people with multiple sclerosis improve strength without increasing fatigue. This approach has shown similar benefits to traditional exercise in healthy individuals and may be feasible for those with advanced MS.
12345Is blood flow restriction exercise generally safe for humans?
Blood flow restriction exercise, which involves using a cuff to partially restrict blood flow during low-intensity exercise, has been used safely in healthy populations and may help improve strength without increasing fatigue in people with multiple sclerosis. However, its effects on blood pressure and cardiovascular response need further study, especially in different populations.
13467How is blood flow restriction exercise different from other treatments for multiple sclerosis?
Blood flow restriction exercise is unique because it combines low-intensity resistance training with a special cuff that partially restricts blood flow, allowing people with multiple sclerosis to improve strength without increasing fatigue, unlike traditional high-intensity exercises.
12345Eligibility Criteria
This trial is for Veterans aged 18-75 with a confirmed MS diagnosis who need assistance to walk or use a wheelchair but can sit in one for over an hour. They should not have severe cognitive issues, recent blood clots, extremely high blood pressure, intense leg muscle stiffness, or be on certain MS treatments.Inclusion Criteria
I need a cane to walk because of my condition.
I need help to walk.
Patient Determined Disease Steps (PDDS) 4 to 7
+4 more
Exclusion Criteria
My MS allows me to do daily activities without help.
I have other health conditions or pain that affect my physical abilities.
I cannot do a seated leg press or fully straighten my knee against gravity in at least one leg.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo low-load resistance training with or without blood flow restriction for 10 weeks
10 weeks
2 visits per week (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
8 weeks
1 visit (in-person) at the end of follow-up
Participant Groups
The study tests a strength training program using Blood Flow Restriction (BFR) designed for those with advanced disability from MS. BFR partially blocks blood flow during exercise, simulating high-intensity workouts at lower intensities which may improve strength and quality of life.
2Treatment groups
Experimental Treatment
Active Control
Group I: Low-Load Exercise with Blood Flow RestrictionExperimental Treatment1 Intervention
The BFR intervention will combine low-load resistance training with between 60%-80% blood flow occlusion under the supervision of a licensed physical therapist.
Group II: Low-Load Exercise ControlActive Control1 Intervention
The control group with consist only of low-load resistance training under the supervision of a licensed physical therapist.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rocky Mountain Regional VA Medical Center, Aurora, COAurora, CO
Loading ...
Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Blood-Flow Restriction Training for a Person With Primary Progressive Multiple Sclerosis: A Case Report. [2021]Blood flow restriction (BFR) training, in which an inflatable cuff partially occludes blood flow around the proximal portion of a limb, coupled with low-intensity resistance training (LIRT) has resulted in gains comparable with traditional progressive resistive exercise in healthy populations. The use of BFR with LIRT may enable people with multiple sclerosis (MS) to improve strength without an increase in fatigue. The purpose of this case report is to describe the use of a BFR/LIRT program for a person with MS.
Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. [2022]Low-load exercise training with blood flow restriction (BFR) can increase muscle strength and may offer an effective clinical musculoskeletal (MSK) rehabilitation tool. The aim of this review was to systematically analyse the evidence regarding the effectiveness of this novel training modality in clinical MSK rehabilitation.
Feasibility of Low-Load Resistance Training Using Blood Flow Restriction for People With Advanced Multiple Sclerosis: A Prospective Cohort Study. [2023]The objective of this study was to determine the feasibility of low-load resistance training with blood flow restriction (BFR) for people with advanced disability due to multiple sclerosis (MS).
Blood flow restriction training for an individual with relapsing-remitting multiple sclerosis: a case report. [2022]Individuals with Multiple Sclerosis (MS) often present with weakness, poor balance, and increased fatigue that affects physical function. Blood flow restriction training (BFRt) is a popular treatment method to improve strength in orthopedic patients. However, research is limited on the use of BFRt for individuals with MS. This case report describes the effects of BFRt for an individual with relapsing-remitting MS (RRMS).
The perceptual responses of individuals with multiple sclerosis to blood flow restriction versus traditional resistance exercise. [2021]Label="BACKGROUND">Low-load resistance exercise with blood flow restriction (LLBFR-RE) has been shown capable of improving neuromuscular parameters in several clinical populations, however, its tolerability and effects on individuals with multiple sclerosis (MS) remains unknown.
Acute cardiovascular response to unilateral, bilateral, and alternating resistance exercise with blood flow restriction. [2021]Blood flow restriction (BFR) exercise is a common alternative to traditional high-load resistance exercise used to increase muscle size and strength. Some populations utilizing BFR at a low load may wish to limit their cardiovascular response to exercise. Different contraction patterns may attenuate the cardiovascular response, but this has not been compared using BFR.
The effect of acute blood-flow-restricted resistance exercise on postexercise blood pressure. [2011]Blood-flow-restricted (BFR) exercise is an emerging type of exercise that may be particularly beneficial to elderly or special populations. These populations may also benefit from reductions in blood pressure (BP). The effect of BFR exercise on postexercise BP has not been examined; this should first be examined in a young, healthy population as a preliminary investigation.