Blood Flow Restriction Exercise for Multiple Sclerosis

(BRAVe-MS Trial)

Overseen By Eliza A Biondi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Clotting disorders, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

58 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 3 4 6 7}

How 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. ^{1 2 3 4 5}

Research Team

Mark M Manago, PT

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Eligibility 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

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.

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

Treatment Details

Interventions

• Low-Load Exercise Control Group
• Low-Load Exercise with Blood Flow Restriction

Trial Overview 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.

Participant Groups

Group I: Low-Load Exercise with Blood Flow Restriction Experimental Treatment 1 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 Control Active Control 1 Intervention

The control group with consist only of low-load resistance training under the supervision of a licensed physical therapist.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A 12-week blood flow restriction (BFR) training program combined with low-intensity resistance training (LIRT) was well tolerated by a 54-year-old woman with multiple sclerosis (MS), showing measurable improvements in strength and functional goals without increasing fatigue.

The patient experienced significant improvements in 8 out of 14 strength tests and achieved her personal functional goals, suggesting that BFR/LIRT could be a beneficial training option for individuals with MS, although further research is needed to confirm its safety and effectiveness for the broader MS population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood-Flow Restriction Training for a Person With Primary Progressive Multiple Sclerosis: A Case Report. Cohen, ET., Cleffi, N., Ingersoll, M., et al.[2021]

Low-load exercise training with blood flow restriction (BFR) has been shown to significantly increase muscle strength in clinical musculoskeletal rehabilitation, with a moderate effect size based on a systematic review of 20 studies involving various patient populations.

BFR training is more effective and tolerable than traditional low-load training, suggesting it could be a valuable rehabilitation tool, although it is less effective than heavy-load training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Hughes, L., Paton, B., Rosenblatt, B., et al.[2022]

A study involving 14 participants with advanced multiple sclerosis showed that low-load resistance training with blood flow restriction (BFR) is feasible, with a high adherence rate of 93% and no serious adverse events, except for a minor muscle strain.

Participants experienced significant improvements in muscle strength (16%-28% increase), balance, and functional mobility, suggesting that BFR training could be a beneficial alternative for those unable to tolerate higher intensity workouts due to their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Low-Load Resistance Training Using Blood Flow Restriction for People With Advanced Multiple Sclerosis: A Prospective Cohort Study. Mañago, MM., Cohen, ET., Alvarez, E., et al.[2023]

Blood flow restriction training (BFRt) was successfully applied to a 30-year-old woman with relapsing-remitting Multiple Sclerosis, leading to significant improvements in strength and balance over 8 weeks of treatment, with no adverse events reported.

This case report suggests that BFRt can be an effective intervention for enhancing physical function in individuals with MS, highlighting the need for further research to explore its broader applicability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction training for an individual with relapsing-remitting multiple sclerosis: a case report. Brown, AJ., Rachal Sant, L.[2022]

Low-load resistance exercise with blood flow restriction (LLBFR-RE) is well tolerated by individuals with multiple sclerosis (MS) and requires less effort compared to traditional high-load resistance exercise (HL-RE).

Participants reported similar levels of pain and delayed-onset muscle soreness (DOMS) after both exercise types, but LLBFR-RE did not lead to increased soreness 24 hours post-exercise, making it a safer option for those with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The perceptual responses of individuals with multiple sclerosis to blood flow restriction versus traditional resistance exercise. Freitas, EDS., Miller, RM., Heishman, AD., et al.[2021]

In a study involving 20 healthy participants, alternating (ALT) blood flow restriction (BFR) exercise resulted in significantly higher cardiovascular responses, including greater increases in aortic and mean arterial blood pressures compared to unilateral (UNI) and bilateral (BIL) patterns.

For individuals concerned about cardiovascular strain, unilateral or bilateral BFR exercises may be safer options than alternating patterns, as they produced lower cardiovascular responses during the exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute cardiovascular response to unilateral, bilateral, and alternating resistance exercise with blood flow restriction. Stanford, DM., Park, J., Jones, R., et al.[2021]

In a study involving ten young, healthy men, postexercise hypotension (PEH) was observed only after high-intensity (HI) resistance exercise, indicating that this type of exercise is more effective for lowering blood pressure compared to low-intensity blood-flow-restricted (BFR) exercise.

The research suggests that while BFR exercise is a low-intensity alternative, it may not provide the same blood pressure-lowering benefits as traditional high-intensity workouts, which could be important for populations looking to manage blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of acute blood-flow-restricted resistance exercise on postexercise blood pressure. Rossow, LM., Fahs, CA., Sherk, VD., et al.[2011]

References

1. United States pubmed.ncbi.nlm.nih.gov

Blood-Flow Restriction Training for a Person With Primary Progressive Multiple Sclerosis: A Case Report. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Low-Load Resistance Training Using Blood Flow Restriction for People With Advanced Multiple Sclerosis: A Prospective Cohort Study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Blood flow restriction training for an individual with relapsing-remitting multiple sclerosis: a case report. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The perceptual responses of individuals with multiple sclerosis to blood flow restriction versus traditional resistance exercise. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Acute cardiovascular response to unilateral, bilateral, and alternating resistance exercise with blood flow restriction. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The effect of acute blood-flow-restricted resistance exercise on postexercise blood pressure. [2011]