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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new exercise method called blood flow restriction (BFR) training for people with multiple sclerosis (MS) who have trouble walking or use a wheelchair. BFR training uses a device that partially blocks blood flow to boost muscle strength with less intense workouts. The goal is to improve strength, mobility, fatigue, and quality of life in those with significant MS-related disabilities. Participants should have MS and need assistance walking or use a wheelchair. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily living for those 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 prior data suggests that blood flow restriction exercise is safe for people with advanced disability due to MS?

Research shows that low-load exercise with blood flow restriction (BFR) is generally safe for people with multiple sclerosis (MS). Studies have found that this type of exercise can boost muscle strength and reduce tiredness without causing major side effects. People with MS who have tried BFR report feeling more active and better overall.

In past studies, most participants handled BFR well, experiencing no serious issues. This is crucial for people with MS, especially those with more severe symptoms, as they may find intense workouts difficult. BFR allows them to benefit from easier, lower-intensity exercise.

Overall, BFR training seems to be a promising way to improve life quality for people with advanced MS. However, consulting a healthcare provider before starting any new exercise routine is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of low-load exercise with blood flow restriction (BFR) for multiple sclerosis (MS) because it offers a new approach to improving muscle strength and function without the need for heavy weights. Unlike traditional MS treatments, which often focus on medications like disease-modifying therapies to slow disease progression, this method uses a novel technique of combining light resistance exercises with controlled blood flow restriction. This could make exercise more accessible for individuals with MS who may struggle with high-intensity workouts, potentially leading to better adherence and outcomes. The supervised BFR approach may enhance the benefits of exercise by maximizing muscle activation and strength gains, offering a promising complementary strategy to existing MS management options.

What evidence suggests that blood flow restriction exercise is effective for multiple sclerosis?

Research has shown that using blood flow restriction (BFR) during light exercise can benefit people with multiple sclerosis (MS). In this trial, one group will perform low-load exercise with BFR, which studies have found strengthens leg muscles in people with MS. This training is promising because it builds strength without requiring intense workouts, which can be challenging for those with severe MS-related disabilities. Additionally, BFR training has reduced fatigue and increased overall physical activity. These benefits suggest that BFR could effectively strengthen muscles and improve the quality of life for people with advanced MS. ^{1 3 4 6 7}

Who Is on the Research Team?

Mark M Manago, PT

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37815934/

Feasibility of Low-Load Resistance Training Using Blood Flow ... Conclusion: Low-load resistance training using BFR in people with MS and EDSS scores of 6.0 to 7.0 appears feasible, and subsequent ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034825005164

Effect of Blood Flow Restriction with Low-Intensity Exercise ... The current study showed that BFR combined with low-intensity resisted exercise improves lower limb muscular strength in PwMS. Statistically ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39585063/

Effectiveness and Feasibility of Blood Flow Restriction ... Conclusions: BFRT in people with MS appears to be effective and safe for people with MS. BFRT might show positive clinical effects on strength, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04633759

Low Load Resistance Training Using Blood Flow ... The Primary Aim of this research study is to determine the feasibility of 8 weeks of physical therapy strengthening exercises using blood flow restriction (BFR) ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1440244025004724

Blood flow restriction training improves strength, fatigue ... The results showed significant improvements in perceived disease impact, muscle strength, fatigue, physical activity levels, and manual ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10822774/

Feasibility of Low-Load Resistance Training Using Blood ... This study demonstrated the feasibility of low-load resistance training using BFR in people who have advanced disability due to MS. In addition, there were ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05177952

Low-Load Blood Flow Restriction on Patients With Multiple ... The purpose of this study is to compare the effectiveness of the current Multiple Sclerosis standard of care exercise recommendations to low-load resistance ...