Exercise for Stroke Recovery

(EBH Trial)

Overseen By Charlene Hafer-Macko, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baltimore VA Medical Center

Disqualifiers: Unstable angina, Myocardial infarction, Congestive heart failure, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 76

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a 6-month, low-intensity group exercise class can improve fitness, walking, balance, and brain health in individuals who have had a stroke or possess risk factors such as high blood pressure or diabetes. Participants will attend group classes three times a week, focusing on activities like walking, balance exercises, and an obstacle course. It suits those who can walk 30 feet without assistance and have completed their regular post-stroke physical therapy. The trial aims to determine if regular exercise can lower the risk of future strokes and aid overall recovery. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance recovery and reduce stroke risk for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this exercise program is safe for stroke recovery?

Research shows that exercise is a safe and effective way to aid stroke recovery. Studies have found that structured exercise programs are safe for stroke patients. For example, one study confirmed that exercise is both safe and beneficial for stroke recovery. Another study found no safety issues with aerobic exercise, which strengthens the heart and lungs, for patients recovering from a stroke.

These findings suggest that regular exercise is generally well-tolerated by people recovering from a stroke. Exercise can also enhance fitness, balance, and overall brain health, which are important for recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how structured exercise can aid in stroke recovery, offering a potentially accessible and low-cost option for patients. Unlike traditional treatments like medication or surgery, this approach focuses on physical rehabilitation through a group exercise class that includes walking, balance exercises, and even an obstacle course. By emphasizing movement and balance, this program might improve recovery outcomes and enhance quality of life in a way that's different from standard care. Plus, the social component of group classes could offer additional motivational benefits.

What evidence suggests that exercise is effective for stroke recovery?

Research shows that physical activity can significantly aid recovery after a stroke. In this trial, participants in the Group Exercise Class arm will follow a structured exercise program, including walking, bodyweight and balance exercises, and an obstacle course. Studies have found that exercise enhances brain function after a stroke. It also improves mobility and makes daily activities easier. Exercise has been proven to enhance walking and balance, which are crucial for mobility. Overall, regular exercise supports brain health and improves the quality of life for stroke survivors. ^{1 3 4 6 7}

Who Is on the Research Team?

Emily Byrne, BS

Principal Investigator

Baltimore VA Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke or TIA (mini-stroke), or are at risk due to high blood pressure, cholesterol issues, diabetes, or pre-diabetes. Participants must be able to understand the study and consent, get up from a chair on their own, have finished any post-stroke therapy if needed, and walk 30 feet without help.

Inclusion Criteria

Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent

I have finished all my scheduled physical therapy sessions after my stroke.

I can walk 30 feet on my own without help.

Exclusion Criteria

I have a history of leg pain due to poor blood flow.

I have high blood pressure readings over 190/110 on two different occasions.

I have had a heart attack or heart failure in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Testing

Baseline tests including walking and balance tests, cognitive function and mood tests, and MRI scans

1-2 weeks

1-2 visits (in-person)

Treatment

Participants engage in a supervised low intensity exercise class, 3 times per week for 6 months

6 months

72 visits (in-person)

Midpoint Assessment

Midpoint tests including walking and balance tests, cognitive function and mood tests

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in brain health and cognitive function post-treatment

4 weeks

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study tests how a 6-month low-intensity group exercise program affects fitness levels, walking ability, balance, and brain health in people with cardiovascular risks or past strokes/TIAs. Fitness and brain health will be measured before starting other MERCE exercises too.

How Is the Trial Designed?

Group I: Group Exercise Class Experimental Treatment 1 Intervention

6 month group balance/exercise class, three days a week - up to one hour. Exercise program includes walking around a track, bodyweight/balance exercises, and an obstacle course.

Group II: Testing Active Control 1 Intervention

Subjects enrolled in other MERCE exercise and robotics interventions will receive balance/walking tests, MRI with famous name recognition task, and cognitive testing pre and post their intervention.

Who Is Running the Clinical Trial?

Baltimore VA Medical Center

Lead Sponsor

Trials

33

Recruited

3,000+

University of Maryland

Collaborator

Trials

171

Recruited

325,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3263535/

Physical Activity in the Prevention and Treatment of Stroke The use of physical activity as a therapeutic strategy to maximise functional recovery in the rehabilitation of stroke survivors has a growing evidence base.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12434964/

Physical activity interventions for post-stroke cognitive recovery The findings revealed that compared with routine medical care, multi-modal exercise significantly improved cognitive function (SMD = −5.58, 95% ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1565118/full

Effects of high-intensity exercise on rehabilitation ... Conclusion: High-intensity exercise significantly improves 6MWT and BBS in stroke patients, but does not significantly affect TUG, VO2peak, ...

4. ahajournals.org ahajournals.org/doi/10.1161/str.0000000000000022

Physical Activity and Exercise Recommendations for ... This scientific statement provides an overview of the evidence on physical activity and exercise recommendations for stroke survivors.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2804371

Physical Activity Trajectories and Functional Recovery After ... Results of this study suggest that increased physical activity was associated with functional recovery 6 months after stroke.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11593633/

The Safety, Feasibility, and Efficacy of a Structured ... Conclusion: This study demonstrates that the comprehensive exercise program is sufficiently safe and valid for stroke rehabilitation patients.

7. bmj.com bmj.com/content/366/bmj.l5101

Physical Fitness Training in Patients with Subacute Stroke ... No safety concerns were reported for aerobic physical fitness training in the early subacute phase in two smaller previous studies comprising ...