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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The risk of stroke and vascular dementia is high in individuals who have had a prior stroke or TIA, and in those who have vascular disease risk factors, such as high blood pressure, abnormal cholesterol, diabetes or pre-diabetes. These vascular risk factors can improve with exercise. This study will examine the impact of a 6 month, low intensity group exercise class on fitness, walking, balance, and brain health. This study will also collect fitness, walking, balance, and brain health outcome measures at baseline and post all other MERCE exercise and robotics interventions.

Research Team

Emily Byrne, BS

Principal Investigator

Baltimore VA Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+