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Exercise for Stroke Recovery (EBH Trial)

N/A

Recruiting

Research Sponsored by Baltimore VA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to walk 30 feet without human assistance

Able to rise from a chair unaided

Must not have

Clinical history of peripheral arterial obstructive disorder with claudication

Clinical history of poorly controlled hypertension (>190/110), measured on at least two separate occasions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine the impact of a 6 month, low intensity group exercise class on fitness, walking, balance, and brain health in individuals who have had a prior stroke or TIA, or who have vascular disease risk factors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves exercise as an intervention rather than medication there may not be traditional side effects; however participants might experience muscle soreness or fatigue related to physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk 30 feet on my own without help.

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I can get up from a chair without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a history of unstable chest pain.

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I have a history of serious heart valve problems.

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I have major depression that has not been treated.

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I have a history of lung or kidney failure.

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I have a condition that limits my ability to exercise due to pain or muscle issues.

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I have a severe communication disorder that affects my understanding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in executive function

Electroencephalography

Change from baseline in cortical thickness

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group Exercise ClassExperimental Treatment1 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: TestingActive Control1 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.

0 / 10Eligibility criteria met