Exercise Primed Stroke Rehabilitation

Recruiting now · Early Phase 1

Conditions studied: Stroke

In brief

Stroke is a leading cause of disability in the U.S. and many Veteran stroke survivors live with severe disability. Despite recent advances in rehabilitation treatments many stroke survivors have persistent physical and mental difficulties such as reduced physical and cognitive function and depression. Developing innovative treatments that address these problems is necessary to improve long-term outcomes for stroke survivors. Aerobic exercise (AEx) can improve physical and cognitive function, and reduce depression. Additionally, AEx may enhance physical rehabilitation by making the brain more receptive to, and consequently improving the response to an intervention. Therefore, combining AEx with physical rehabilitation has the potential to improve multiple aspects of stroke recovery. This study will examine the effect of combining AEx with physical rehabilitation on physical and mental function in stroke survivors. By gaining a better understanding of the effects of this combined intervention the investigators aim to advance the rehabilitative care of Veteran stroke survivors.

Key facts

Study ID

NCT04877444

Run by

VA Office of Research and Development

People needed

40

Starts

2021-07-01

Expected to finish

2027-01-31

Last updated by the study team

2026-01-09

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• experienced unilateral stroke at least 6 months prior;
• voluntarily shoulder flexion of the affected arm 20 degrees with simultaneous elbow extension 10 degrees;
• moderate arm movement impairment (UE Fugl-Meyer Assessment > 21 but < 52 points;
• passive range of motion in paretic shoulder, elbow, wrist, thumb and fingers within 20 degrees of normal;
• 50-90 years of age;
• ability to communicate as per the therapists' judgement at baseline testing;
• ability to complete and pass an exercise tolerance test; 8) Box \& Block test score of at least 3 blocks in 60 seconds with the affected arm.

You may not qualify if…

• lesion in brainstem/cerebellum as these may interfere with visual-perceptual/cognitive skills needed for motor re-learning;
• presence of other neurological disease that may impair motor learning skills;
• orthopedic condition or impaired corrected vision that alters reaching ability (e.g., prior rotator cuff tear without full recovery);
• paretic arm pain that interferes with reaching;
• unable to understand or follow 3-step directions;
• severe cognitive impairment (MoCA score 17);
• severe aphasia;
• inability to read English,
• history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's;
• Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest;
• History of COPD or oxygen dependence;
• History of DVT or pulmonary embolism within 6 months;
• Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
• UBACC score < 15; and for brain stimulation procedures only:
• electronic or metallic implants;
• history of seizures;
• women of child bearing potential.

Where it is running

• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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