RECRUITING

Exercise Primed Stroke Rehabilitation

Conditions

Stroke rehabilitation exercise brain-derived neurotrophic factor upper extremity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Priming the Rehabilitation Engine: Aerobic Exercise as the Fuel to Spark Behavioral Improvements in Stroke

Quick Facts

Study Start:2021-07-01

Study Completion:2025-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04877444

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Ryan E Ross, PhD

CONTACT

(843) 792-3477

Ryan.Ross2@va.gov

Principal Investigator

Ryan E Ross, PhD

PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center, Charleston, SC

Study Locations (Sites)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Ryan E Ross, PhD, PRINCIPAL_INVESTIGATOR, Ralph H. Johnson VA Medical Center, Charleston, SC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-01

Study Completion Date2025-07-30

Study Record Updates

Study Start Date2021-07-01

Study Completion Date2025-07-30

Terms related to this study

Keywords Provided by Researchers

rehabilitation
exercise
brain-derived neurotrophic factor
upper extremity

Additional Relevant MeSH Terms

Stroke