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NCT07799987
Self-Managed Exercise in Chronic Stroke
Conditions: Stroke
Sex: All
Ages: 18 Years – 89 Years
Healthy volunteers: No
Phase: NA
Enrollment: 23
Sponsor: University of Florida
Location: Malcom Randall VAMC Gainesville Florida
Summary
This pilot study will assess the feasibility of a novel intervention to promote long-term self-managed exercise for post-stroke community-dwelling individuals. We will test a multi-disciplinary intervention that includes Behavioral Management as an adjuvant to exercise on the ability of post-stroke community-dwelling individuals to self-manage sustained Physical Activity. In Phase I, participants will engage in a clinician-led 18-session in-home intervention of respiratory, strengthening and cardiovascular exercise and a weekly 1-hour virtual Behavioral Management Program of motivational interviewing and goal setting related to participants' Phase I exercise program. A waist-worn sensor will provide minutes/day in activity and sedentary behavior. Phase II will begin following the 18-session guided program. Participants will be followed for two-months with weekly check-ins of behavioral management program and for exercise progression. Participants will continue to wear the activity monitor with the goal to independently attain 150 minutes of Moderate to Vigorous Physical Activity/week. This proposed Behavioral Management Program (BMP) + Exercise Program (EP) package has the potential to decrease cardiovascular risk and secondary stroke in those living with chronic stroke. The expected outcome of this proposal will provide an evidence-based intervention to sustain the health of those living with post-stroke disability. The impact of this proposal may have far-reaching effects; this multi-disciplinary program could readily be adapted for others living with a chronic illness to ensure optimal health and quality of life in the presence of physical disability.
Eligibility Criteria
Inclusion Criteria:
1. -diagnosis of stroke \> six months \< 10 years since stroke onset,
2. \> 18 years; \ 19,
4. able to stand from chair and remain standing independently,
5. able to walk 20 feet without physical assistance,
6. no other neurological diagnosis,
7. no history of intermittent claudication,
8. no angina at rest or with minimal exertion,
9. no history of chronic obstructive pulmonary disease,
10. not currently receiving physical rehabilitation services,
11. ability to express pain, fatigue or the need for assistance,
12. ability to follow a three-step command or mimic exercises
13. approval from primary care physician to participate
Exclusion Criteria:
1. a neurologic condition other than stroke, i.e. Parkinson's Disease, multiple sclerosis,
2. severe, functional limiting arthritis,
3. orthopedic condition that limits mobility,
4. severe weight-bearing pain,
5. current participation in other physical rehabilitation services or exercise programs,
6. Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within the past year, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living). Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded,
7. Severe hypertension: with systolic \> 200 mmHg and diastolic \> 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg,
8. use of supplemental oxygen at baseline,
9. severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 or higher, indicating FEV1\
Source: ClinicalTrials.gov (NCT07799987). StuddyBuddy aggregates publicly available trial information.