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EMPOWER: Effects of Weight Loss and Exercise Post-stroke

RECRUITINGN/ASponsored by Medical University of South Carolina
Actively Recruiting
PhaseN/A
SponsorMedical University of South Carolina
Started2023-07-07
Est. completion2027-10
Eligibility
Age35 Years – 85 Years
Healthy vol.Accepted
Locations1 site

Summary

The prevalence of obesity among U.S. adults is \~40% and is projected to climb. It is well documented that obesity is associated with increased levels of disability as well as risk for numerous adverse health-related outcomes; including occurrence of stroke and all-cause mortality. Obesity is highly prevalent in stroke survivors (\~30-45% of stroke survivors have BMI\>30) and is associated with reductions in physical function and increased disability. Furthermore, neurological sequelae following stroke result in a myriad of residual impairments that contribute to significant reductions in physical activity, which further increase the risk for obesity. The alarmingly high (and increasing) rates of obesity amongst stroke survivors represents an area of critical clinical need and, despite an abundance of information regarding weight loss approaches in neurologically healthy individuals, there is a lack of information regarding the impact of intentional weight loss on overweight and obese survivors of stroke. Thus, the purpose of this study it investigate the effect of varying weight loss approaches on physical function and psychosocial outcomes in chronic stroke survivors.

Eligibility

Age: 35 Years – 85 YearsHealthy volunteers accepted
Inclusion Criteria:

1. age 35-85
2. stroke at least 6-months prior
3. residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)
4. ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-0.8 m/s
5. body mass index (BMI) greater than 25
6. provision of informed consent. All subjects who meet criteria for training must complete an exercise tolerance test and be cleared for participation by the study physician.

Exclusion Criteria:

1. unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking
2. history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
3. history of COPD or oxygen dependence
4. preexisting neurological disorders, dementia or previous stroke
5. history of major head trauma
6. legal blindness or severe visual impairment
7. history of psychosis or other Axis I disorder that is primary
8. life expectancy \<1 yr
9. severe arthritis or other problems that limit passive ROM
10. history of DVT or pulmonary embolism within 6 months
11. uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
12. severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest
13. history of seizures or currently prescribed anti-seizure medications
14. current enrollment in a clinical trial to enhance motor recovery
15. persons with child-bearing potential.

Conditions3

ObesityStrokeWeight Loss

Locations1 site

College of Health Professions
Charleston, South Carolina, 29425
Ewan R Williams, PhD843-792-3477williaew@musc.edu

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