Actively Recruiting
EMPOWER: Effects of Weight Loss and Exercise Post-stroke
Led by Medical University of South Carolina · Updated on 2026-04-15
130
Participants Needed
1
Research Sites
242 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
U
US Department of Veterans Affairs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EMPOWER: Effects of Weight Loss and Exercise Post-stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 35 and 85 years
- Stroke occurred at least 6 months before joining
- Have residual weakness in the lower leg (Fugl-Meyer LE motor score less than 34)
- Able to walk without assistance or ankle-foot orthosis at speeds between 0.2 and 0.8 meters per second
- Body mass index (BMI) greater than 25
- Able and willing to provide informed consent and pass an exercise tolerance test approved by the study doctor
You will not qualify if you...
- Unable to walk at least 150 feet before stroke or have intermittent leg pain while walking
- History of heart failure, unstable heart rhythm, severe heart valve problems, chest pain, or breathing difficulty at rest or during daily activities
- History of chronic lung disease or need for oxygen therapy
- Other neurological disorders, dementia, or previous stroke besides the qualifying stroke
- History of major head injury
- Severe vision loss or legal blindness
- History of psychosis or major psychiatric disorders
- Life expectancy less than 1 year
- Severe arthritis or other conditions limiting joint movement
- Blood clots in legs or lungs within the past 6 months
- Uncontrolled diabetes with recent weight loss or severe insulin reactions
- Severe high blood pressure (systolic over 200 mmHg or diastolic over 110 mmHg at rest)
- History of seizures or current use of anti-seizure medication
- Currently enrolled in a motor recovery clinical trial
- Women who can become pregnant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
College of Health Professions
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
E
Ewan Willams, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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