Actively Recruiting

Phase Not Applicable
Age: 35Years - 85Years
All Genders
NCT05901675

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

Age: 35Years - 85Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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EMPOWER: Effects of Weight Loss and Exercise Post-stroke | DecenTrialz