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NCT05901675Recruiting

EMPOWER: Effects of Weight Loss and Exercise Post-stroke

Enhancing Mobility and Psychosocial Function in Obese Veterans Following Stroke Via Weight Loss and ExeRcise (EMPOWER)

Source: ClinicalTrials.gov · Last updated 15 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
130 (estimated)
First submitted
5 Jun 2023
Start date
7 Jul 2023
Primary completion date
31 Oct 2027
Lead sponsor
Medical University of South Carolina
Diseases
Obesity, Stroke
NCT number
NCT05901675

What you commit to

  • Study type: Interventional
  • Planned participants: 130
  • From 7 Jul 2023 to the primary completion date, 31 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking
  • preexisting neurological disorders, dementia or previous stroke

Other illness

  • history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
  • history of COPD or oxygen dependence
  • history of major head trauma
  • legal blindness or severe visual impairment
  • history of psychosis or other Axis I disorder that is primary
  • history of DVT or pulmonary embolism within 6 months
  • uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  • severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest
  • history of seizures or currently prescribed anti-seizure medications

Other

  • life expectancy \<1 yr
  • severe arthritis or other problems that limit passive ROM
  • current enrollment in a clinical trial to enhance motor recovery
  • persons with child-bearing potential.

Who the study is looking for

  • age 35-85
  • stroke at least 6-months prior
  • residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)
  • ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-0.8 m/s
  • body mass index (BMI) greater than 25
  • 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.

Age in the registry: 35 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
College of Health Professions
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.