EMPOWER: Effects of Weight Loss and Exercise Post-stroke
Recruiting · NCT05901675 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of South Carolina
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking
- 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
- preexisting neurological disorders, dementia or previous stroke
- history of major head trauma
- legal blindness or severe visual impairment
- history of psychosis or other Axis I disorder that is primary
- life expectancy \<1 yr
- severe arthritis or other problems that limit passive ROM
- 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
- current enrollment in a clinical trial to enhance motor recovery
- persons with child-bearing potential.
Where it is running
1 location listed across 1 US state.
- College of Health Professions - Charleston, South Carolina, United States