EMPOWER: Effects of Weight Loss and Exercise Post-stroke (NCT05901675) | Clinical Trial Compass
RecruitingNot Applicable
EMPOWER: Effects of Weight Loss and Exercise Post-stroke
United States130 participantsStarted 2023-07-07
Plain-language 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.
Who can participate
Age range35 Years ā 85 Years
SexALL
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Inclusion criteria
ā. age 35-85
ā. stroke at least 6-months prior
ā. residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)
ā. ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-0.8 m/s
ā. body mass index (BMI) greater than 25
ā. 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
ā. unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking
ā. history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's