Clinical trial

EMPOWER: Effects of Weight Loss and Exercise Post-stroke

Recruiting now · Not applicable · 1 countries · Registry ID NCT05901675

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age35 Years to 85 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Stroke

Full registry criteria

Inclusion Criteria: 1. age 35-85 2. stroke at least 6-months prior 3. residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34) 4. ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-0.8 m/s 5. body mass index (BMI) greater than 25 6. 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: 1. unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking 2. history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's 3. history of COPD or oxygen dependence 4. preexisting neurological disorders, dementia or previous stroke 5. history of major head trauma 6. legal blindness or severe visual impairment 7. history of psychosis or other Axis I disorder that is primary 8. life expectancy \<1 yr 9. severe arthritis or other problems that limit passive ROM 10. history of DVT or pulmonary embolism within 6 months 11. uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions 12. severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest 13. history of seizures or currently prescribed anti-seizure medications 14. current enrollment in a clinical trial to enhance motor recovery 15. persons with child-bearing potential.

Treatments and study arms

Lifestyle Management Program

Other

The program utilizes registered dietitians, exercise physiologists and psychologists and is designed to induce larger initial weight losses than traditional lifestyle change programs. The early part of the program provides a highly structured dietary intervention, which consists primarily of meal replacements provided to the participant as part of the program (shakes and nutrition bars). Gradually, as the program progresses, there is a shift towards a primarily food-based meal plan that leads to more moderate and sustainable weight loss. Throughout the program, participants attend weekly individual appointments that rotate among the clinical specialties (dietary and behavioral). The emphasis on lifestyle change means the goal is to help the participant learn to make healthy behavior changes that can be sustained long after completion of the program, thus enabling maintenance of a healthier weight.

Post-stroke Optimization of Walking using Explosive Resistance

Other

POWER training will take place over a 12-week period (3 sessions/week) with exercises including leg press, calf raises, and jump training, all performed at high concentric velocity, as well as trials of fast walking and functional movements.

Primary outcomes

Physical Function15 weeks

Participating in a lifestyle management program (DIET or DIET+Ex) will improve performance on the six-minute walk test (6MWT) compared to those in the waitlist control and DIET groups.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

College of Health Professions🇺🇸 Charleston, South Carolina, United States

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Ewan R Williams, PhDContact

Email · Call 8437923477

Chris Gregory, PhD, PTPrincipal Investigator