Weight loss and exercise program for stroke survivors
Enhancing Mobility and Psychosocial Function in Obese Veterans Following Stroke Via Weight Loss and ExeRcise (EMPOWER)
This study is testing a weight loss and exercise program to see if it can help stroke survivors who are overweight or obese improve their physical function and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 35 Years to 85 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05901675 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of a lifestyle management program and a specialized exercise regimen on weight loss and physical function in stroke survivors who are overweight or obese. Participants will be individuals aged 35-85 who have experienced a stroke at least six months prior and have residual mobility impairments. The program focuses on optimizing walking abilities through explosive resistance training while promoting weight loss to improve overall health outcomes. The study seeks to fill a critical gap in understanding how intentional weight loss can benefit this specific population.
Who should consider this trial
Good fit: Ideal candidates for this study are stroke survivors aged 35-85 with a BMI greater than 25 and residual lower extremity paresis.
Not a fit: Patients who are unable to ambulate without assistance or have severe preexisting health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve mobility and reduce obesity-related health risks in stroke survivors.
How similar studies have performed: While there is extensive research on weight loss in neurologically healthy individuals, this approach specifically targeting post-stroke obesity is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charleston, South Carolina
- College of Health Professions — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Chris Gregory, PhD, PT — Medical University of South Carolina
- Study coordinator: Ewan Willams, PhD
- Email: williaew@musc.edu
- Phone: 843-792-3477
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.