Weight loss and exercise program for stroke survivors
Enhancing Mobility and Psychosocial Function in Obese Veterans Following Stroke Via Weight Loss and ExeRcise (EMPOWER)
NA · VA Office of Research and Development · NCT06322030
This study tests whether a 15-week weight loss and exercise program can help obese Veterans who have had a stroke feel better and recover more effectively.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06322030 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of a 15-week lifestyle management program aimed at promoting weight loss and exercise among obese Veterans who have experienced a stroke. The program combines caloric restriction with supervised exercise training to enhance physical and psychosocial function. The study aims to determine if these interventions can improve recovery outcomes compared to control subjects. By focusing on the unique needs of stroke survivors, the trial seeks to fill a gap in existing research on weight loss benefits in this population.
Who should consider this trial
Good fit: Ideal candidates include obese Veterans with a stroke diagnosis at least 6 months prior and residual lower extremity paresis.
Not a fit: Patients who are unable to ambulate at least 150 feet or have severe cardiovascular or metabolic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and functional abilities of obese Veterans who have suffered a stroke.
How similar studies have performed: While weight loss interventions have been successful in neurologically healthy individuals, this specific approach for stroke survivors is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A diagnosis of stroke at least 6 months prior * BMI \> 30 kg/m2 * Residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34) * Ability to follow instructions, complete training and testing and to communicate exertion, pain and distress * Provision of informed consent * Individuals who meet inclusion criteria must complete an exercise tolerance test and be cleared for participation by the study cardiologist Exclusion Criteria: * Unable to ambulate at least 150 feet or experienced intermittent claudication while walking * Unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's * Dementia * Life expectancy \<1 yr * 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 * Current enrollment in a rehabilitation trial to enhance motor or psychosocial recovery
Where this trial is running
Charleston, South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Chris M Gregory, PhD — Ralph H. Johnson VA Medical Center, Charleston, SC
- Study coordinator: Sarah A Jackson, BA MA
- Email: sarah.jackson@va.gov
- Phone: (843) 789-6700
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.
Conditions: Stroke, obesity, weight loss, quality of life