Weight Loss and ExeRcise for Post-stroke Veterans
Recruiting · NCT06322030 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
Exercise TrainingFOCUS-15 Lifestyle Management Program
What this trial is about
Weight loss interventions for neurologically health individuals have established benefits for improving physical and psychosocial function. The investigators believe that Veterans who have had a stroke would realize similar benefits and that the effects would be enhanced with concurrent exercise training. The investigators will study the effects of a 15-week lifestyle management program to determine if it can effectively improve some of the physical and psychosocial problems common in Veterans who have had a stroke.
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston, South Carolina, United States