RecruitingNot applicable

Weight Loss and ExeRcise for Post-stroke Veterans

Enhancing Mobility and Psychosocial Function in Obese Veterans Following Stroke Via Weight Loss and ExeRcise (EMPOWER)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a 15-week program for weight loss and exercise in Veterans who have had a stroke. It will look at whether the program helps with physical problems, feelings, and social well-being.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Had a stroke at least 6 months ago.
  • Have a body mass index (BMI) over 30, a measure of weight compared with height.
  • Still have leg weakness from the stroke, with a leg movement test score below 34.
  • Can follow directions, complete training and tests, and report effort, pain, and distress.
  • Agree to take part after learning about the study.
  • Complete an exercise test and get approval from the study's heart doctor.

Who can't join

  • Cannot walk at least 150 feet, or have leg pain that comes and goes while walking due to poor blood flow.
  • Have an unstable heartbeat, thickened heart muscle, a severely narrowed heart valve, or chest pain or shortness of breath at rest or during daily tasks.
  • Have dementia, a condition that affects memory and thinking.
  • Are expected to live less than 1 year.
  • Had a blood clot in a deep vein or the lungs within the past 6 months.
  • Have uncontrolled diabetes with recent weight loss, a diabetes-related coma, or frequent reactions to insulin.
  • Have very high blood pressure at rest: top number over 200 and bottom number over 110.
  • Are currently in another recovery study aimed at improving movement, feelings, or social well-being.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

SC