RECRUITING
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Weight Loss and ExeRcise
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.
Conditions:
🦠 Stroke
🗓️ Study Start (Actual) 1 May 2024
🗓️ Primary Completion (Estimated) 31 December 2027
✅ Study Completion (Estimated) 31 March 2028
👥 Enrollment (Estimated) 99
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Charleston, South Carolina, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 40 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 March 2024
  • First Submitted that Met QC Criteria 13 March 2024
  • First Posted 20 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 May 2024
  • Last Update Posted 8 May 2024
  • Last Verified May 2024
I'm interested ...!!