RECRUITING

Weight Loss and ExeRcise

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-01
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06322030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A diagnosis of stroke at least 6 months prior
  2. * BMI \> 30 kg/m2
  3. * Residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)
  4. * Ability to follow instructions, complete training and testing and to communicate exertion, pain and distress
  5. * Provision of informed consent
  6. * Individuals who meet inclusion criteria must complete an exercise tolerance test and be cleared for participation by the study cardiologist
  1. * Unable to ambulate at least 150 feet or experienced intermittent claudication while walking
  2. * Unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
  3. * Dementia
  4. * Life expectancy \<1 yr
  5. * History of DVT or pulmonary embolism within 6 months
  6. * Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  7. * Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest
  8. * Current enrollment in a rehabilitation trial to enhance motor or psychosocial recovery

Contacts and Locations

Study Contact

Sarah A Jackson, BA MA
CONTACT
(843) 789-6700
sarah.jackson@va.gov

Principal Investigator

Chris M Gregory, PhD
PRINCIPAL_INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC

Study Locations (Sites)

Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Chris M Gregory, PhD, PRINCIPAL_INVESTIGATOR, Ralph H. Johnson VA Medical Center, Charleston, SC

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

Study Start Date2024-05-01
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

  • obesity
  • weight loss
  • quality of life

Additional Relevant MeSH Terms

  • Stroke