RECRUITING

EMPOWER: Effects of Weight Loss and Exercise Post-stroke

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

The prevalence of obesity among U.S. adults is \~40% and is projected to climb. It is well documented that obesity is associated with increased levels of disability as well as risk for numerous adverse health-related outcomes; including occurrence of stroke and all-cause mortality. Obesity is highly prevalent in stroke survivors (\~30-45% of stroke survivors have BMI\>30) and is associated with reductions in physical function and increased disability. Furthermore, neurological sequelae following stroke result in a myriad of residual impairments that contribute to significant reductions in physical activity, which further increase the risk for obesity. The alarmingly high (and increasing) rates of obesity amongst stroke survivors represents an area of critical clinical need and, despite an abundance of information regarding weight loss approaches in neurologically healthy individuals, there is a lack of information regarding the impact of intentional weight loss on overweight and obese survivors of stroke. Thus, the purpose of this study it investigate the effect of varying weight loss approaches on physical function and psychosocial outcomes in chronic stroke survivors.

Official Title

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

Quick Facts

Study Start:2023-07-07
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05901675

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:35 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. age 35-85
  2. 2. stroke at least 6-months prior
  3. 3. residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)
  4. 4. ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-0.8 m/s
  5. 5. body mass index (BMI) greater than 25
  6. 6. provision of informed consent. All subjects who meet criteria for training must complete an exercise tolerance test and be cleared for participation by the study physician.
  1. 1. unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking
  2. 2. history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
  3. 3. history of COPD or oxygen dependence
  4. 4. preexisting neurological disorders, dementia or previous stroke
  5. 5. history of major head trauma
  6. 6. legal blindness or severe visual impairment
  7. 7. history of psychosis or other Axis I disorder that is primary
  8. 8. life expectancy \<1 yr
  9. 9. severe arthritis or other problems that limit passive ROM
  10. 10. history of DVT or pulmonary embolism within 6 months
  11. 11. uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  12. 12. severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest
  13. 13. history of seizures or currently prescribed anti-seizure medications
  14. 14. current enrollment in a clinical trial to enhance motor recovery
  15. 15. persons with child-bearing potential.

Contacts and Locations

Study Contact

Ewan Willams, PhD
CONTACT
843-792-3477
williaew@musc.edu

Principal Investigator

Chris Gregory, PhD, PT
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

College of Health Professions
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Chris Gregory, PhD, PT, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

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 Date2023-07-07
Study Completion Date2028-03

Study Record Updates

Study Start Date2023-07-07
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • Weight Loss
  • Exercise

Additional Relevant MeSH Terms

  • Obesity
  • Stroke