NCT05901675 EMPOWER: Effects of Weight Loss and Exercise Post-stroke
| NCT ID | NCT05901675 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-07-07 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2023-07-07 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. age 35-85 2. stroke at least 6-months prior 3. residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34) 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. body mass index (BMI) greater than 25 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. Exclusion Criteria: 1. unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking 2. history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's 3. history of COPD or oxygen dependence 4. preexisting neurological disorders, dementia or previous stroke 5. history of major head trauma 6. legal blindness or severe visual impairment 7. history of psychosis or other Axis I disorder that is primary 8. life expectancy \<1 yr 9. severe arthritis or other problems that limit passive ROM 10. history of DVT or pulmonary embolism within 6 months 11. uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions 12. severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest 13. history of seizures or currently prescribed anti-seizure medications 14. current enrollment in a clinical trial to enhance motor recovery 15. persons with child-bearing potential.
Contact & Investigator
Chris Gregory, PhD, PT
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT05901675 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 85 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05901675 currently recruiting?
Yes, NCT05901675 is actively recruiting participants. Contact the research team at williaew@musc.edu for enrollment information.
Where is the NCT05901675 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05901675 clinical trial?
NCT05901675 is sponsored by Medical University of South Carolina. The principal investigator is Chris Gregory, PhD, PT at Medical University of South Carolina. The trial plans to enroll 130 participants.
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