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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 85
Healthy Volunteers: f
View:

• age 35-85

• stroke at least 6-months prior

• residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)

• ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-0.8 m/s

• body mass index (BMI) greater than 25

• 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.

Locations
United States
South Carolina
College of Health Professions
RECRUITING
Charleston
Contact Information
Primary
Ewan Willams, PhD
williaew@musc.edu
843-792-3477
Time Frame
Start Date: 2023-07-07
Estimated Completion Date: 2028-03
Participants
Target number of participants: 130
Treatments
Experimental: DIET
Focus-15 is a 15-week lifestyle change program developed and delivered by the Weight Management Center at the Medical University of South Carolina.
Experimental: DIET+Exercise
As above with, the addition of supervised exercise. The investigators developed an innovative rehabilitation approach, Post-stroke Optimization of Walking using Explosive Resistance (POWER) training; a high-velocity, high-intensity lower extremity resistance training intervention that improves post-stroke muscular and locomotor function. POWER training will take place over a 12-week period (3 sessions/week) with exercises including leg press, calf raises, and jump training, all performed at high concentric velocity, as well as trials of fast walking and functional movements.
No_intervention: Wait-list Control
Participants will undergo pre-, post- and follow-up testing but will not partake in any intervention during the same timeframe as those listed in the other arms. Participants will have the opportunity to be enrolled in one of the other arms once they have completed the WLC group timeframe.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: US Department of Veterans Affairs

This content was sourced from clinicaltrials.gov