Recruiting

Weight Loss & Exercise

Sponsor:

Medical University of South Carolina

Code:

NCT05901675

Conditions

Obesity

Stroke

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Lifestyle Management Program

Post-stroke Optimization of Walking using Explosive Resistance

Study Details

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.

Conditions

Obesity

Stroke

Study ID

NCT05901675

Start date

Jul 7, 2023

Status verified date

Apr, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

Lifestyle Management Program

The program utilizes registered dietitians, exercise physiologists and psychologists and is designed to induce larger initial weight losses than traditional lifestyle change programs. The early part of the program provides a highly structured dietary intervention, which consists primarily of meal replacements provided to the participant as part of the program (shakes and nutrition bars). Gradually, as the program progresses, there is a shift towards a primarily food-based meal plan that leads to more moderate and sustainable weight loss. Throughout the program, participants attend weekly individual appointments that rotate among the clinical specialties (dietary and behavioral). The emphasis on lifestyle change means the goal is to help the participant learn to make healthy behavior changes that can be sustained long after completion of the program, thus enabling maintenance of a healthier weight.

Post-stroke Optimization of Walking using Explosive Resistance

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.

Primary outcome measure

  • Physical Function [ Time Frame: 15 weeks ]

Central Contacts and Locations

Central contacts

Ewan Willams, PhD

843-792-3477williaew@musc.edu

Locations

College of Health Professions

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Ewan R Williams, PhD

8437923477williaew@musc.edu

Principal Investigator:

Chris Gregory, PhD, PT

More Information

Sponsor

Medical University of South Carolina

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • Weight Loss
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-04-15.