EMPOWER: Effects of Weight Loss and Exercise Post-stroke

NCT05901675 | Recruiting FDA Device

• 2 other identifiers: Pro001208481I01RX004281-01A2
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

Weight Loss; Exercise

Outcome Measures

Primary Outcomes (1)

• Physical Function

  Participating in a lifestyle management program (DIET or DIET+Ex) will improve performance on the six-minute walk test (6MWT) compared to those in the waitlist control and DIET groups.

  15 weeks

Secondary Outcomes (1)

• Psychosocial Outcomes

  15 weeks

Study Arms (3)

DIET

EXPERIMENTAL

Focus-15 is a 15-week lifestyle change program developed and delivered by the Weight Management Center at the Medical University of South Carolina.

Other: Lifestyle Management Program

DIET+Exercise

EXPERIMENTAL

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.

Other: Lifestyle Management Program; Other: Post-stroke Optimization of Walking using Explosive Resistance

Wait-list Control

NO INTERVENTION

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 OTHER

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.

DIET; DIET+Exercise

Post-stroke Optimization of Walking using Explosive Resistance OTHER

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.

DIET+Exercise

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking
• history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
• history of COPD or oxygen dependence
• preexisting neurological disorders, dementia or previous stroke
• history of major head trauma
• legal blindness or severe visual impairment
• history of psychosis or other Axis I disorder that is primary
• life expectancy \<1 yr
• severe arthritis or other problems that limit passive ROM
• history of DVT or pulmonary embolism within 6 months
• uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
• severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest
• history of seizures or currently prescribed anti-seizure medications
• current enrollment in a clinical trial to enhance motor recovery
• persons with child-bearing potential.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

College of Health Professions

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Stroke; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Weight Changes; Behavior

Study Officials

• Chris Gregory, PhD, PT

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ewan Willams, PhD

CONTACT

843-792-3477; williaew@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Model Details: Participants will undergo the intervention within one arm alone.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: July 7, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)