EMPOWER: Effects of Weight Loss and Exercise Post-stroke

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

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• US Department of Veterans Affairs

  collaborator FED

• Medical University of South Carolina

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-07

Primary Completion

2027-10-31

Completion

2028-03-31

FDA Device

Yes

Countries

• United States

Study Locations