EMPOWER: Effects of Weight Loss and Exercise Post-stroke

Conditions

• Obesity
• Stroke

Eligibility Criteria

Sex

ALL

Age

35 Years - 85 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Jul 7, 2023

Status verified

Apr 2026

Primary completion

Oct 31, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

130 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Physical Function [ Time Frame: 15 weeks ]

Central Contacts

• Ewan Willams, PhD
  843-792-3477
  [email protected]

Locations (1)

Find similar trials in Charleston, SC

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