Weight Loss and Exercise for Stroke Survivors
(EMP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different weight loss strategies can improve physical and emotional well-being in stroke survivors. Participants will either follow a diet plan, combine the diet with a special exercise program designed to boost leg strength and walking ability (part of the Lifestyle Management Program), or be placed on a waitlist before starting one of these methods. The trial aims to determine which approach most effectively helps stroke survivors become fitter and feel better. It suits individuals who had a stroke at least six months ago, can walk without assistance, and have a BMI over 25. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could enhance recovery strategies for stroke survivors.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are currently prescribed anti-seizure medications, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lifestyle programs for stroke survivors are generally safe. One study found that a structured weight-loss program with meal replacements helped participants lose weight without major side effects. Another review highlighted that lifestyle changes are a key way to prevent further strokes and are well-tolerated by participants.
For the exercise component, known as POWER training, studies have shown it is safe for stroke survivors. Research indicates that this program can improve muscle strength and walking ability without causing injuries or health problems. Exercise programs like this are considered safe and beneficial for stroke patients.
In summary, both the lifestyle changes and exercise program in the trial have been shown to be safe in previous studies. They are well-tolerated by participants and help improve health outcomes.12345Why are researchers excited about this trial?
Researchers are excited about the Lifestyle Management Program for stroke survivors because it combines innovative approaches to improve recovery. Unlike standard care for stroke recovery, which often focuses on medication and basic physical therapy, this program integrates a structured diet plan with a unique rehabilitation method called POWER training. POWER training is distinctive due to its focus on high-velocity, high-intensity exercises, like leg presses and jump training, which aim to enhance post-stroke muscular and locomotor function. This approach could lead to more significant improvements in mobility and quality of life for stroke survivors compared to traditional methods.
What evidence suggests that this trial's treatments could be effective for stroke survivors?
Research shows that lifestyle programs focusing on diet and exercise can help stroke survivors lose weight and improve their health. This trial includes a "DIET" arm, where participants engage in a lifestyle management program focusing on diet alone, and a "DIET+Exercise" arm, which combines diet with the Post-stroke Optimization of Walking using Explosive Resistance (POWER) training. Studies have consistently shown that these programs can lead to a 5% to 7% weight loss, significantly enhancing physical function. Both diet alone and diet combined with exercise improve walking ability, as measured by the six-minute walk test.
Regarding exercise, the POWER training program, part of the "DIET+Exercise" arm in this trial, greatly increases strength in stroke survivors. Participants in previous studies saw a 54% improvement in their weaker limbs and a 57% improvement in their stronger limbs. This type of training also helps improve overall movement and function, making it a promising way to aid recovery after a stroke.35678Who Is on the Research Team?
Chris Gregory, PhD, PT
Principal Investigator
Medical University of South Carolina
Are You a Good Fit for This Trial?
This trial is for chronic stroke survivors aged 35-85 with a BMI over 25, who can walk unassisted at certain speeds and have some lower extremity weakness. They must pass an exercise test and get clearance from the study physician. Excluded are those with severe heart conditions, visual impairments, uncontrollable high blood pressure, seizure history, other neurological issues or major health problems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 15-week lifestyle change program focusing on weight loss, with or without supervised exercise training
Exercise Training
Participants in the DIET+Exercise group receive 12 weeks of supervised high-velocity, high-intensity lower extremity resistance training
Follow-up
Participants are monitored for improvements in physical and psychosocial function after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Lifestyle Management Program
- Post-stroke Optimization of Walking using Explosive Resistance
Trial Overview
The EMPOWER trial is testing two weight loss approaches in overweight stroke survivors: a Lifestyle Management Program and a Post-stroke Optimization of Walking program using explosive resistance training to improve physical function and psychosocial outcomes.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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.
Focus-15 is a 15-week lifestyle change program developed and delivered by the Weight Management Center at the Medical University of South Carolina.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
US Department of Veterans Affairs
Collaborator
Published Research Related to This Trial
Citations
Weight Loss After Stroke Through an Intensive Lifestyle ...
As such, the GLB program was chosen because of data consistently demonstrating 5% to 7% weight loss, evidence of success in other disability ...
EMPOWER: Effects of Weight Loss and Exercise Post-stroke
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 ...
Enhancing Mobility and Psychosocial Function in Stroke ...
Multicomponent lifestyle interventions appear to be a feasible modality to achieve clinically meaningful (>5%) weight loss in chronic stroke survivors.
Weight Loss and Exercise for Stroke Survivors (EMP Trial)
Research shows that lifestyle programs focusing on exercise and diet can help stroke survivors improve their health and reduce the risk of another stroke.
Weight Management Post-Stroke: A Scoping Review
Results: All studies reported significant weight loss and/or improvement in body composition among chronic stroke survivors. In addition, all ...
Randomized controlled pilot study of a SystemCHANGE ...
The central hypothesis of the study is that the SystemCHANGE™ intervention will help overweight and obese stroke survivors lose 5% of their body ...
Efficacy of an evidence-based telehealth-delivered weight ...
An evidence-based, scalable telehealth weight-loss program designed for people post stroke that clinicians and community workers can use to increase ...
Updated Perspectives on Lifestyle Interventions as ...
This review underlines the benefits of adhering to lifestyle modifications as the most effective secondary stroke prevention measure.
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