Weight Loss and Exercise for Stroke Survivors

(EMP Trial)

Overseen By Ewan Willams, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Anti-seizure medications

Disqualifiers: Congestive heart failure, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 15 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 the Weight Loss and Exercise program for stroke survivors safe?

The program is generally safe, as no adverse events were reported in a study where participants felt safe to exercise and showed high satisfaction. ^{1 2 3 4 5}

How is the Lifestyle Management Program treatment different for stroke survivors?

The Lifestyle Management Program is unique because it combines physical activity and dietary changes specifically tailored for stroke survivors, addressing their unique physiological and cognitive needs, unlike standard treatments that may not focus on these aspects. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Lifestyle Management Program, Post-stroke Optimization of Walking using Explosive Resistance for stroke survivors?

Research shows that lifestyle programs focusing on exercise and diet can help stroke survivors improve their health and reduce the risk of another stroke. Programs that include supervised exercise and education have been found to be feasible, well-received, and beneficial, with participants showing improvements in physical activity and health measures. ^{1 2 5 11 12}

Who 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

Provision of informed consent

I am between 35 and 85 years old.

I have weakness in my leg (Fugl-Meyer score <34).

Exclusion Criteria

You are currently taking part in a study to improve movement recovery.

I have diabetes with recent weight loss, coma, or frequent insulin issues.

I have a history of serious heart conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 15-week lifestyle change program focusing on weight loss, with or without supervised exercise training

15 weeks

Weekly sessions

Exercise Training

Participants in the DIET+Exercise group receive 12 weeks of supervised high-velocity, high-intensity lower extremity resistance training

12 weeks

3 sessions per week

Follow-up

Participants are monitored for improvements in physical and psychosocial function after the intervention

4 weeks

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?

Group I: DIET+Exercise Experimental Treatment 2 Interventions

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.

Group II: DIET Experimental Treatment 1 Intervention

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

Group III: Wait-list Control Active Control 1 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.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Published Research Related to This Trial

A systematic review of 11 randomized controlled trials (RCTs) on home physical activity interventions for post-stroke patients revealed poor reporting quality, with only a median of 7 out of 39 CONSORT items fully reported.

Most studies relied on adherence diaries to assess physical activity, but there was a lack of objective adherence measurement methods, highlighting the need for improved reporting standards and more accurate assessment techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing adherence to physical activity programs post-stroke at home: A systematic review of randomized controlled trials. Lu, R., Lloyd-Randolfi, D., Jones, H., et al.[2021]

A 12-week lifestyle medicine program for poststroke patients led to significant improvements in cardiovascular fitness, with participants increasing their VO2 max by nearly 2 mL O2/min/kg, indicating enhanced aerobic capacity.

The program also resulted in notable reductions in systolic blood pressure among hypertensive participants, with decreases of approximately 9.7 mm Hg when supine and 11.1 mm Hg when standing, suggesting potential benefits for cardiovascular health post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Lifestyle Medicine Program Improves Fitness, Function, and Blood Pressure in Poststroke Veteran Cohort: A Pilot Study. Krauss, J., Frates, E., Parekh, M., et al.[2022]

The Group Lifestyle Balance (GLB-CVA) intervention is a modified 12-month weight loss program specifically designed for stroke survivors, addressing their unique needs and aiming to improve weight and health outcomes.

This randomized controlled trial (RCT) plans to enroll 64 patients over 18 months to evaluate the efficacy of GLB-CVA compared to a waitlist control group, contributing valuable insights into effective weight loss strategies for individuals post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial. Driver, S., Swank, C., Froehlich-Grobe, K., et al.[2020]

Progressive strength and low-intensity aerobic exercise programs lasting 3 to 6 months can significantly improve motor function, strength, balance, and overall fitness in stroke survivors without worsening spasticity.

Increasing access to community-based physical activity programs is crucial for preventing deconditioning and enhancing the quality of life for individuals recovering from a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adapted exercise important after stroke. Acute and long-term effects of different training programs]. Engardt, M., Grimby, G.[2017]

Citations

1. Korea (South) pubmed.ncbi.nlm.nih.gov

[The lifestyle modification coaching program for secondary stroke prevention]. [2013]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating Feasibility of a Secondary Stroke Prevention Program. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Does participation in standardized aerobic fitness training during inpatient stroke rehabilitation promote engagement in aerobic exercise after discharge? A cohort study. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Assessing adherence to physical activity programs post-stroke at home: A systematic review of randomized controlled trials. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Interventions to promote long-term participation in physical activity after stroke: a systematic review of the literature. [2022]

7. England pubmed.ncbi.nlm.nih.gov

'Masterstroke: a pilot group stroke prevention program for community dwelling stroke survivors'. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Lifestyle Medicine Program Improves Fitness, Function, and Blood Pressure in Poststroke Veteran Cohort: A Pilot Study. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Promoting physical activity after stroke via self-management: a feasibility study. [2019]

11. Sweden pubmed.ncbi.nlm.nih.gov

[Adapted exercise important after stroke. Acute and long-term effects of different training programs]. [2017]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Partial Meal Replacement for Weight Loss after Stroke: Results of a Pilot Clinical Trial. [2023]