Lifestyle Program + Exercise for Stroke

(EMPOWER Trial)

Overseen By Sarah A Jackson, BA MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Uncontrolled diabetes, Severe hypertension, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

99 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 15-week lifestyle program with exercise can improve physical and mental health issues in Veterans who have had a stroke. It will compare different approaches: waiting, exercise only (Exercise Training), following a diet plan, and combining diet with exercise. Veterans who experienced a stroke at least six months ago and have a BMI over 30 might be suitable candidates. Participants must be able to walk a short distance and follow instructions.

As an unphased trial, this study offers Veterans the opportunity to explore personalized lifestyle changes that could enhance their recovery journey.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that exercise is generally safe and beneficial for people recovering from a stroke. Studies have found that exercise can boost heart health, increase stamina, and improve life quality after a stroke. For instance, a stroke recovery program that included a modified heart health routine improved overall abilities and lowered death rates.

Regarding the 15-week lifestyle management program, similar programs have helped people lose 5% to 7% of their body weight, leading to better health. Although specific safety data for this program is limited, weight management programs are usually safe and aim to improve both physical and mental health.

Overall, exercise and lifestyle changes have demonstrated positive effects in other studies without major safety concerns. Most people handle these activities well, and they offer potential benefits for stroke recovery with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for stroke recovery because they offer a holistic approach, targeting both physical fitness and weight management. Unlike traditional treatments that often focus on medication and rehabilitation alone, the exercise training and diet components aim to improve overall health and well-being, potentially enhancing recovery outcomes. The exercise component is experimental and focuses on structured physical activity, which is known to aid in neuroplasticity and functional recovery. Meanwhile, the 15-week weight management program addresses lifestyle habits that can significantly impact stroke risk factors and recovery. By combining these elements, the trial hopes to discover more effective strategies for improving life post-stroke.

What evidence suggests that this trial's treatments could be effective for improving physical and psychosocial problems in Veterans who have had a stroke?

Research has shown that exercise, one of the treatments tested in this trial, can significantly aid stroke recovery. Studies have found that it improves walking ability and overall function, with many patients regaining 80-95% of their walking skills through regular exercise. Exercise also boosts heart health and quality of life. Another treatment arm in this trial, the Focus-15 lifestyle program, which combines diet and exercise, has been linked to a 5-7% weight loss and improved physical and mental well-being. These benefits suggest that exercise, alone or with dietary changes, can effectively support stroke recovery. ^{6 7 8 9 10}

Who Is on the Research Team?

Chris M Gregory, PhD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for Veterans who have experienced a stroke and are looking to lose weight. Participants should be interested in improving their physical and psychosocial health through a lifestyle management program combined with exercise training.

Inclusion Criteria

I was diagnosed with a stroke more than 6 months ago.

BMI > 30 kg/m2

I have weakness in my leg.

Exclusion Criteria

I can't walk 150 feet without pain or stopping.

I have been diagnosed with dementia.

Life expectancy <1 yr

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 management program including caloric restriction, with or without concurrent supervised exercise training

15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Training
• FOCUS-15 Lifestyle Management Program

Trial Overview

The study is testing the effectiveness of a 15-week FOCUS-15 Lifestyle Management Program paired with exercise training, specifically designed for individuals recovering from a stroke, aiming to enhance their physical function and overall well-being.

How Is the Trial Designed?

Group I: Exercise Experimental Treatment 1 Intervention

exercise training

Group II: Diet + Exercise Experimental Treatment 2 Interventions

15 week weight management program + exercise training

Group III: Diet Experimental Treatment 1 Intervention

15 week weight management program

Group IV: Control Active Control 1 Intervention

waitlist control

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A partnership was established between a healthcare system and a local fitness center to create a community-based exercise program for stroke survivors, addressing the lack of ongoing fitness opportunities after formal rehabilitation ends.

The program aims to provide affordable and safe exercise options, helping individuals poststroke maintain health and reduce the risk of recurrent strokes, while also detailing the referral process and outcomes for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extending the continuum of care poststroke: creating a partnership to provide a community-based wellness program. Rose, DK., Schafer, J., Conroy, C.[2016]

A home-based exercise program for stroke survivors, conducted over 8 weeks with 20 participants, showed significant improvements in motor function and balance compared to usual care, particularly in lower extremity function and gait velocity.

The study confirmed that implementing a randomized controlled trial for post-stroke exercise is feasible, although the effects on upper extremity function and overall health status were less clear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled pilot study of a home-based exercise program for individuals with mild and moderate stroke. Duncan, P., Richards, L., Wallace, D., et al.[2022]

This study will evaluate the effectiveness of an 8-week community-based exercise training program for 120 stroke patients after hospital discharge, focusing on improvements in muscle strength, cardiorespiratory fitness, and overall physical performance.

The trial aims to provide insights into how such exercise programs can enhance the quality of life and daily living activities for stroke survivors, potentially leading to better rehabilitation protocols in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for Community-Based Exercise Training after Discharge from Hospital-Based Stroke Rehabilitation: A Multicenter, Randomized, Parallel-Group, Double-Blind Controlled Pilot and Feasibility Trial. Kang, D., Park, J., Eun, SD.[2023]

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]

Integrating stroke survivors into a 12-week exercise-based cardiac rehabilitation program significantly improved their cardiovascular endurance, with participants increasing their 6-minute walk test distance by an average of 61.92 meters and improving functional strength as measured by the five times sit to stand test.

The majority of participants (83%) continued exercising after the program, indicating that exercise-based cardiac rehabilitation not only enhances physical function but also positively impacts the quality of life for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Survivors of Stroke Into Exercise-Based Cardiac Rehabilitation Improves Endurance and Functional Strength. Regan, EW., Handlery, R., Stewart, JC., et al.[2021]

Exercise is beneficial for stroke prevention as it positively influences risk factors like hypertension, diabetes, and obesity, although definitive large-scale trials are still needed to confirm these effects.

Post-stroke exercise is influenced by various factors, including self-efficacy and social support, and effective strategies to promote exercise include physician endorsement and structured programming, especially for older patients or those with cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for stroke prevention. Prior, PL., Suskin, N.[2022]

A systematic review of 37 randomized controlled trials (RCTs) found that while most studies reported the principle of specificity in exercise training for stroke survivors, only 13.5% included all key training principles, which limits the effectiveness of exercise interventions.

Patient adherence to prescribed exercise regimens was poorly reported, with only 8.1% of studies accounting for it, highlighting a significant gap in ensuring that stroke survivors follow through with their exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of principles of exercise training in sub-acute and chronic stroke survivors: a systematic review. Ammann, BC., Knols, RH., Baschung, P., et al.[2022]

In a study of 2310 patients undergoing a 12-week cardiac rehabilitation program, those with lower baseline exercise capacity (measured in METpeak) showed greater improvements in exercise capacity after rehabilitation, indicating that starting fitness levels influence responsiveness to training.

The amount and intensity of exercise training (ET) were significant predictors of post-rehabilitation exercise capacity, suggesting that personalized exercise prescriptions based on individual baseline fitness and other factors like age and BMI could enhance rehabilitation outcomes for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the role of the exercise training dose for changes in exercise capacity following a standard cardiac rehabilitation program. Iannetta, D., Rouleau, CR., Chirico, D., et al.[2023]

Lifestyle interventions, including both pharmacological and non-pharmacological methods, can significantly reduce the risk of recurrent strokes and cardiovascular events in patients who have experienced a transient ischemic attack or ischemic stroke.

While there is some evidence supporting increased exercise as part of a comprehensive care package leading to minor reductions in blood pressure, more high-quality trials with long-term follow-up are needed to better understand the full impact of lifestyle changes on cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle Interventions to Prevent Cardiovascular Events After Stroke and Transient Ischemic Attack. Vellipuram, AR., Rodriguez, G., Rawla, P., et al.[2020]

In a study of 200 patients with moderate to severe subacute stroke, those who underwent aerobic training experienced a higher rate of serious adverse events compared to those in the relaxation control group, with an incident rate ratio of 1.70.

The occurrence of serious adverse events in the aerobic training group was significantly influenced by pre-existing conditions such as diabetes mellitus and atrial fibrillation, indicating that these factors may increase risk and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. Rackoll, T., Nave, AH., Ebinger, M., et al.[2022]

In a study of 64 chronic stroke patients, dual task specific training significantly improved gait parameters such as step length, stride length, and cadence compared to conventional physical therapy.

Both treatment methods were effective, but dual task training showed greater benefits in enhancing ambulation, indicating it may be a more effective rehabilitation strategy for improving mobility in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of dual task specific training and conventional physical therapy in ambulation of hemiplegic stroke patients: A randomized controlled trial. Iqbal, M., Arsh, A., Hammad, SM., et al.[2022]

The study involved 50 stroke patients with hemiplegia, who were divided into a control group receiving conventional rehabilitation and a study group using a balance trainer alongside conventional therapy.

Results showed that the balance trainer significantly improved balance and postural control, as measured by the Berg Balance Scale and Timed-Up and Go Test, compared to conventional rehabilitation alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of exercises administered to stroke patients with balance trainer on rehabilitation results: a randomized controlled study. Ordahan, B., Karahan, AY., Basaran, A., et al.[2020]

Stroke survivors who participated in a stroke recovery program (SRP) that included modified cardiac rehabilitation experienced a four-fold reduction in 1-year all-cause mortality compared to nonparticipants, indicating a significant safety and efficacy benefit.

Participants in the SRP showed statistically significant improvements in functional outcomes across all measured domains and a 78% increase in cardiovascular performance, highlighting the program's effectiveness in enhancing recovery post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke Recovery Program with Modified Cardiac Rehabilitation Improves Mortality, Functional & Cardiovascular Performance. Cuccurullo, SJ., Fleming, TK., Zinonos, S., et al.[2022]

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