Resistance Training + Protein for Stroke Recovery

(REPS Trial)

Overseen By Frederick M Ivey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Oral steroids

Disqualifiers: Dementia, Untreated depression, Uncontrolled diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

93 Participants Needed

Trial Summary

What is the purpose of this trial?

Stroke survivors experience severe muscle wasting during the chronic phase of recovery, with implications for strength, function and general health. Although resistive exercise training effectively combats this problem, it is unknown whether sub-optimal protein intake limits the observed gains in skeletal muscle growth. Skeletal muscle adaptations may occur when resistive training (RT) is combined with nutritional therapy in the form of post- exercise protein consumption. This study would be the first to directly compare RT+protein supplementation to RT+placebo (same calories as protein supplement) in those with chronic hemiparesis caused by stroke, providing evidence-based rationale for combination therapy in the clinical care of this population.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking oral steroids, you would be excluded from participating.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking oral steroids, you may not be eligible to participate.

What data supports the idea that Resistance Training + Protein for Stroke Recovery is an effective treatment?

The available research shows that resistance training is effective in promoting functional independence after a stroke. It improves muscle strength, self-reported function, and reduces disability in long-term stroke survivors. Additionally, when combined with aerobic exercises, it enhances mobility and physical activity levels. These findings suggest that Resistance Training + Protein is a beneficial treatment for stroke recovery. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for stroke recovery?

Research shows that resistance training can help improve strength, function, and independence in people recovering from a stroke. Combining resistance training with other exercises according to guidelines also enhances mobility and physical activity levels in stroke patients. ^{1 2 3 4 5}

What safety data exists for resistance training and protein supplementation in stroke recovery?

The available research indicates that resistance training, including progressive resistance training (PRT), is generally safe for stroke survivors, even within the first 3 months post-stroke. A systematic review found no significant increase in adverse events associated with PRT. Additionally, dynamic resistance training has shown improvements in physical function and hemodynamic parameters without reported safety concerns. However, there is limited specific data on the safety of combining resistance training with protein supplementation in stroke recovery. ^{2 6 7 8 9}

Is resistance training safe for stroke recovery?

Research indicates that resistance training is generally safe for stroke survivors, with no significant increase in adverse events reported. It can improve physical function and may reduce the risk of recurrent strokes or cardiac events. ^{2 6 7 8 9}

Is Resistive Training a promising treatment for stroke recovery?

Yes, Resistive Training is a promising treatment for stroke recovery. It helps improve muscle strength, function, and independence in stroke survivors. ^{1 2 3 4 10}

How is resistance training with protein different from other stroke recovery treatments?

Resistance training combined with protein intake is unique because it focuses on building muscle strength and improving physical function, which can enhance independence in stroke recovery. Unlike some other treatments that may focus on medication or passive therapies, this approach actively engages the muscles to promote recovery. ^{1 2 3 4 10}

Research Team

Alice S. Ryan, PhD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Eligibility Criteria

This trial is for stroke survivors who've had a stroke over 3 months ago, finished all regular post-stroke therapy, can walk 10 meters unassisted, and have the cognitive ability to consent and participate. It's not for those doing regular exercise, heavy drinkers, with certain neurological/cardiac conditions or severe medical issues that could affect participation.

Inclusion Criteria

I have finished all my scheduled physical therapy sessions after my stroke.

I had a stroke more than 3 months ago.

I can walk 10 meters by myself.

Exclusion Criteria

You have a history of severe memory problems, difficulty understanding or speaking, or untreated major depression.

- You were hospitalized for a severe medical condition in the last 3 months. - You have a chronic pain condition that limits physical activity. - You have serious lung or kidney problems. - You have untreated high blood pressure or diabetes. - You are taking oral steroids. - You are currently pregnant.

You drink more than three servings of alcohol per day, like 3 shots of liquor, 3 glasses of wine, or 3 beers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo resistive training combined with either protein supplementation or placebo for 12 weeks

12 weeks

Regular visits for training sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Protein Supplementation
• Resistive Training

Trial Overview The study tests if adding protein supplements to resistive training helps muscle growth more than just training with a placebo in chronic stroke patients. Participants will be randomly assigned to receive either protein or placebo after their exercise sessions.

Participant Groups

Group I: Resistive Training + Protein Experimental Treatment 1 Intervention

Participants will drink 30 grams of whey protein after each resistance training session.

Group II: Resistive Training Placebo Group 1 Intervention

Participants will drink a placebo beverage after each resistance training session.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Baltimore VA Medical Center

Collaborator

Trials

33

Recruited

3,000+

Findings from Research

Resistance training has been shown to be beneficial for stroke patients, improving various recovery parameters such as muscular force, motor function, and health-related quality of life, based on a systematic review of 30 trials involving 1051 participants.

While resistance training is effective, it is not significantly better than other therapies for improving walking ability and balance, and it is less effective than ergometer training for cardiorespiratory fitness, indicating that the type of training protocol used is crucial for maximizing recovery benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training in stroke rehabilitation: systematic review and meta-analysis. Veldema, J., Jansen, P.[2022]

Lower limb resistance training (RT) significantly improved muscle strength in individuals with chronic stroke, particularly in knee extensors and flexors on the paretic side, with effect sizes indicating substantial gains despite very low to low evidence quality.

However, the training did not lead to improvements in mobility, gait, or quality of life, suggesting that while RT can enhance muscle strength, it may not translate to better functional outcomes in daily activities for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of lower limb resistance training on ICF components in chronic stroke: A systematic review and meta-analysis of RCTs. Pereira, TA., de Oliveira, MPB., Serrão, PRMDS., et al.[2023]

A 12-week supervised high-intensity progressive resistance training (PRT) program significantly improved lower extremity strength in stroke survivors, with increases in strength for both the affected and unaffected legs.

Participants in the PRT group reported better function and reduced disability, highlighting the potential of PRT to enhance recovery and quality of life for older stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity resistance training improves muscle strength, self-reported function, and disability in long-term stroke survivors. Ouellette, MM., LeBrasseur, NK., Bean, JF., et al.[2022]

A combined aerobic and resistance training program following American Stroke Association guidelines significantly improves mobility in stroke survivors, evidenced by increased walking speed and endurance in a meta-analysis of 499 participants.

The exercise program was found to be safe with high adherence rates and few reported adverse events, suggesting it can be effectively integrated into usual care for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Programs Delivered According to Guidelines Improve Mobility in People With Stroke: A Systematic Review and Meta-analysis. Pogrebnoy, D., Dennett, A.[2020]

In a study of 47 stroke survivors undergoing a 6-week training program, both robot-aided progressive resistance training and active-assisted robot-aided exercises led to improvements in upper limb motor control and strength, with no significant differences between the two methods.

The study found that individuals with better baseline motor control showed greater improvements in motor abilities, suggesting that initial capabilities may influence the effectiveness of robotic training interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two techniques of robot-aided upper limb exercise training after stroke. Stein, J., Krebs, HI., Frontera, WR., et al.[2019]

Progressive resistance training (PRT) is considered safe for individuals within the first 3 months after a stroke, as no significant increase in adverse events was reported in the studies reviewed.

However, the evidence suggests that PRT does not significantly improve muscle strength, upper limb function, or mobility during this early recovery period, indicating it may not be beneficial for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In the first 3 months after stroke is progressive resistance training safe and does it improve activity? A systematic review. Salter, K., Musovic, A., F Taylor, N.[2019]

Resistance Training is effective and safe for patients with coronary artery disease, as it enhances exercise tolerance, improves muscle strength, and reduces body fat, based on a review of 13 studies involving 1025 patients.

Tailored Resistance Training programs can significantly improve overall health-related quality of life and physical functioning in individuals with coronary artery disease, making it a vital component of their rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Resistance Training on Body Composition, Hemodynamic Parameters and Exercise Tolerance among Patients with Coronary Artery Disease: A Systematic Review. Sharma, A., Sharma, N., Vats, S., et al.[2023]

An 8-week dynamic resistance training program using elastic bands significantly improved physical function in stroke survivors, as evidenced by better performance in standing up from a sitting position and timed up and go tests.

The training also positively affected hemodynamic parameters and reduced oxidative stress markers, suggesting that this exercise regimen may lower the risk of recurrent strokes or cardiovascular events in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic Resistance Training Improves Cardiac Autonomic Modulation and Oxidative Stress Parameters in Chronic Stroke Survivors: A Randomized Controlled Trial. Gambassi, BB., Coelho-Junior, HJ., Paixão Dos Santos, C., et al.[2020]

Resistance training is a safe and effective method for improving muscle strength and aerobic endurance, particularly beneficial for healthy adults, the elderly, and patients with cardiac and pulmonary conditions.

Proper assessment and tailored exercise programs enhance the safety and long-term effectiveness of resistance training, contributing to better health outcomes and reduced risk factors for cardiovascular and metabolic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Resistance (strength) training in health promotion and rehabilitation]. Kostka, T.[2006]

In a study involving 18 stroke patients, machine training resulted in higher muscle activity in certain muscles compared to elastic resistance training during knee exercises, indicating that machines may be more effective for muscle engagement.

Elastic resistance training led to greater antagonist coactivation during knee flexion, suggesting it may be more challenging due to increased movement instability, even though both training methods had similar perceived exertion levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromyographic Comparison of Elastic Resistance and Machine Exercises for High-Intensity Strength Training in Patients With Chronic Stroke. Vinstrup, J., Calatayud, J., Jakobsen, MD., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Resistance training in stroke rehabilitation: systematic review and meta-analysis. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of lower limb resistance training on ICF components in chronic stroke: A systematic review and meta-analysis of RCTs. [2023]

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

High-intensity resistance training improves muscle strength, self-reported function, and disability in long-term stroke survivors. [2022]

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

Exercise Programs Delivered According to Guidelines Improve Mobility in People With Stroke: A Systematic Review and Meta-analysis. [2020]

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

Comparison of two techniques of robot-aided upper limb exercise training after stroke. [2019]

6. England pubmed.ncbi.nlm.nih.gov

In the first 3 months after stroke is progressive resistance training safe and does it improve activity? A systematic review. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Resistance Training on Body Composition, Hemodynamic Parameters and Exercise Tolerance among Patients with Coronary Artery Disease: A Systematic Review. [2023]

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

Dynamic Resistance Training Improves Cardiac Autonomic Modulation and Oxidative Stress Parameters in Chronic Stroke Survivors: A Randomized Controlled Trial. [2020]

9. Poland pubmed.ncbi.nlm.nih.gov

[Resistance (strength) training in health promotion and rehabilitation]. [2006]

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

Electromyographic Comparison of Elastic Resistance and Machine Exercises for High-Intensity Strength Training in Patients With Chronic Stroke. [2016]