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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if drinking a protein shake after resistance training helps stroke survivors regain muscle strength more effectively than exercise alone. Many stroke survivors lose muscle over time, affecting their strength and overall health. Participants will drink either a protein shake or a placebo (a drink with no active ingredients) after workouts to identify the most effective approach. The trial seeks stroke survivors who have completed physical therapy and can walk 10 meters unassisted.

As an unphased trial, this study offers participants the chance to contribute to important research that could enhance recovery strategies for stroke survivors.

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.

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

Research has shown that resistance training, even when combined with protein supplements, is generally safe for people recovering from a stroke. Studies have found that participants usually handle this type of exercise well. Previous research reported no negative effects when participants used both resistance training and protein supplements. This suggests these methods are safe during stroke recovery. Prospective trial participants may find this information reassuring regarding the safety of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard stroke recovery treatments that often focus on medication or passive rehabilitation, this approach combines resistance training with whey protein supplementation. Researchers are excited about this method because it emphasizes muscle strengthening through active exercise, coupled with the nutritional boost from protein, which may enhance muscle recovery and growth. This dual approach could potentially accelerate recovery times and improve overall physical function more effectively than traditional methods alone. Moreover, incorporating whey protein as a dietary component is a novel angle that could offer additional benefits by supporting muscle repair and reducing muscle loss post-stroke.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

Research has shown that combining strength exercises with protein supplements can enhance muscle strength and function in stroke survivors. In this trial, one group will receive Resistive Training combined with Protein Supplementation, consuming 30 grams of whey protein after each resistance training session. One study found that exercise increased leg muscle strength by 113%, enabling faster walking and stronger stepping. Consuming protein post-exercise is believed to support muscle growth by providing essential nutrients. Other studies have also found that exercise with protein improves balance and facilitates daily activities. This combination holds promise for stroke recovery, aiding in regaining strength and independence. ^{1 2 6 7 8}

Who Is on the Research Team?

Alice S. Ryan, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02347995

Resistive Training Combined With Nutritional Therapy After ... The investigators propose to conduct a 12-week randomized placebo controlled clinical trial comparing the effects of RT+ protein supplementation at 1.2 g/kg/day ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9740942/

A Review of Rehabilitation Benefits of Exercise Training ... The results showed that the lower limb muscle strength, walking speed, and stepping strength of the resistance training group increased by 113%, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11813746/

Influence of nutritional status on rehabilitation efficacy ... Aerobic exercise training combined with protein supplementation significantly improves balance in stroke patients. Sakai K et al., 2019 (24) ...

4. withpower.com withpower.com/trial/phase-stroke-7-2015-f4faa

Resistance Training + Protein for Stroke Recovery (REPS ... Yes, Resistive Training is a promising treatment for stroke recovery. It helps improve muscle strength, function, and independence in stroke survivors.

5. mdpi.com mdpi.com/2072-6643/16/24/4264

Effects of Nutritional Support with a Leucine-Enriched ... The administration of a leucine-enriched essential amino acid supplement for 3 months significantly improved ADL performance and increased muscle mass and ...

6. trialx.com trialx.com/clinical-trials/listings/230503/resistive-training-combined-with-nutritional-therapy-after-stroke/

Resistive Training Combined With Nutritional Therapy After ... Protein supplementation can significantly augment gains in muscle mass after RT in healthy populations, but no experiments have yet been conducted in stroke.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9362889/

Effects of Creatine Supplementation and Progressive ... There were no adverse events reported in regards to PRT or supplementation. Creatine or placebo combined with PRT had no detrimental effect on any outcome ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03637270

Protein Supplementation for Chronic Stroke Treatment Participants in PRO group receive dietary supplementation with protein-rich supplements immediately before and after each exercise training session. The ...