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.
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.
12345What 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.
26789Eligibility 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.
+1 more
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.
+3 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Resistive Training + ProteinExperimental Treatment1 Intervention
Participants will drink 30 grams of whey protein after each resistance training session.
Group II: Resistive TrainingPlacebo Group1 Intervention
Participants will drink a placebo beverage after each resistance training session.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimore, MD
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
Baltimore VA Medical CenterCollaborator
References
Resistance training in stroke rehabilitation: systematic review and meta-analysis. [2022]This systematic review and meta-analysis investigates the effects of resistance training in supporting the recovery in stroke patients.
Effect of lower limb resistance training on ICF components in chronic stroke: A systematic review and meta-analysis of RCTs. [2023]Resistance training (RT) effectively promotes functional independence after stroke.
High-intensity resistance training improves muscle strength, self-reported function, and disability in long-term stroke survivors. [2022]To evaluate the efficacy of supervised high-intensity progressive resistance training (PRT) on lower extremity strength, function, and disability in older, long-term stroke survivors.
Exercise Programs Delivered According to Guidelines Improve Mobility in People With Stroke: A Systematic Review and Meta-analysis. [2020]To determine if prescribing a combined aerobic and resistance training exercise program in accordance with American Stroke Association physical activity guidelines improves mobility and physical activity levels of people after stroke.
Comparison of two techniques of robot-aided upper limb exercise training after stroke. [2019]This study examined whether incorporating progressive resistive training into robot-aided exercise training provides incremental benefits over active-assisted robot-aided exercise for the upper limb after stroke.
In the first 3 months after stroke is progressive resistance training safe and does it improve activity? A systematic review. [2019]BACKGROUND Progressive resistance training (PRT) can improve strength and function in people with chronic stroke, but less is known about whether this intervention is safe and beneficial during the first 3 months following stroke. OBJECTIVE To systematically review the evidence about the safety and effectiveness of PRT to improve activity in people within the first 3 months after stroke. METHODS After database searching and selection of studies a risk of bias assessment was conducted. Data for the primary outcome of safety was synthesised descriptively and meta-analyses for other outcomes were conducted using a random effects model. RESULTS The quality of the 5 included studies ranged from good to excellent (mean 24.2, range 20-28). For the trials investigating adverse events, none reported any significant increase in events after PRT. There was high level evidence that PRT had little or no effect on strength (SMD (standardized mean difference) 0.17, 95% CI -0.16 to 0.50, I(2) = 0%). There were no significant benefit for upper limb function (SMD 0.11, 95% CI -0.41 to 0.63, I(2) = 0%) and mobility (SMD 0.11, 95% CI -0.21 to 0.43, I(2) = 27%) after PRT compared with controls. CONCLUSIONS There was no evidence reported that PRT is unsafe in people within the first 3 months after stroke, although there was a lack of reporting about adverse events. The lack of demonstration of effect in improving muscle strength and activity suggests there is insufficient evidence to recommend the prescription of PRT for people within the first 3 months after stroke.
Effect of Resistance Training on Body Composition, Hemodynamic Parameters and Exercise Tolerance among Patients with Coronary Artery Disease: A Systematic Review. [2023]Effectiveness and safety of Resistance Training in treating various Cerebrovascular Disease diagnoses have drawn attention in recent years. Patients suffering with coronary artery disease should be offered individually tailored Resistance Training in their exercise regimen. Resistance Training was developed to help individuals with their functional status, mobility, physical performance, and muscle strength.
Dynamic Resistance Training Improves Cardiac Autonomic Modulation and Oxidative Stress Parameters in Chronic Stroke Survivors: A Randomized Controlled Trial. [2020]Stroke survivors are at substantial risk of recurrent cerebrovascular event or cardiovascular disease. Exercise training offers nonpharmacological treatment for these subjects; however, the execution of the traditional exercise protocols and adherence is constantly pointed out as obstacles. Based on these premises, the present study investigated the impact of an 8-week dynamic resistance training protocol with elastic bands on functional, hemodynamic, and cardiac autonomic modulation, oxidative stress markers, and plasma nitrite concentration in stroke survivors. Twenty-two patients with stroke were randomized into control group (CG, n = 11) or training group (TG, n = 11). Cardiac autonomic modulation, oxidative stress markers, plasma nitrite concentration, physical function and hemodynamic parameters were evaluated before and after 8 weeks. Results indicated that functional parameters (standing up from the sitting position (P = 0.011) and timed up and go (P = 0.042)) were significantly improved in TG. Although not statistically different, both systolic blood pressure (Δ = -10.41 mmHg) and diastolic blood pressure (Δ = -8.16 mmHg) were reduced in TG when compared to CG. Additionally, cardiac autonomic modulation (sympathovagal balance-LF/HF ratio) and superoxide dismutase were improved, while thiobarbituric acid reactive substances and carbonyl levels were reduced in TG when compared to the CG subjects. In conclusion, our findings support the hypothesis that dynamic resistance training with elastic bands may improve physical function, hemodynamic parameters, autonomic modulation, and oxidative stress markers in stroke survivors. These positive changes would be associated with a reduced risk of a recurrent stroke or cardiac event in these subjects.
[Resistance (strength) training in health promotion and rehabilitation]. [2006]Recent research data bring about sound scientific evidence on the importance of resistance training in health promotion and primary and secondary prevention of many diseases. This paper reviews the current scientific evidence and the most important recommendations on resistive training programming in healthy adults, elderly subjects and cardiac and pulmonary patients. An adequate resistance training appears to be an effective and safe method of improvement of muscle strength, enhancement of aerobic endurance (VO2max), beneficial modification of risk factors of cardiovascular and metabolic diseases, and increase in autonomy and well-being, especially in the elderly and cardiac and pulmonary patients. An appropriate preliminary examination, exercise programme and medical control increase the safety and long-term effectiveness of strength training.
Electromyographic Comparison of Elastic Resistance and Machine Exercises for High-Intensity Strength Training in Patients With Chronic Stroke. [2016]To investigate whether elastic resistance training can induce comparable levels of muscle activity as conventional machine training in patients with chronic stroke.