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Resistance Training + Protein for Stroke Recovery (REPS Trial)
N/A
Recruiting
Led By Alice S. Ryan, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Completion of all regular post-stroke physical therapy
Able to walk 10 meters without human assistance
Must not have
Cardiac history of: a) unstable angina, b) recent (less than 3 months prior to study entry) myocardial infarction, congestive heart failure (NYHA category II-IV); c) hemodynamically significant valvular dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline and after the 3 month intervention
Summary
This trial will compare the effects of resistive training with or without protein supplementation in people who have suffered a stroke.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include digestive discomfort from the protein supplement and typical risks associated with resistance training such as muscle soreness or strain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have finished all my scheduled physical therapy sessions after my stroke.
Select...
I can walk 10 meters by myself.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a recent history of serious heart issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline and after the 3 month intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline and after the 3 month intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in thigh muscle area
Secondary study objectives
Change in functional mobility (6 min walk distance)
Change in muscle strength
Change in myostatin messenger RNA (mRNA) level
Trial Design
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 Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,633 Total Patients Enrolled
86 Trials studying Stroke
6,733 Patients Enrolled for Stroke
Baltimore VA Medical CenterFED
32 Previous Clinical Trials
2,945 Total Patients Enrolled
5 Trials studying Stroke
702 Patients Enrolled for Stroke
Alice S. Ryan, PhDPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
6 Previous Clinical Trials
581 Total Patients Enrolled
1 Trials studying Stroke
98 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have finished all my scheduled physical therapy sessions after my stroke.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.I had a stroke more than 3 months ago.I can walk 10 meters by myself.You drink more than three servings of alcohol per day, like 3 shots of liquor, 3 glasses of wine, or 3 beers.You do resistance exercise regularly, at least twice a week.I can understand and communicate well enough to participate in tests and give informed consent.I have a recent history of serious heart issues.
Research Study Groups:
This trial has the following groups:- Group 1: Resistive Training + Protein
- Group 2: Resistive Training
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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