Resistive Training Combined With Nutritional Therapy After Stroke (REPS)
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Exercise, Protein, Nutrition, Stroke
Eligibility Criteria
Inclusion Criteria:
- Stroke > 3 months prior
- Completion of all regular post-stroke physical therapy
- Adequate language and neurocognitive function to participate in testing and training and to provide informed consent
- Able to walk 10 meters without human assistance
Exclusion Criteria:
- Regular structured resistive exercise (>2x/week)
- Alcohol consumption >3oz. liquor, 3 x 4oz. glasses of wine, or 3 x 12oz beers/day, by self report
- Neurological history of: a) dementia by clinical evaluation, b) severe receptive or global aphasia, which confounds testing and training, operationally defined as unable to follow 2 point commands, c) untreated major depression by clinical interview
- Medical History: a) recent hospitalization (less than 3 months prior to study entry) for severe medical disease, b) orthopedic or chronic pain condition restricting exercise, c) pulmonary or renal failure, d) active cancer, e) untreated poorly controlled hypertension measured on at least 2 occasions (greater than 190/100) f) untreated and / or poorly controlled diabetes with fasting blood glucose of greater than 170 and HbA1c greater than 10.0, g) medications: oral steroids, h) currently pregnant
- 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
- Any medical condition that, in the opinion of the Investigator, might interfere with the subject's participation in the study, poses any added risk for the subject, or confounds the assessment of the subject
Sites / Locations
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Resistive Training
Resistive Training + Protein
Arm Description
Participants will drink a placebo beverage after each resistance training session.
Participants will drink 30 grams of whey protein after each resistance training session.
Outcomes
Primary Outcome Measures
Change in thigh muscle area
muscle area in cm2
Secondary Outcome Measures
Change in muscle strength
strength
Change in functional mobility (6 min walk distance)
6 min walk distance
Change in myostatin messenger RNA (mRNA) level
myostatin mRNA (AU)
Full Information
NCT ID
NCT02347995
First Posted
January 8, 2015
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
Collaborators
Baltimore VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02347995
Brief Title
Resistive Training Combined With Nutritional Therapy After Stroke
Acronym
REPS
Official Title
Resistive Training Combined With Nutritional Therapy After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2015 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Baltimore VA Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
The VA research team has played a prominent role in documenting the significant skeletal muscle atrophy that accompanies chronic hemiparesis after disabling stroke. Muscle volume is reduced by 24% in paretic vs. non-paretic legs, having significant implications for strength, function, fitness, metabolism and general health. The investigators' previous work establishes progressive, high-intensity resistive training (RT) as an effective rehabilitation strategy for older stroke survivors, producing thigh muscle hypertrophy on both the paretic and non-paretic sides. Protein supplementation can significantly augment gains in muscle mass after RT in healthy populations, but no experiments have yet been conducted in stroke. New preliminary data from the investigators' group indicates that stroke participants consume 20% less protein than the recommended daily amount for older individuals (0.80 vs. 1.0 g/kg/day) suggesting that relative gains in skeletal muscle could be significantly better in the presence of adequate protein intake. New data also indicates that leg muscle mass predicts resting metabolic rate (RMR) in stroke, implying that a combined nutrition and RT therapy aimed at maximizing muscle gains would translate into improved energy balance, a key factor in rehabilitation success. A better understanding of the true potential for aggressive RT interventions to address stroke-related atrophy and related problems for maximum benefit awaits clinical trials directly comparing RT with and without nutritional therapy. 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 (RT+PRO) vs. RT+isocaloric placebo (RT+PLA) on body composition, hypertrophy, strength, functional mobility and energy expenditure in chronic stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Exercise, Protein, Nutrition, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resistive Training
Arm Type
Placebo Comparator
Arm Description
Participants will drink a placebo beverage after each resistance training session.
Arm Title
Resistive Training + Protein
Arm Type
Experimental
Arm Description
Participants will drink 30 grams of whey protein after each resistance training session.
Intervention Type
Other
Intervention Name(s)
Protein
Intervention Description
This training is designed to target the major muscle groups of the leg. Resistance training will be completed through a combination of lower extremity machines and complemented by whole body exercises such as squatting. The lower extremity machines include leg press, leg extension, and leg curl. This group will drink a beverage containing protein after each training session.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
This training is designed to target the major muscle groups of the leg. Resistance training will be completed through a combination of lower extremity machines and complemented by whole body exercises such as squatting. The lower extremity machines include leg press, leg extension, and leg curl.This group will drink a placebo beverage after each training session.
Primary Outcome Measure Information:
Title
Change in thigh muscle area
Description
muscle area in cm2
Time Frame
Measured at baseline and after the 3 month intervention
Secondary Outcome Measure Information:
Title
Change in muscle strength
Description
strength
Time Frame
Measured at baseline and after the 3 month intervention
Title
Change in functional mobility (6 min walk distance)
Description
6 min walk distance
Time Frame
Measured at baseline and after the 3 month intervention
Title
Change in myostatin messenger RNA (mRNA) level
Description
myostatin mRNA (AU)
Time Frame
Measured at baseline and after the 3 month intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stroke > 3 months prior
Completion of all regular post-stroke physical therapy
Adequate language and neurocognitive function to participate in testing and training and to provide informed consent
Able to walk 10 meters without human assistance
Exclusion Criteria:
Regular structured resistive exercise (>2x/week)
Alcohol consumption >3oz. liquor, 3 x 4oz. glasses of wine, or 3 x 12oz beers/day, by self report
Neurological history of: a) dementia by clinical evaluation, b) severe receptive or global aphasia, which confounds testing and training, operationally defined as unable to follow 2 point commands, c) untreated major depression by clinical interview
Medical History: a) recent hospitalization (less than 3 months prior to study entry) for severe medical disease, b) orthopedic or chronic pain condition restricting exercise, c) pulmonary or renal failure, d) active cancer, e) untreated poorly controlled hypertension measured on at least 2 occasions (greater than 190/100) f) untreated and / or poorly controlled diabetes with fasting blood glucose of greater than 170 and HbA1c greater than 10.0, g) medications: oral steroids, h) currently pregnant
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
Any medical condition that, in the opinion of the Investigator, might interfere with the subject's participation in the study, poses any added risk for the subject, or confounds the assessment of the subject
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lynda C Robey
Phone
(410) 605-7000
Ext
5446
Email
lynda.robey@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice S. Ryan, PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynda C Robey
Phone
410-605-7000
Ext
5446
Email
lynda.robey@va.gov
First Name & Middle Initial & Last Name & Degree
Alice S. Ryan, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35192798
Citation
Ryan AS, Novitskaya M, Treuth AL. Predictive Equations Overestimate Resting Metabolic Rate in Survivors of Chronic Stroke. Arch Phys Med Rehabil. 2022 Jul;103(7):1352-1359. doi: 10.1016/j.apmr.2022.01.155. Epub 2022 Feb 19.
Results Reference
derived
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Resistive Training Combined With Nutritional Therapy After Stroke
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