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Resistive Training Combined With Nutritional Therapy After Stroke (REPS)

This study is currently recruiting participants.
Verified November 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT02347995
First Posted: January 28, 2015
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Baltimore VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development
January 8, 2015
January 28, 2015
November 9, 2017
August 24, 2015
June 1, 2020   (Final data collection date for primary outcome measure)
Change in thigh muscle area [ Time Frame: Measured at baseline and after the 3 month intervention ]
muscle area in cm2
Change in thigh muscle area [ Time Frame: Measured at baseline and after the 3 month intervention ]
Complete list of historical versions of study NCT02347995 on ClinicalTrials.gov Archive Site
  • Change in muscle quality (strength per unit muscle volume) [ Time Frame: Measured at baseline and after the 3 month intervention ]
    strength per unit muscle volume
  • Change in functional mobility (6 min walk distance) [ Time Frame: Measured at baseline and after the 3 month intervention ]
    6 min walk distance
  • Change in myostatin messenger RNA (mRNA) level [ Time Frame: Measured at baseline and after the 3 month intervention ]
    myostatin mRNA (AU)
  • Change in muscle quality (strength per unit muscle volume) [ Time Frame: Measured at baseline and after the 3 month intervention ]
    strength per unit muscle volume
  • Change in functional mobility (6 min walk distance) [ Time Frame: Measured at baseline and after the 3 month intervention ]
    6 min walk distance
  • Change in myostatin mRNA level [ Time Frame: Measured at baseline and after the 3 month intervention ]
Not Provided
Not Provided
 
Resistive Training Combined With Nutritional Therapy After Stroke
Resistive Training Combined With Nutritional Therapy After Stroke
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Stroke
  • Other: Protein
    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.
  • Other: Placebo
    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.
  • Placebo Comparator: Resistive Training
    Participants will drink a placebo beverage after each resistance training session.
    Intervention: Other: Placebo
  • Experimental: Resistive Training + Protein
    Participants will drink 30 grams of whey protein after each resistance training session.
    Intervention: Other: Protein
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 1, 2020
June 1, 2020   (Final data collection date for primary outcome measure)

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) peripheral arterial disease with vascular claudication, c) orthopedic or chronic pain condition restricting exercise, d) pulmonary or renal failure, e) active cancer, f) untreated poorly controlled hypertension measured on at least 2 occasions (greater than 190/100) g) untreated and / or poorly controlled diabetes with fasting blood glucose of greater than 170 and HbA1c greater than 10.0, h) medications: heparin, warfarin, lovenox, apixaban, dabigatran, rivaroxaban, and oral steroids, i) 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
Sexes Eligible for Study: All
30 Years to 85 Years   (Adult, Senior)
No
Contact: Alice S Ryan, PhD (410) 605-7851 Alice.Ryan@va.gov
Contact: Frederick M Ivey, PhD (410) 375-8419 Frederick.Ivey@va.gov
United States
 
 
NCT02347995
N1461-R
HP-00062067 ( Other Identifier: Baltimore VAMC )
Yes
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
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Baltimore VA Medical Center
Principal Investigator: Alice S Ryan, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
VA Office of Research and Development
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP