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Resistance Exercise for the Prevention of Age-related Sarcopenia (REPAiRS)

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ClinicalTrials.gov Identifier: NCT01355861
Recruitment Status : Withdrawn (Project has been withdrawn from funding consideration)
First Posted : May 18, 2011
Last Update Posted : June 26, 2015
Sponsor:
Information provided by:
VA Office of Research and Development

Study Description
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Brief Summary:
The purpose of this study is to determine the benefits of negative work progressive resistance exercise (PRE) for the conservative management of sarcopenia in older male Veterans at the DC VAMC. Efficacy will be assessed by examining post-exercise changes in metabolic and inflammatory markers, muscle morphology, strength, and functional status.

Condition or disease Intervention/treatment Phase
Sarcopenia Behavioral: Negative work exercise Not Applicable

Detailed Description:
The chief aim of this protocol is to determine the efficacy of negative work progressive resistance exercise (PRE) in the management of sarcopenia in older male Veterans at the DC VAMC. This proposed study is a randomized clinical trial using a single-arm, delayed cross-over design with repeated measures. This method is a patient-first approach to clinical research that permits all participants to receive the intervention while allowing the investigators to conduct both within subjects and between subjects comparisons with a modest study enrollment. During the "pre-treatment period" we will recruit, screen, and consent 30 older men with sarcopenia. The participants will be randomized into two groups: active treatment and delayed treatment. The initial "active treatment" and "delayed treatment" periods will last 12 weeks. After 12 weeks, the participants in the delayed treatment group will crossover (without a washout period) and start 12 weeks of intervention. All participants will detrain and be monitored for follow up during their respective 12-week "post treatment" period. Outcome measures include post-exercise changes in metabolic and inflammatory markers, muscle morphology, strength, and functional status.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Negative Work Exercise as a Novel Treatment for Sarcopenia in Older Men
Study Start Date : June 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Exercise group 1: Negative work exercise
 Behavioral: Negative work exercise
Submaximal negative work exercise using an isokinetic dynamometer will be performed twice per week for 12 weeks. Exercise volume will be 3 sets of 10 repetitions for the knee and shoulder extensors.
Other Name: Biodex
2
Exercise group 2: Negative work exercise (delayed start for single-arm crossover trial)
 Behavioral: Negative work exercise
Submaximal negative work exercise using an isokinetic dynamometer will be performed twice per week for 12 weeks. Exercise volume will be 3 sets of 10 repetitions for the knee and shoulder extensors.
Other Name: Biodex


Outcome Measures
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Primary Outcome Measures :
  1. Changes in insulin sensitivity following the exercise intervention as estimated with the QUICKI algorithm (quantitative insulin sensitivity check index) [ Time Frame: Change from baseline in QUICKI values at week 6, week 12, and week 24 ]
    Blood tests will be obtained after a 12- hour overnight fast at baseline, weeks 6, week 12 and week 24: glucose and insulin values will be determined before and during a standard (75 g) 2 hour oral glucose tolerance test (to determine insulin sensitivity via QUICKI algorithm.


Secondary Outcome Measures :
  1. Peak isokinetic torque [ Time Frame: Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12 ]
    Isokinetic knee and shoulder extension torques will be obtained bilaterally using the Biodex System 3

  2. Diagnostic ultrasongraphy [ Time Frame: Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12 ]
    Muscle thickness, pennation angle, and area at the flexor digitorum superficialis, lower-trapezius, rectus femoris and tibialis anterior (dominant side only).


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Adult, ambulatory males > 60 years old (n=30) will be recruited for this proposed study. Participant inclusion criteria also includes having clinically significant sarcopenia based on the body composition assessment showing an aLM that is < 2 SD below the mean values of a young adult reference group using DEXA scanning.

Exclusion Criteria:

Exclusion criteria include BMI scores > 30 or a Mini-Mental Status exam score of < 22. The second tier of screening will include the following blood tests, obtained between 8-9 AM, following a 12-hour overnight fast: CBC, routine chemistry profile (e.g., glucose, kidney and liver function tests). Veterans with an elevated fasting blood glucose by WHO criteria (FBG >110 mg/dl), triglyceride levels > 200 mg/dL, and/or known DM, or abnormalities of other routine blood tests (i.e., > 2 SD beyond normal) will be excluded from the study. Uncontrolled cardiovascular disease, non-ambulatory status, evidence of a major disease exacerbation over the last six months, and current participation in a supervised exercise program (minimum of three months, twice per week) would also preclude participation in this study.

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355861


Locations
United States, District of Columbia
VA Medical Center, DC
Washington, District of Columbia, United States, 20422
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Michael Harris-Love, DSc MPT BS VA Medical Center, DC
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Harris-Love, Michael - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01355861     History of Changes
Other Study ID Numbers: E7508-W
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by VA Office of Research and Development:
sarcopenia
aging
rehabilitation
exercise

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
 Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms