Clinical Trial: Resistance Exercise for the Prevention of Age-related Sarcopenia

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Negative Work Exercise as a Novel Treatment for Sarcopenia in Older Men

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.

Detailed Summary: 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.
Sponsor: VA Office of Research and Development

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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).


Original Secondary Outcome: Same as current

Information By: VA Office of Research and Development

Dates:
Date Received: March 14, 2011
Date Started: June 2011
Date Completion: June 2014
Last Updated: June 25, 2015
Last Verified: June 2015