Resistance Exercise for the Prevention of Age-related Sarcopenia (REPAiRS)
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Purpose
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 | Intervention |
|---|---|
|
Sarcopenia |
Behavioral: Negative work exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Negative Work Exercise as a Novel Treatment for Sarcopenia in Older Men |
- 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 ] [ Designated as safety issue: No ]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.
- Peak isokinetic torque [ Time Frame: Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Muscle thickness, pennation angle, and area at the flexor digitorum superficialis, lower-trapezius, rectus femoris and tibialis anterior (dominant side only).
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 60 Years to 79 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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| United States, District of Columbia | |
| VA Medical Center, DC | |
| Washington, District of Columbia, United States, 20422 | |
| Principal Investigator: | Michael Harris-Love, DSc MPT BS | VA Medical Center, DC |
More Information
No publications provided
| Responsible Party: | Harris-Love, Michael - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01355861 History of Changes |
| Other Study ID Numbers: | E7508W, E7508W |
| Study First Received: | March 14, 2011 |
| Last Updated: | May 16, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
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 |
ClinicalTrials.gov processed this record on June 17, 2013