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Withdrawn
(Project has been withdrawn from funding consideration)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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcopenia | Behavioral: Negative work exercise | Not Applicable |
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 |

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
|
- 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.
- 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).

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Ages Eligible for Study: | 60 Years to 79 Years (Adult, Senior) |
Sexes 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.

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
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 |
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 |