Expired Study
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Washington, District of Columbia 20422


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.


Study 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.


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.


Study is Available At:


Original ID:

E7508-W


NCT ID:

NCT01355861


Secondary ID:


Study Acronym:

REPAiRS


Brief Title:

Resistance Exercise for the Prevention of Age-related Sarcopenia


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Male


Minimum Age:

60 Years


Maximum Age:

79 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:

Project has been withdrawn from funding cons


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael Harris-Love, DSc MPT BS
Principal Investigator
VA Medical Center, DC

Study Dates

Start Date:June 2011
Completion Date:June 2014
Completion Type:Anticipated
Primary Completion Date:June 2014
Primary Completion Type:Anticipated
Verification Date:June 2015
Last Changed Date:June 25, 2015
First Received Date:March 14, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Peak isokinetic torque
Time Frame:Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
Safety Issues:False
Description:Isokinetic knee and shoulder extension torques will be obtained bilaterally using the Biodex System 3
Outcome Type:Secondary Outcome
Measure:Diagnostic ultrasongraphy
Time Frame:Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
Safety Issues:False
Description:Muscle thickness, pennation angle, and area at the flexor digitorum superficialis, lower-trapezius, rectus femoris and tibialis anterior (dominant side only).

Study Interventions

Intervention Type:Behavioral
Name:Negative work exercise
Description: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.
Arm Name:1
Other Name:Biodex

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Exercise group 1: Negative work exercise
Study Arm Type:Other
Arm Name:2
Description:Exercise group 2: Negative work exercise (delayed start for single-arm crossover trial)

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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