Back to resultsResistance Exercise for the Prevention of Age-related Sarcopenia (REPAiRS)
Primary Purpose
Sarcopenia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative work exercise
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia focused on measuring sarcopenia, aging, rehabilitation, exercise
Eligibility 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.
Sites / Locations
- VA Medical Center, DC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
Exercise group 1: Negative work exercise
Exercise group 2: Negative work exercise (delayed start for single-arm crossover trial)
Outcomes
Primary Outcome Measures
Changes in insulin sensitivity following the exercise intervention as estimated with the QUICKI algorithm (quantitative insulin sensitivity check index)
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
Peak isokinetic torque
Isokinetic knee and shoulder extension torques will be obtained bilaterally using the Biodex System 3
Diagnostic ultrasongraphy
Muscle thickness, pennation angle, and area at the flexor digitorum superficialis, lower-trapezius, rectus femoris and tibialis anterior (dominant side only).
Full Information
NCT ID
NCT01355861
First Posted
March 14, 2011
Last Updated
June 25, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT01355861
Brief Title
Resistance Exercise for the Prevention of Age-related Sarcopenia
Acronym
REPAiRS
Official Title
Negative Work Exercise as a Novel Treatment for Sarcopenia in Older Men
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Project has been withdrawn from funding consideration
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
sarcopenia, aging, rehabilitation, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Exercise group 1: Negative work exercise
Arm Title
2
Arm Type
Other
Arm Description
Exercise group 2: Negative work exercise (delayed start for single-arm crossover trial)
Intervention Type
Behavioral
Intervention Name(s)
Negative work exercise
Other Intervention Name(s)
Biodex
Intervention 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.
Primary Outcome Measure Information:
Title
Changes in insulin sensitivity following the exercise intervention as estimated with the QUICKI algorithm (quantitative insulin sensitivity check index)
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 via QUICKI algorithm.
Time Frame
Change from baseline in QUICKI values at week 6, week 12, and week 24
Secondary Outcome Measure Information:
Title
Peak isokinetic torque
Description
Isokinetic knee and shoulder extension torques will be obtained bilaterally using the Biodex System 3
Time Frame
Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
Title
Diagnostic ultrasongraphy
Description
Muscle thickness, pennation angle, and area at the flexor digitorum superficialis, lower-trapezius, rectus femoris and tibialis anterior (dominant side only).
Time Frame
Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Harris-Love, DSc MPT BS
Organizational Affiliation
VA Medical Center, DC
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Resistance Exercise for the Prevention of Age-related Sarcopenia
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