SarcopeniaREPAiRSNCT01355861
Resistance Exercise for the Prevention of Age-related Sarcopenia
A study testing Negative work exercise in people with Sarcopenia, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 79 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Negative work exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 79 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, DC
Washington D.C., District of Columbia, 20422
About this study
Official title: Negative Work Exercise as a Novel Treatment for Sarcopenia in Older Men
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Negative work exercise
- Keywords
- sarcopenia, aging, rehabilitation, exercise
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative work exerciseBehavioural
Also called Biodex
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Exercise group 1: Negative work exercise Receives: Behavioral: Negative work exercise |
| 2 | Other | Exercise group 2: Negative work exercise (delayed start for single-arm crossover trial) Receives: Behavioral: Negative work exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline in QUICKI values at week 6, week 12, and week 24
Secondary outcomes (2)
Peak isokinetic torque
Isokinetic knee and shoulder extension torques will be obtained bilaterally using the Biodex System 3
Measured: Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
Diagnostic ultrasongraphy
Muscle thickness, pennation angle, and area at the flexor digitorum superficialis, lower-trapezius, rectus femoris and tibialis anterior (dominant side only).
Measured: Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Why it stopped: Project has been withdrawn from funding consideration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Michael Harris-Love, DSc MPT BS, Principal investigator, VA Medical Center, DC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355861
- Sponsor's protocol ID
- E7508-W
- Acronym
- REPAiRS
- Status last verified
- Jun 2015
- First submitted
- 14 Mar 2011
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Work Exercise as a Novel Treatment for Sarcopenia in Older Men
- ClinicalTrials.gov ID
- NCT01355861
- Acronym / sponsor ID
- REPAiRS / E7508-W
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, aging, rehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project has been withdrawn from funding consideration
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2011
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Negative work exerciseExercise group 1: Negative work exercise |
| 2 | Other | Behavioral: Negative work exerciseExercise group 2: Negative work exercise (delayed start for single-arm crossover trial) |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative work exerciseAlso: BiodexSubmaximal 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. | Behavioural | 1, 2 |
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.
2 secondary outcomes
Peak isokinetic torque
Time frame: Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
Diagnostic ultrasongraphy
Time frame: Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Harris-Love, DSc MPT BS principal investigator
VA Medical Center, DC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative work exercise in people with Sarcopenia, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.