Clinical trial NCT01355861: Resistance Exercise for the Prevention of Age-related Sarcopenia
Official title: Negative Work Exercise as a Novel Treatment for Sarcopenia in Older Men
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sarcopenia
Keywords: sarcopenia
aging
rehabilitation
exercise
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-05-18
Enrollment: 0
Sex: MALE
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in insulin sensitivity following the exercise intervention as estimated with the QUICKI algorithm (quantitative insulin sensitivity check index)
timeFrame: Change from baseline in QUICKI values at week 6, week 12, and week 24
Secondary outcomes:
measure: Peak isokinetic torque
timeFrame: Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
measure: Diagnostic ultrasongraphy
timeFrame: Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
Other outcomes:
Locations:
city: Washington
country: United States
facility: VA Medical Center, DC
state: District of Columbia
Study officials:
affiliation: VA Medical Center, DC
name: Michael Harris-Love, DSc MPT BS
role: PRINCIPAL_INVESTIGATOR
References: