Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training

Study Overview
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Brief Summary
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The purpose of this study is to determine if taking the pain reliever acetaminophen (ACET) interferes with some of the benefits of weight lifting on muscles and bone density in older men.

Detailed Description
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The commonly used pain relievers acetaminophen and ibuprofen may impair musculoskeletal adaptations to progressive resistance exercise training by inhibiting exercise-induced muscle protein synthesis. To test the hypothesis that acetaminophen and ibuprofen would diminish training-induced increases in fat-free mass, untrained men (n=26) aged ≥ 50 years participated in 16 weeks of high-intensity progressive resistance exercise training and bone-loading exercises and were randomly assigned to take ACET (1000 mg), ibuprofen (400 mg) or placebo 2 hours before each exercise session. The primary outcome was the change in total body fat-free mass measured by dual-energy X-ray absorptiometry (DXA) at baseline and week 16. Our primary interest was in the comparison of the acetaminophen and placebo groups.

Official Title
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Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training

Conditions
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Sarcopenia, Osteoporosis, Aging

Intervention / Treatment
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* Behavioral: Resistance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: average use of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) [including aspirin] less than 3 days per month not currently engaged in moderate-to-vigorous weight-lifting exercise non-smoker willing to participate in a supervised exercise program for 9 months Exclusion Criteria: relative or absolute contraindications to regular use of acetaminophen or NSAIDs including known allergy or intolerance to either drug,history of peptic ulcer or GI bleeding, anemia, asthma with bronchospasm induced by aspirin or other NSAIDS, moderate or severe renal impairment, known hepatobiliary disease contraindications to exercise testing and training including congestive heart failure class III or IV, uncontrolled hypertension and unstable cardiovascular disease thyroid dysfunction orthopedic problems that limit the ability to perform vigorous exercise or increase the likelihood of the use of pain medications drugs known to alter bone metabolism allergy to lidocaine diabetes mellitus requiring pharmacologic therapy

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance training with Acetaminophen<br>Acetaminophen | Behavioral: Resistance training<br>* high intensity progressive resistance exercise training<br>|
| Experimental: Resistance Training with ibuprofen<br>Ibuprofen | Behavioral: Resistance training<br>* high intensity progressive resistance exercise training<br>|
| Placebo Comparator: placebo<br>Placebo | Behavioral: Resistance training<br>* high intensity progressive resistance exercise training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Body Fat-free Mass | change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6) | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Body Fat Mass | Change from baseline to 16 weeks in total body fat mass. | 16 weeks | 
| Changes in Upper Body Strength. | Strength was measured using the one-repetition maximum method. Upper body strength was a composite of bench press, overhead press, seated row, and lateral pull-down strength. | 16 weeks | 
| Change in Lower Body Strength | Strength was measured using the one-repetition maximum method. Lower body strength was a composite of knee flexion, knee extension, and leg press strength. | 16 weeks |