Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training

Not Applicable

Completed

• Conditions: Sarcopenia; Osteoporosis; Aging
• Interventions: Behavioral: Resistance training

• Registration Number: NCT01083901
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2013-02-04
• Results First Submitted QC: 2013-02-04
• Results First Posted: 2013-03-08
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistance training with Acetaminophen	Resistance training	Acetaminophen
Resistance Training with ibuprofen	Resistance training	Ibuprofen
placebo	Resistance training	Placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Total Body Fat Mass	16 weeks	Change from baseline to 16 weeks in total body fat mass.
Changes in Upper Body Strength.	16 weeks	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.
Change in Lower Body Strength	16 weeks	Strength was measured using the one-repetition maximum method. Lower body strength was a composite of knee flexion, knee extension, and leg press strength.

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States