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Completed

NCT Number: NCT01083901

Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance training

Behavioral

high intensity progressive resistance exercise training

Primary outcomes

  1. Change in Total Body Fat-free Mass

    Time frame: 16 weeks

    change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6)

Secondary outcomes

  1. Change in Total Body Fat Mass

    Time frame: 16 weeks

    Change from baseline to 16 weeks in total body fat mass.

  2. Changes in Upper Body Strength.

    Time frame: 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.

  3. Change in Lower Body Strength

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2010
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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