Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training

NCT ID: NCT01083901

Last Updated: 2013-06-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-03-31

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.

Conditions

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Sarcopenia Osteoporosis Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Resistance training with Acetaminophen

Acetaminophen

Group Type EXPERIMENTAL

Resistance training

Intervention Type BEHAVIORAL

high intensity progressive resistance exercise training

Resistance Training with ibuprofen

Ibuprofen

Group Type EXPERIMENTAL

Resistance training

Intervention Type BEHAVIORAL

high intensity progressive resistance exercise training

placebo

Placebo

Group Type PLACEBO_COMPARATOR

Resistance training

Intervention Type BEHAVIORAL

high intensity progressive resistance exercise training

Interventions

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Resistance training

high intensity progressive resistance exercise training

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Jankowski, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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R21AG027809

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06-0343

Identifier Type: -

Identifier Source: org_study_id

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