Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training

Aging Clinical Trial

Official title:

Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083901
• Other study ID #: 06-0343
• Secondary ID: R21AG027809
• Status: Completed
• Phase: N/A
• First received: March 8, 2010
• Last updated: June 17, 2013
• Start date: May 2006
• Est. completion date: March 2011

Study information

• Verified date: June 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Aging
• Osteoporosis
• Sarcopenia

Intervention

Behavioral:
• Resistance training
high intensity progressive resistance exercise training

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Total Body Fat Mass	Change from baseline to 16 weeks in total body fat mass.	16 weeks	No
Secondary	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	No
Secondary	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	No