Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sarcopenia Osteoporosis Aging |
Behavioral: high intensity progressive resistance exercise training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) |
| Official Title: | Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training |
- Change in Total Body Fat-free Mass [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6)
- Change in Total Body Fat Mass [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Change from baseline to 16 weeks in total body fat mass.
- Changes in Upper Body Strength. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Strength was measured using the one-repetition maximum method. Lower body strength was a composite of knee flexion, knee extension, and leg press strength.
| Enrollment: | 34 |
| Study Start Date: | May 2006 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Acetaminophen
Acetaminophen
|
Behavioral: high intensity progressive resistance exercise training |
|
Experimental: ibuprofen
Ibuprofen
|
Behavioral: high intensity progressive resistance exercise training |
|
Placebo Comparator: placebo
Placebo
|
Behavioral: high intensity progressive resistance exercise training |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01083901 History of Changes |
| Other Study ID Numbers: | 06-0343, R21AG027809 |
| Study First Received: | March 8, 2010 |
| Results First Received: | February 4, 2013 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Osteoporosis Sarcopenia Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Atrophy Pathological Conditions, Anatomical |
Signs and Symptoms Acetaminophen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013