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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG027809 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance training with Acetaminophen | Experimental | Acetaminophen |
|
| Resistance Training with ibuprofen | Experimental | Ibuprofen |
|
| placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance training | Behavioral | high intensity progressive resistance exercise training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Body Fat Mass | Change from baseline to 16 weeks in total body fat mass. | 16 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Jankowski, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
Volunteers who did not meet inclusion criteria were excluded from the study during the initial screening visits prior to randomization to the study arms.
Participants were enrolled from Dec 2006 to Jan 2010. They were recruited from the greater Denver area using advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen and Resistance Exercise | Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks. |
| FG001 | Ibuprofen and Resistance Exercise | Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks. |
| FG002 | Placebo and Resistance Exercise | Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen and Resistance Exercise | Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks. |
| BG001 | Ibuprofen and Resistance Exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | All participants with baseline and 16 week data were included in the analysis (i.e., intention-to-treat). | Posted | Mean | Standard Error | kg | 16 weeks |
|
Throughout the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetaminophen and Resistance Exercise Training |
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This was a preliminary study that was limited by small sample size, exclusion of women, and the duration of intervention which was too brief to measure changes in bone mineral density.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine M. Jankowski | University of Colorado Denver | 303-724-7383 | catherine.jankowski@ucdenver.edu |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| 16 weeks |
| 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 |
Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks. |
| BG002 | Placebo and Resistance Exercise | Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Fat-free mass | Total body fat-free mass measured by DXA (Hologic Discovery W, version 12.6) | Mean | Standard Deviation | kg |
|
| Fat mass | Total body fat mass measured by DXA (Hologic Discovery W, version 12.6) | Mean | Standard Deviation | kg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in Total Body Fat Mass | Change from baseline to 16 weeks in total body fat mass. | Posted | Mean | Standard Error | kg | 16 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Error | lbs | 16 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Error | lbs | 16 weeks |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Ibuprofen and Resistance Exercise Traininig | 0 | 8 | 0 | 8 |
| EG002 | Placebo and Resistance Exercise Training | 0 | 13 | 0 | 13 |
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |