SarcopeniaNCT01083901
Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training
A study testing Resistance training in people with Sarcopenia and Osteoporosis, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Osteoporosis, Aging
- What is being tested?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Sarcopenia, Osteoporosis, Aging
- Being tested
- Resistance training
- Medical subject headings
- Sarcopenia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
high intensity progressive resistance exercise training
| Study group | Role | What they receive |
|---|---|---|
| Resistance training with Acetaminophen | Experimental | Acetaminophen Receives: Behavioral: Resistance training |
| Resistance Training with ibuprofen | Experimental | Ibuprofen Receives: Behavioral: Resistance training |
| placebo | Placebo comparator | Placebo Receives: Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 16 weeks
Secondary outcomes (3)
Change in Total Body Fat Mass
Change from baseline to 16 weeks in total body fat mass.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMay 2006
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Catherine Jankowski, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083901
- Sponsor's protocol ID
- 06-0343
- Other IDs
- R21AG027809
- Status last verified
- Jun 2013
- First submitted
- 8 Mar 2010
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training
- ClinicalTrials.gov ID
- NCT01083901
- Acronym / sponsor ID
- 06-0343
- Conditions
- Sarcopenia, Osteoporosis, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Posted 8 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance training with Acetaminophen | Experimental | Behavioral: Resistance trainingAcetaminophen |
| Resistance Training with ibuprofen | Experimental | Behavioral: Resistance trainingIbuprofen |
| placebo | Placebo comparator | Behavioral: Resistance trainingPlacebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance traininghigh intensity progressive resistance exercise training | Behavioural | Resistance Training with ibuprofen, Resistance training with Acetaminophen, placebo |
Primary outcome
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)
3 secondary outcomes
Change in Total Body Fat Mass
Time frame: 16 weeks
Changes in Upper Body Strength.
Time frame: 16 weeks
Change in Lower Body Strength
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Jankowski, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Sarcopenia and Osteoporosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Body Fat-free Mass (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.