- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01083901
Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Denver
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: placebo
Placebo
|
high intensity progressive resistance exercise training
|
Experimentell: Resistance training with Acetaminophen
Acetaminophen
|
high intensity progressive resistance exercise training
|
Experimentell: Resistance Training with ibuprofen
Ibuprofen
|
high intensity progressive resistance exercise training
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Total Body Fat-free Mass
Tidsram: 16 weeks
|
change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6)
|
16 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Total Body Fat Mass
Tidsram: 16 weeks
|
Change from baseline to 16 weeks in total body fat mass.
|
16 weeks
|
Changes in Upper Body Strength.
Tidsram: 16 weeks
|
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
|
Change in Lower Body Strength
Tidsram: 16 weeks
|
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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 06-0343
- R21AG027809 (U.S.S. NIH-anslag/kontrakt)
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