Trial Outcomes & Findings for Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training (NCT NCT01083901)
NCT ID: NCT01083901
Last Updated: 2013-06-24
Results Overview
change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
16 weeks
Results posted on
2013-06-24
Participant Flow
Participants were enrolled from Dec 2006 to Jan 2010. They were recruited from the greater Denver area using advertisements.
Volunteers who did not meet inclusion criteria were excluded from the study during the initial screening visits prior to randomization to the study arms.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
8
|
13
|
|
Overall Study
COMPLETED
|
12
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training
Baseline characteristics by cohort
| Measure |
Acetaminophen and Resistance Exercise
n=13 Participants
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.
|
Ibuprofen and Resistance Exercise
n=8 Participants
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.
|
Placebo and Resistance Exercise
n=13 Participants
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
United States
|
63 years
STANDARD_DEVIATION 5 • n=5 Participants
|
58 years
STANDARD_DEVIATION 6 • n=7 Participants
|
62 years
STANDARD_DEVIATION 7 • n=5 Participants
|
61 years
STANDARD_DEVIATION 6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Height
|
181 cm
STANDARD_DEVIATION 8 • n=5 Participants
|
178 cm
STANDARD_DEVIATION 10 • n=7 Participants
|
176 cm
STANDARD_DEVIATION 7 • n=5 Participants
|
178 cm
STANDARD_DEVIATION 6.4 • n=4 Participants
|
|
Weight
|
94.5 kg
STANDARD_DEVIATION 16.6 • n=5 Participants
|
89.3 kg
STANDARD_DEVIATION 12.5 • n=7 Participants
|
87.9 kg
STANDARD_DEVIATION 18.0 • n=5 Participants
|
90.4 kg
STANDARD_DEVIATION 16.4 • n=4 Participants
|
|
Fat-free mass
|
65.2 kg
STANDARD_DEVIATION 6.1 • n=5 Participants
|
63.5 kg
STANDARD_DEVIATION 8.2 • n=7 Participants
|
62.7 kg
STANDARD_DEVIATION 9.1 • n=5 Participants
|
63.4 kg
STANDARD_DEVIATION 8.0 • n=4 Participants
|
|
Fat mass
|
29.3 kg
STANDARD_DEVIATION 12.6 • n=5 Participants
|
25.8 kg
STANDARD_DEVIATION 5.3 • n=7 Participants
|
25.2 kg
STANDARD_DEVIATION 9.6 • n=5 Participants
|
27.0 kg
STANDARD_DEVIATION 10.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All participants with baseline and 16 week data were included in the analysis (i.e., intention-to-treat).
change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6)
Outcome measures
| Measure |
Acetaminophen and Resistance Exercise Training
n=12 Participants
|
Ibuprofen and Resistance Exercise Training
n=6 Participants
|
Placebo and Resistance Exercise Training
n=11 Participants
|
|---|---|---|---|
|
Change in Total Body Fat-free Mass
|
1.5 kg
Standard Error 0.6
|
2.3 kg
Standard Error 0.9
|
0.7 kg
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 16 weeksChange from baseline to 16 weeks in total body fat mass.
Outcome measures
| Measure |
Acetaminophen and Resistance Exercise Training
n=12 Participants
|
Ibuprofen and Resistance Exercise Training
n=6 Participants
|
Placebo and Resistance Exercise Training
n=11 Participants
|
|---|---|---|---|
|
Change in Total Body Fat Mass
|
-1.5 kg
Standard Error 0.6
|
-1.4 kg
Standard Error 0.9
|
-0.2 kg
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 16 weeksStrength 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.
Outcome measures
| Measure |
Acetaminophen and Resistance Exercise Training
n=12 Participants
|
Ibuprofen and Resistance Exercise Training
n=6 Participants
|
Placebo and Resistance Exercise Training
n=11 Participants
|
|---|---|---|---|
|
Changes in Upper Body Strength.
|
19.5 lbs
Standard Error 5.5
|
35.2 lbs
Standard Error 8.6
|
26.5 lbs
Standard Error 5.8
|
SECONDARY outcome
Timeframe: 16 weeksStrength was measured using the one-repetition maximum method. Lower body strength was a composite of knee flexion, knee extension, and leg press strength.
Outcome measures
| Measure |
Acetaminophen and Resistance Exercise Training
n=12 Participants
|
Ibuprofen and Resistance Exercise Training
n=6 Participants
|
Placebo and Resistance Exercise Training
n=11 Participants
|
|---|---|---|---|
|
Change in Lower Body Strength
|
33.1 lbs
Standard Error 9.4
|
40.8 lbs
Standard Error 14.6
|
18.0 lbs
Standard Error 9.8
|
Adverse Events
Acetaminophen and Resistance Exercise Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ibuprofen and Resistance Exercise Traininig
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo and Resistance Exercise Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place