Trial Outcomes & Findings for Post Operative Walking Enhancements for Recovery (POWER) Trial (NCT NCT01254851)
NCT ID: NCT01254851
Last Updated: 2015-07-08
Results Overview
The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.
COMPLETED
NA
146 participants
1 day
2015-07-08
Participant Flow
This randomized controlled trial enrolled patients who were going to undergo gynecologic surgery were enrolled from 1/11-6/11 at Loyola University Medical Center .We approached adult (\>18 years) English speaking women prior to undergoing major gynecologic surgery who were expected to have at least a 24-hour hospital stay post-operatively.
All Enrolled patients were randomized to a group. Those patients who were enrolled but not included in statistical analysis had their data lost due to lost pedometer.
Participant milestones
| Measure |
Goal-augmented Post-operative Care.
Patients in this group will be given a goal number of steps to take on each post-operative day.
|
Usual Care
routine post-operative ambulation
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
77
|
|
Overall Study
COMPLETED
|
61
|
68
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Operative Walking Enhancements for Recovery (POWER) Trial
Baseline characteristics by cohort
| Measure |
Goal-augmented Post-operative Care.
n=69 Participants
Patients in this group will be given a goal number of steps to take on each post-operative day.
|
Usual Care
n=77 Participants
routine post-operative ambulation
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
53.9 years
STANDARD_DEVIATION 13.27 • n=107 Participants
|
54.98 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=99 Participants
|
77 participants
n=107 Participants
|
146 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: The analysis is an intention to treat (ITT) analysis comprising all participants who were randomized.
The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.
Outcome measures
| Measure |
Goal-augmented Post-operative Care.
n=69 Participants
Patients in this group will be given a goal number of steps to take on each post-operative day.
|
Usual Care
n=77 Participants
routine post-operative ambulation
|
|---|---|---|
|
Number of Steps Taken in 24 Hours.
|
80 Steps
Interval 0.0 to 2353.0
|
87 Steps
Interval 0.0 to 3576.0
|
Adverse Events
Goal-augmented Post-operative Care.
Usual Care
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