Post Operative Walking Enhancements for Recovery (POWER) Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Linda Brubaker, Loyola University
ClinicalTrials.gov Identifier:
NCT01254851
First received: December 3, 2010
Last updated: June 15, 2015
Last verified: June 2015

December 3, 2010
June 15, 2015
October 2010
June 2011   (final data collection date for primary outcome measure)
Number of Steps Taken in 24 Hours. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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.
Number of steps taken in twentyfour hours. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
The primary outcome assessed will be number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.
Complete list of historical versions of study NCT01254851 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Post Operative Walking Enhancements for Recovery (POWER) Trial
Post Operative Walking Enhancements for Recovery (POWER) Trial

This study is a non-blinded randomized controlled trial. Consenting participants will be randomized to routine post-operative ambulation vs. goal-augmented post-operative care (they will be given a goal number of steps to take on each post-operative day) following in-patient gynecologic surgery.

This study is a non-blinded randomized controlled trial. Consenting participants will be randomized to routine post-operative ambulation vs. treadmill-augmented post-operative care (placement of non-motorized treadmill in their room) following in-patient gynecologic surgery.

We will approach all women undergoing gynecologic procedures that are expected to ambulate within 12 hours of their operation and are anticipated to remain hospitalized at least 18 hours. Following confirmation of eligibility, we will enroll subjects either in the clinic when they are being consented for their gynecologic procedure or upon presentation to the hospital the day of their procedure. Randomization will occur at the completion of the gynecologic procedure when it has been confirmed by the primary surgeon that the patient is able to ambulate independently within 12 hours after completion of the procedure. At that time, participants will be randomized using opaque envelopes prepared by the study statistician in a 1:1 ratio to receive usual post-operative care or treadmill-augmented care.

All patients will have a pedometer placed on their person in the post-anesthesia recovery unit (PACU) which will be removed the day of their discharge. The primary outcome assessed will be number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.

Pedometer will be placed on patients using a lanyard and pedometer clip in the recovery room. No participant will start ambulation without physician's clinical order. When the patient is ready for the first ambulation she will be accompanied by a nurse to sit up in a chair. Once the patient is able to ambulate herself she may ambulate in her room or in the hallway or if randomized to treadmill group she will be able to ambulate on the treadmill. She will be wearing her pedometer at all times until discharge from Loyola.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
External Causes of Morbidity and Mortality
Behavioral: goal-augmented post-operative care
Patients in the goal-augmented post-operative care group will be given a goal number of steps to take on each post-operative day following in-patient gynecologic surgery.
  • Active Comparator: goal-augmented post-operative care.
    Patients in this group will be given a goal number of steps to take on each post-operative day.
    Intervention: Behavioral: goal-augmented post-operative care
  • No Intervention: Usual care
    routine post-operative ambulation
Liebermann M, Awad M, Dejong M, Rivard C, Sinacore J, Brubaker L. Ambulation of hospitalized gynecologic surgical patients: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):533-7. doi: 10.1097/AOG.0b013e318280d50a.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Independent ambulation pre-operatively
  • Undergoing gynecologic procedure
  • Expected to ambulate within 12 hours of their procedure

Exclusion Criteria:

  • Children under the age of 18
  • Inability to ambulate independently prior to their surgery
  • Primary surgeon does not want patient to ambulate within 12 hours of procedure
  • English is not the primary language spoken by the patient
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01254851
203031
No
Linda Brubaker, Loyola University
Loyola University
Not Provided
Principal Investigator: Linda Brubaker, M.D. Loyola University
Loyola University
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP