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Post Operative Walking Enhancements for Recovery (POWER) Trial (POWER)

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ClinicalTrials.gov Identifier: NCT01254851
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : July 8, 2015
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Linda Brubaker, Loyola University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
External Causes of Morbidity and Mortality Behavioral: goal-augmented post-operative care Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Post Operative Walking Enhancements for Recovery (POWER) Trial
Study Start Date : October 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery
U.S. FDA Resources

Arm Intervention/treatment
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.
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.
No Intervention: Usual care
routine post-operative ambulation



Primary Outcome Measures :
  1. Number of Steps Taken in 24 Hours. [ Time Frame: 1 day ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254851


Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Gottlieb Memorial Hospital
Melrose Park, Illinois, United States, 60160
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Linda Brubaker, M.D. Loyola University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Linda Brubaker, Professor, Dean, and Chief Diversity Officer, Loyola University
ClinicalTrials.gov Identifier: NCT01254851     History of Changes
Other Study ID Numbers: 203031
First Posted: December 7, 2010    Key Record Dates
Results First Posted: July 8, 2015
Last Update Posted: July 8, 2015
Last Verified: June 2015

Keywords provided by Linda Brubaker, Loyola University:
discharge criteria, gynecologic surgery, post-op ambulation