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
  Purpose

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 Intervention
External Causes of Morbidity and Mortality
Behavioral: goal-augmented post-operative care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Post Operative Walking Enhancements for Recovery (POWER) Trial

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • 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.


Enrollment: 146
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Loyola University

Additional 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
Study First Received: December 3, 2010
Results First Received: April 24, 2012
Last Updated: June 15, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 26, 2015