Post Operative Walking Enhancements for Recovery (POWER) Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Loyola University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT01254851
First received: December 3, 2010
Last updated: September 13, 2011
Last verified: September 2011
  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
Postoperative 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 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.


Estimated Enrollment: 120
Study Start Date: October 2010
Estimated Study Completion Date: April 2012
Primary Completion Date: August 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

  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: Loyola University
ClinicalTrials.gov Identifier: NCT01254851     History of Changes
Other Study ID Numbers: 203031
Study First Received: December 3, 2010
Last Updated: September 13, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 29, 2014