Post Operative Walking Enhancements for Recovery (POWER) Trial

NCT ID: NCT01254851

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-06-30

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.

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.

Conditions

External Causes of Morbidity and Mortality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

goal-augmented post-operative care.

Patients in this group will be given a goal number of steps to take on each post-operative day.

Group Type: ACTIVE_COMPARATOR

goal-augmented post-operative care

Intervention Type: BEHAVIORAL

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.

Usual care

routine post-operative ambulation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Linda Brubaker

Professor, Dean, and Chief Diversity Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda Brubaker, M.D.

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Gottlieb Memorial Hospital

Melrose Park, Illinois, United States

Countries

United States

References

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):533-537. doi: 10.1097/AOG.0b013e318280d50a.

Reference Type: DERIVED

PMID: 23635615 (View on PubMed)

Other Identifiers

203031

Identifier Type: -

Identifier Source: org_study_id