Post Operative Walking Enhancements for Recovery (POWER) Trial

External Causes of Morbidity and Mortality Clinical Trial

— POWER  

Official title:

Post Operative Walking Enhancements for Recovery (POWER) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254851
• Other study ID #: 203031
• Status: Completed
• Phase: N/A
• First received: December 3, 2010
• Last updated: June 15, 2015
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2015
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• External Causes of Morbidity and Mortality

Intervention

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.

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois
United States	Gottlieb Memorial Hospital	Melrose Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Steps Taken in 24 Hours.	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.	1 day	No