External Causes of Morbidity and Mortality Clinical Trial
Official title:
Post Operative Walking Enhancements for Recovery (POWER) Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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