NCT01254851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

July 8, 2015

Completed
Last Updated

July 8, 2015

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

December 3, 2010

Results QC Date

April 24, 2012

Last Update Submit

June 15, 2015

Conditions

Keywords

discharge criteria, gynecologic surgery, post-op ambulation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

goal-augmented post-operative care.

ACTIVE COMPARATOR

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

Usual care

NO INTERVENTION

routine post-operative ambulation

Interventions

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.

goal-augmented post-operative care.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Independent ambulation pre-operatively
  • Undergoing gynecologic procedure
  • Expected to ambulate within 12 hours of their procedure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Gottlieb Memorial Hospital

Melrose Park, Illinois, 60160, United States

Location

Related Publications (1)

  • 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.

Limitations and Caveats

Difficulty ensuring that encouragement was given, as we did not quantify the frequency of encouragement by the health care team. Loss of data due to loss of pedometers

Results Point of Contact

Title
Linda Brubaker
Organization
Loyola University Medical Center

Study Officials

  • Linda Brubaker, M.D.

    Loyola University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dean, and Chief Diversity Officer

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 7, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 8, 2015

Results First Posted

July 8, 2015

Record last verified: 2015-06

Locations