Physical Activity in Patients With Gynecological Surgery

October 28, 2017 updated by: Kidong Kim, Seoul National University Hospital
Examine whether the measurement and feedback of physical activity increase the physical activity in women who underwent midline incision, gynecological surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi do
      • Seongnam si, Gyeonggi do, Korea, Republic of, 463707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Midline incision, gynecological surgery

Exclusion Criteria:

  • Cannot ambulate
  • Anticipated long term ICU care
  • Cannot wear accelerometer
  • Anticipated discharge before postoperative day 5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Patients will receive physical activity feedback and be encouraged to achieve the daily goals of physical activity
Behavioral: Physical activity feedback
Sham Comparator: Control
Physical activity will be measured but not be informed to patients. She will receive usual care.
Behavioral: Usual care except physical activity measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity recovery rate
Time Frame: Postoperative day 4 and 5

Baseline physical activity is measured before admission. Specifically, on presurgery day 3 and 4, patients wear accelerometer. The average physical activity of presurgery day 3 and 4 is calculated and be regarded as baseline physical activity.

After surgery, the average physical activity of postoperative day 4 and 5 is calculated. The ratio of the average physical activity of postoperative day 4 and 5 versus baseline physical activity is estimated. The ratio is physical activity recovery rate.
Postoperative day 4 and 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

December 24, 2013

First Submitted That Met QC Criteria

December 27, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 28, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_GO_034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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