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Physical Activity in Patients With Gynecological Surgery

Primary Purpose

Women Who Underwent Midline Incision, Gynecological Surgery

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Physical activity feedback
Usual care except physical activity measurement
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Women Who Underwent Midline Incision, Gynecological Surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Midline incision, gynecological surgery

Exclusion Criteria:

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental

Control

Arm Description

Patients will receive physical activity feedback and be encouraged to achieve the daily goals of physical activity

Physical activity will be measured but not be informed to patients. She will receive usual care.

Outcomes

Primary Outcome Measures

Physical activity recovery rate
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.

Secondary Outcome Measures

Full Information

First Posted
December 24, 2013
Last Updated
October 28, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02025387
Brief Title
Physical Activity in Patients With Gynecological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Examine whether the measurement and feedback of physical activity increase the physical activity in women who underwent midline incision, gynecological surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women Who Underwent Midline Incision, Gynecological Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients will receive physical activity feedback and be encouraged to achieve the daily goals of physical activity
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Physical activity will be measured but not be informed to patients. She will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity feedback
Intervention Type
Behavioral
Intervention Name(s)
Usual care except physical activity measurement
Primary Outcome Measure Information:
Title
Physical activity recovery rate
Description
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.
Time Frame
Postoperative day 4 and 5

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Midline incision, gynecological surgery Exclusion Criteria: Cannot ambulate Anticipated long term ICU care Cannot wear accelerometer Anticipated discharge before postoperative day 5
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam si
State/Province
Gyeonggi do
ZIP/Postal Code
463707
Country
Korea, Republic of

12. IPD Sharing Statement

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Physical Activity in Patients With Gynecological Surgery

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