NCT02025387

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

3.8 years

First QC Date

December 24, 2013

Last Update Submit

October 28, 2017

Conditions

Women Who Underwent Midline Incision, Gynecological Surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    Postoperative day 4 and 5

Study Arms (2)

Experimental

EXPERIMENTAL

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

Behavioral: Physical activity feedback

Control

SHAM COMPARATOR

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

Behavioral: Usual care except physical activity measurement

Interventions

Physical activity feedbackBEHAVIORAL
Experimental
Usual care except physical activity measurementBEHAVIORAL
Control

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Midline incision, gynecological surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463707, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 24, 2013

First Posted

January 1, 2014

Study Start

December 1, 2013

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations

KR(1)