Women Who Underwent Midline Incision, Gynecological SurgeryNCT02025387
Physical Activity in Patients With Gynecological Surgery
A study testing Physical activity feedback in people with Women Who Underwent Midline Incision, Gynecological Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Examine whether the measurement and feedback of physical activity increase the physical activity in women who underwent midline incision, gynecological surgery Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Women Who Underwent Midline Incision, Gynecological Surgery
- What is being tested?
- Physical activity feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Midline incision, gynecological surgery
Who cannot join
- Cannot ambulate
- Anticipated long term ICU care
- Cannot wear accelerometer
- Anticipated discharge before postoperative day 5
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463707
About this study
Examine whether the measurement and feedback of physical activity increase the physical activity in women who underwent midline incision, gynecological surgery
- Being tested
- Physical activity feedback, Usual care except physical activity measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity feedbackBehavioural
Usual care except physical activity measurementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients will receive physical activity feedback and be encouraged to achieve the daily goals of physical activity Receives: Behavioral: Physical activity feedback |
| Control | Sham comparator | Physical activity will be measured but not be informed to patients. She will receive usual care. Receives: Behavioral: Usual care except physical activity measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 4 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Who Underwent Midline Incision, Gynecological SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kidong Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025387
- Sponsor's protocol ID
- SNUBH_GO_034
- Status last verified
- Oct 2017
- First submitted
- 24 Dec 2013
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Patients With Gynecological Surgery
- ClinicalTrials.gov ID
- NCT02025387
- Acronym / sponsor ID
- SNUBH_GO_034
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examine whether the measurement and feedback of physical activity increase the physical activity in women who underwent midline incision, gynecological surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Physical activity feedbackPatients will receive physical activity feedback and be encouraged to achieve the daily goals of physical activity |
| Control | Sham comparator | Behavioral: Usual care except physical activity measurementPhysical activity will be measured but not be informed to patients. She will receive usual care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Midline incision, gynecological surgery
Key exclusion criteria (4 listed)
- Cannot ambulate
- Anticipated long term ICU care
- Cannot wear accelerometer
- Anticipated discharge before postoperative day 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity feedback | Behavioural | Experimental |
| Usual care except physical activity measurement | Behavioural | Control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity feedback in people with Women Who Underwent Midline Incision, Gynecological Surgery, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity recovery rate (time frame: Postoperative day 4 and 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.