- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05195463
Efficiency of Abdominal Corset and Core Stabilization Exercises in the Treatment of Postpartum Diastasis Recti Abdominis
August 2, 2022 updated by: merve yilmaz menek, Istanbul Medipol University Hospital
Comparison of the Efficiency of Abdominal Corset and Core Stabilization Exercises in the Treatment of Postpartum Diastasis Recti Abdominis
Participants will be randomly divided into three groups as core stabilization group, combination of core stabilization and corset group and only corset group.
Study Overview
Status
Completed
Conditions
Detailed Description
30 volunteer women who were diagnosed with diastasis recti abdominis by an obstetrician in Çamlıca Medipol Hospital, aged between 18-35 and met the inclusion criteria will be included in the study.
Participants will be randomly divided into three groups.
Participants in the first group will do core stabilization exercises for the transversus abdominis muscle 3 days a week for 8 weeks with 10 repetitions.
In the second group, in addition to the first group, core stabilization exercises will be performed by wearing an abdominal corset.
Participants included in the third group will be asked to wear only this corset all day (except for the bathroom) for 8 weeks.
Anthropometric measurements, ultrasonographic evaluation, Visual Analogue Scale (VAS), Edinburgh Postnatal Depression Scale, abdominal muscle strength and endurance, Oswestry Disability Index will be evaluated as pretest and posttest.
Study Type
Interventional
Enrollment (Actual)
45
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
-
-
-
Istanbul, Turkey, 34820
- Istanbul Medipol University
-
-
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
20 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Being between the ages of 20-35,
- Having a normal birth,
- Being at least 6 weeks postpartum when DRA is diagnosed,
- Absence of any musculoskeletal or neurological problems,
- Volunteering to do the exercises
Exclusion Criteria:
- Cesarean delivery,
- Edinburgh Postnatal Depression questionnaire result being >13,
- Having a systemic disorder
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: First group
Core stabilization exercises
|
Women with diastasis recti abdominis will do core stabilization exercises for the transversus abdominis muscle with 10 repetitions 3 days a week for 8 weeks.
The exercises include diaphragmatic breathing exercises, core stabilization exercises for the transversus abdominis muscle, and pelvic floor contractions
|
|
Experimental: Second group
Combination of core stabilization and abdominal corset
|
In this group, in addition to the first group, core stabilization exercises will be performed by wearing an abdominal corset.
Participants will be asked to wear their corsets while performing their exercises.
|
|
Experimental: Third group
Only abdominal corset
|
Participants included in this group will be required to wear only this corset all day (except for the bathroom) for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasanografic measurement
Time Frame: 5 minutes
|
The distance between the rectus muscles will be measured by the obstetrician with ultrasound.
|
5 minutes
|
|
Visual Analogue Scale for pain assessment
Time Frame: 3 minutes
|
The line has a value of 0 at the beginning and a value of 10 at the end.
The patient is asked to indicate the intensity of the pain at rest or during activity.
A value of 0 means no pain, a value of 10 means excruciating pain.
|
3 minutes
|
|
Abdominal muscle strength measurement
Time Frame: 5 minutes
|
The abdominal muscle strength of the participants will be graded from 0 to 5 using manual muscle testing.
|
5 minutes
|
|
Abdominal muscle undurance measurement
Time Frame: 5 minutes
|
n the measurement of muscle endurance, the participants will be asked to stand as long as they can in their position during the muscle strength measurement.
|
5 minutes
|
|
Edinburgh Postnatal Depression Scale
Time Frame: 5 minutes
|
The scale is used to determine the risk of depression in the postpartum period and to measure the change in level and severity.
Minimum value is 0 and maximum value is 30.
Cut-off score of 13 is used to distinguish depressed from nondepressed women.
High scores means worse outcomes.
|
5 minutes
|
|
Oswestry Disability Index for assesment of pain and quality of life
Time Frame: 5 minutes
|
It is a questionnaire evaluating individuals' participation in activities of daily living due to low back pain.
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight measurement
Time Frame: 2 minutes
|
Weight measurement in kilograms will be recorded with weighing machine.
|
2 minutes
|
|
Height measurement
Time Frame: 2 minutes
|
Height measurement in meters will be recorded with tape measure
|
2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: MERVE YILMAZ MENEK, Medipol University
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 (Actual)
February 1, 2022
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
July 1, 2022
Study Registration Dates
First Submitted
January 4, 2022
First Submitted That Met QC Criteria
January 4, 2022
First Posted (Actual)
January 19, 2022
Study Record Updates
Last Update Posted (Actual)
August 4, 2022
Last Update Submitted That Met QC Criteria
August 2, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Merveylmz.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
We will publish a manuscript about the result of this study for sharing results of the data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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