Efficiency of Abdominal Corset and Core Stabilization Exercises in the Treatment of Postpartum Diastasis Recti Abdominis
Comparison of the Efficiency of Abdominal Corset and Core Stabilization Exercises in the Treatment of Postpartum Diastasis Recti Abdominis
1 other identifier
interventional
45
1 country
1
Brief Summary
Participants will be randomly divided into three groups as core stabilization group, combination of core stabilization and corset group and only corset group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
January 4, 2022
CompletedFirst Posted
Study publicly available on registry
January 19, 2022
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedAugust 4, 2022
August 1, 2022
4 months
January 4, 2022
August 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Ultrasanografic measurement
The distance between the rectus muscles will be measured by the obstetrician with ultrasound.
5 minutes
Visual Analogue Scale for pain assessment
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
The abdominal muscle strength of the participants will be graded from 0 to 5 using manual muscle testing.
5 minutes
Abdominal muscle undurance measurement
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
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
It is a questionnaire evaluating individuals' participation in activities of daily living due to low back pain.
5 minutes
Secondary Outcomes (2)
Weight measurement
2 minutes
Height measurement
2 minutes
Study Arms (3)
First group
EXPERIMENTALCore stabilization exercises
Second group
EXPERIMENTALCombination of core stabilization and abdominal corset
Third group
EXPERIMENTALOnly abdominal corset
Interventions
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
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.
Participants included in this group will be required to wear only this corset all day (except for the bathroom) for 8 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cesarean delivery,
- Edinburgh Postnatal Depression questionnaire result being \>13,
- Having a systemic disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Medipol University
Istanbul, 34820, Turkey (Türkiye)
Study Officials
- STUDY DIRECTOR
MERVE YILMAZ MENEK
Medipol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will not know which group they belongs to.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
January 4, 2022
First Posted
January 19, 2022
Study Start
February 1, 2022
Primary Completion
June 1, 2022
Study Completion
July 1, 2022
Last Updated
August 4, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
We will publish a manuscript about the result of this study for sharing results of the data with other researchers.