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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: First group
Core stabilization exercises
Other: Exercise intervention
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
Other: Exercise intervention by wearing 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
Other: Corset intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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