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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05195463
Other study ID # Merveylmz.
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date July 1, 2022

Study information

Verified date August 2022
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Participants will be randomly divided into three groups as core stabilization group, combination of core stabilization and corset group and only corset group.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date July 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.
Corset intervention
Participants included in this group will be required to wear only this corset all day (except for the bathroom) for 8 weeks.

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ultrasanografic measurement The distance between the rectus muscles will be measured by the obstetrician with ultrasound. 5 minutes
Primary 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
Primary Abdominal muscle strength measurement The abdominal muscle strength of the participants will be graded from 0 to 5 using manual muscle testing. 5 minutes
Primary 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
Primary 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
Primary 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 Weight measurement Weight measurement in kilograms will be recorded with weighing machine. 2 minutes
Secondary Height measurement Height measurement in meters will be recorded with tape measure 2 minutes
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