NCT05195463

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

January 4, 2022

Last Update Submit

August 2, 2022

Conditions

Keywords

diastasis recti abdominiscore stabilization exercisephysiotherapy

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

EXPERIMENTAL

Core stabilization exercises

Other: Exercise intervention

Second group

EXPERIMENTAL

Combination of core stabilization and abdominal corset

Other: Exercise intervention by wearing abdominal corset

Third group

EXPERIMENTAL

Only abdominal corset

Other: Corset intervention

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

First group

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.

Second group

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

Third group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Location

Study Officials

  • MERVE YILMAZ MENEK

    Medipol University

    STUDY DIRECTOR

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.

Locations