Diastasis RectiNCT05195463
Efficiency of Abdominal Corset and Core Stabilization Exercises in the Treatment of Postpartum Diastasis Recti Abdominis
A study testing Exercise intervention, Exercise intervention by wearing abdominal corset and Corset intervention in people with Diastasis Recti, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Diastasis Recti
- What is being tested?
- Exercise intervention, Exercise intervention by wearing abdominal corset and Corset intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Cesarean delivery,
- Edinburgh Postnatal Depression questionnaire result being >13,
- Having a systemic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diastasis Recti
- Being tested
- Exercise intervention, Exercise intervention by wearing abdominal corset, Corset intervention
- Keywords
- diastasis recti abdominis, core stabilization exercise, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 corsetOther
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 interventionOther
Participants included in this group will be required to wear only this corset all day (except for the bathroom) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| First group | Experimental | Core stabilization exercises Receives: Other: Exercise intervention |
| Second group | Experimental | Combination of core stabilization and abdominal corset Receives: Other: Exercise intervention by wearing abdominal corset |
| Third group | Experimental | Only abdominal corset Receives: Other: Corset intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasanografic measurement
The distance between the rectus muscles will be measured by the obstetrician with ultrasound.
Measured: 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.
Measured: 3 minutes
Abdominal muscle strength measurement
The abdominal muscle strength of the participants will be graded from 0 to 5 using manual muscle testing.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 minutes
Secondary outcomes (2)
Weight measurement
Weight measurement in kilograms will be recorded with weighing machine.
Measured: 2 minutes
Height measurement
Height measurement in meters will be recorded with tape measure
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Feb 2022
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis RectiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve yilmaz menek, Istanbul Medipol University Hospital
- Investigators
- MERVE YILMAZ MENEK, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195463
- Sponsor's protocol ID
- Merveylmz.
- Status last verified
- Aug 2022
- First submitted
- 4 Jan 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will publish a manuscript about the result of this study for sharing results of the data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Abdominal Corset and Core Stabilization Exercises in the Treatment of Postpartum Diastasis Recti Abdominis
- ClinicalTrials.gov ID
- NCT05195463
- Acronym / sponsor ID
- Merveylmz.
- Conditions
- Diastasis Recti
- Keywords
- diastasis recti abdominis, core stabilization exercise, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be randomly divided into three groups as core stabilization group, combination of core stabilization and corset group and only corset group.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First group | Experimental | Other: Exercise interventionCore stabilization exercises |
| Second group | Experimental | Other: Exercise intervention by wearing abdominal corsetCombination of core stabilization and abdominal corset |
| Third group | Experimental | Other: Corset interventionOnly abdominal corset |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Cesarean delivery,
- Edinburgh Postnatal Depression questionnaire result being >13,
- Having a systemic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionWomen 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 | Other | First group |
| Exercise intervention by wearing abdominal corsetIn 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. | Other | Second group |
| Corset interventionParticipants included in this group will be required to wear only this corset all day (except for the bathroom) for 8 weeks. | Other | Third group |
Primary outcome
Ultrasanografic measurement
Time frame: 5 minutes
The distance between the rectus muscles will be measured by the obstetrician with ultrasound.
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.
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.
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.
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.
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.
2 secondary outcomes
Weight measurement
Time frame: 2 minutes
Height measurement
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No. We will publish a manuscript about the result of this study for sharing results of the data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MERVE YILMAZ MENEK study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention, Exercise intervention by wearing abdominal corset and Corset intervention in people with Diastasis Recti, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasanografic measurement (time frame: 5 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.