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Diastasis Recti Abdominis (DRA)DRA-BREATHNCT07389993

Diaphragm and Breathing Muscle Characteristics in Women With and Without Diastasis Recti Abdominis After Childbirth

An observational study of Diastasis Recti Abdominis (DRA), run by University of Patras at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Diastasis Recti Abdominis (DRA) is a common condition experienced postpartum, in which the abdominal muscles separate along the midline of the abdomen due to stretching and thinning of the linea alba. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Diastasis Recti Abdominis (DRA)
What is being tested?
Ultrasonographic assessment of the diaphragm and Inspiratory muscle testing
How many people
42 participants
Where
1 siteGreece
Study dates
19 May 2025to 10 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Parous adult women from the local community (broader Achaia region) recruited through invitations and referrals and assessed in a clinical research setting.

Who may be able to join

  • Female sex
  • Aged 18 to 50 years
  • Parous women (at least one previous childbirth)
  • At least 6 months postpartum at the time of assessment (and within 5 years postpartum)
  • Ability to understand and communicate in Greek
  • Willingness to participate and provide informed consent

Who cannot join

  • Current pregnancy
  • Delivery within the previous 6 months
  • History of severe chronic respiratory disease (e.g., chronic obstructive pulmonary disease, chronic bronchitis, pulmonary emphysema, pulmonary fibrosis)
  • Presence of connective tissue disorders
  • Presence of neurological disorders
  • Severe musculoskeletal conditions that could affect trunk or respiratory function or limit participation in testing procedures (severe low back pain, sciatica etc.)
  • Previous abdominal surgery, with the exception of cesarean section

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anastasia Skoura, PhD contact

00306947784948

a.skoura@upatras.gr

Evdokia Billis, PhD contact

00302610962406

billis@upatras.gr

Greece1 site, 1 recruiting
  • Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras

    Pátrai, Achaia, 26504

    Anastasia Skoura, PhD, 00306947784948, a.skoura@upatras.gr

    Katerina Afroditi Chalki, BSc

    Recruiting

Other trials in Greece

About this study

Official title: Diaphragm Characteristics and Respiratory Muscle Function in Parous Women With and Without Diastasis Recti Abdominis

Diastasis Recti Abdominis (DRA) is a common condition experienced postpartum, in which the abdominal muscles separate along the midline of the abdomen due to stretching and thinning of the linea alba. It's a common condition, affecting 66-100% of women post-birth and may be associated with changes in abdominal support, posture, breathing, and trunk function. Although DRA primarily affects the muscles of the abdominal wall, it is speculated that other muscles controlling and stabilizing the trunk, such as the pelvic floor muscles or the diaphragm, might be affected as well. Currently, several studies have investigated the possible negative effects of DRA on pelvic floor function. However, little is known about how it may be related to diaphragm function and accessory breathing muscles.

The purpose of this observational study is to compare diaphragm characteristics and function, and accessory breathing muscle strength in women who have given birth, with and without DRA.

To make this possible, adult parous women from the broader Achaia region are assessed and allocated into two predefined groups based on the presence or absence of DRA. Participants undergo a single assessment session including rehabilitative ultrasound imaging (RUSI) of the diaphragm and standardized tests of inspiratory muscle strength. Additional demographic and clinical information related to pregnancy and physical activity is also recorded. The main hypothesis of this study is that women with DRA demonstrate altered diaphragm function, as well as reduced inspiratory muscle strength, compared to women without DRA. The study aims to improve understanding of the possible relationship between DRA and breathing function after childbirth and to support future research and rehabilitation approaches for women with the condition.

Read the detailed description

Diastasis recti abdominis (DRA) is a common postpartum condition, characterized by stretching and thinning of the linea alba and separation of the two rectus abdominis muscles along the midline of the abdomen. Beyond cosmetic concerns, DRA has been associated with impaired abdominal wall function, altered trunk stability, and potential changes in respiratory mechanics due to the close anatomical and functional relationship between the abdominal muscles and the diaphragm.

The diaphragm plays a central role in respiration and trunk stabilization, working synergistically with the abdominal wall to regulate intra-abdominal pressure (IAP) and postural control. Alterations in abdominal wall integrity, such as those observed in DRA, may therefore influence diaphragm function and mobility, as well as overall respiratory muscle performance. However, evidence regarding the relationship between DRA and diaphragm function currently remains limited.

This observational, cross-sectional study aims to examine diaphragm characteristics and inspiratory muscle strength in parous women with and without DRA. Participants are allocated into two predefined groups according to the presence or absence of DRA, based on a standardized imaging assessment.

Diaphragm function is assessed using rehabilitative ultrasound imaging (RUSI) techniques, performed by a trained physiotherapist, following standardized procedures. Ultrasound images are obtained during specific breathing maneuvers to determine diaphragm thickness and excursion. Inspiratory muscle strength is assessed using a standardized procedure to test maximal inspiratory pressure (MIP), S-Index and Peak Inspiratory Pressure (PIF) using a POWERbreathe KH2 device. All measurements are conducted during a single assessment session, and are led by three experienced physiotherapists. Furthermore, demographic data and relevant obstetric and clinical characteristics, such as age, body mass index (BMI), parity, and time since last delivery, are recorded to describe the study population.

The study aims to explore whether women with DRA demonstrate differences in diaphragm-related parameters and inspiratory muscle strength compared with women without DRA. By improving understanding of the interaction between the abdominal wall and respiratory muscles after childbirth, this research may contribute to the development of more targeted assessment strategies and rehabilitation approaches in postpartum care.

Being tested
Ultrasonographic assessment of the diaphragm, Inspiratory muscle testing
Keywords
diastasis recti, diaphragm, RUSI, inspiratory muscle strength

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasonographic assessment of the diaphragmDiagnostic test

    Rehabilitative ultrasound imaging (RUSI) to assess diaphragm thickness and excursion under specific respiratory maneuvers.

  • Inspiratory muscle testingDiagnostic test

    A standardized inspiratory muscle strength testing procedure using a POWERbreathe KH2 device to assess maximal inspiratory pressure (MIP), S-Index and peak inspiratory flow (PIF).

Study groups in NCT07389993
Study groupRoleWhat they receive
Women with diastasis recti abdominisParous women diagnosed with diastasis recti abdominis using a standardised ultrasonographic assessment to measure the inter-recti distance (IRD).
Receives: Diagnostic Test: Ultrasonographic assessment of the diaphragm; Diagnostic Test: Inspiratory muscle testing
Women without diastasis recti abdominisParous women without diastasis recti abdominis, as confirmed by standardized ultrasonographic assessment of inter-recti distance (IRD).
Receives: Diagnostic Test: Ultrasonographic assessment of the diaphragm; Diagnostic Test: Inspiratory muscle testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inspiratory diaphragm thickness

    Diaphragm thickness measured via ultrasound in cm at the end of a full inspiration at a standardized anatomical location.

    Measured: Baseline

  2. Expiratory diaphragm thickness

    Diaphragm thickness measured via ultrasound in cm at the end of a full expiration at a standardized anatomical location.

    Measured: Baseline

  3. Diaphragm excursion

    Diaphragm excursion measured via ultrasound in cm during quiet respiration at 60% of inspiratory capacity (IC).

    Measured: Baseline

Secondary outcomes (3)
  1. Maximal Inspiratory Pressure (MIP)

    Maximal Inspiratory Pressure (MIP) measured during a forceful inspiratory effort in cmΗ2Ο, using the POWERbreathe KH2 device.

    Measured: Baseline

  2. S-Index

    S-Index, a strength estimate measured in cmH2O during a forceful inspiration performed using the POWERbreathe KH2 device.

    Measured: Baseline

  3. Peak Inspiratory Flow (PIF)

    Peak Inspiratory Flow (PIF) measured in L/sec, during the same forceful inspiratory maneuver as SIndex, using the POWERbreathe KH2 device.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start19 May 2025
  3. Primary completion3 Apr 2026
  4. Study completion10 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07389993
Sponsor's protocol ID
DRA-BREATH-PILOT
Acronym
DRA-BREATH
Status last verified
Jun 2026
First submitted
28 Jan 2026
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Beer GM, Schuster A, Seifert B, Manestar M, Mihic-Probst D, Weber SA. The normal width of the linea alba in nulliparous women. Clin Anat. 2009 Sep;22(6):706-11. doi: 10.1002/ca.20836.

    PubMed 19637295
  • Benjamin DR, Frawley HC, Shields N, van de Water ATM, Taylor NF. Relationship between diastasis of the rectus abdominis muscle (DRAM) and musculoskeletal dysfunctions, pain and quality of life: a systematic review. Physiotherapy. 2019 Mar;105(1):24-34. doi: 10.1016/j.physio.2018.07.002. Epub 2018 Jul 24.

    PubMed 30217494
  • Skoura A, Billis E, Papanikolaou DT, Xergia S, Tsarbou C, Tsekoura M, Kortianou E, Maroulis I. Diastasis Recti Abdominis Rehabilitation in the Postpartum Period: A Scoping Review of Current Clinical Practice. Int Urogynecol J. 2024 Mar;35(3):491-520. doi: 10.1007/s00192-024-05727-1. Epub 2024 Feb 10.

    PubMed 38340172
  • Mota P, Pascoal AG, Carita AI, Bo K. Normal width of the inter-recti distance in pregnant and postpartum primiparous women. Musculoskelet Sci Pract. 2018 Jun;35:34-37. doi: 10.1016/j.msksp.2018.02.004. Epub 2018 Feb 20.

    PubMed 29494833
  • Hills NF, Graham RB, McLean L. Comparison of Trunk Muscle Function Between Women With and Without Diastasis Recti Abdominis at 1 Year Postpartum. Phys Ther. 2018 Oct 1;98(10):891-901. doi: 10.1093/ptj/pzy083.

    PubMed 30011041
  • Gluppe S, Ellstrom Engh M, Kari B. Women with diastasis recti abdominis might have weaker abdominal muscles and more abdominal pain, but no higher prevalence of pelvic floor disorders, low back and pelvic girdle pain than women without diastasis recti abdominis. Physiotherapy. 2021 Jun;111:57-65. doi: 10.1016/j.physio.2021.01.008. Epub 2021 Feb 13.

    PubMed 33691943
  • Boussuges A, Rives S, Finance J, Bregeon F. Assessment of diaphragmatic function by ultrasonography: Current approach and perspectives. World J Clin Cases. 2020 Jun 26;8(12):2408-2424. doi: 10.12998/wjcc.v8.i12.2408.

    PubMed 32607319
  • Kolar P, Sulc J, Kyncl M, Sanda J, Cakrt O, Andel R, Kumagai K, Kobesova A. Postural function of the diaphragm in persons with and without chronic low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):352-62. doi: 10.2519/jospt.2012.3830. Epub 2011 Dec 21.

    PubMed 22236541
  • Hodges P, Kaigle Holm A, Holm S, Ekstrom L, Cresswell A, Hansson T, Thorstensson A. Intervertebral stiffness of the spine is increased by evoked contraction of transversus abdominis and the diaphragm: in vivo porcine studies. Spine (Phila Pa 1976). 2003 Dec 1;28(23):2594-601. doi: 10.1097/01.BRS.0000096676.14323.25.

    PubMed 14652476
  • Hodges PW, Butler JE, McKenzie DK, Gandevia SC. Contraction of the human diaphragm during rapid postural adjustments. J Physiol. 1997 Dec 1;505 ( Pt 2)(Pt 2):539-48. doi: 10.1111/j.1469-7793.1997.539bb.x.

    PubMed 9423192
  • Hodges PW, Cresswell AG, Daggfeldt K, Thorstensson A. In vivo measurement of the effect of intra-abdominal pressure on the human spine. J Biomech. 2001 Mar;34(3):347-53. doi: 10.1016/s0021-9290(00)00206-2.

    PubMed 11182126
  • Hodges PW, Eriksson AE, Shirley D, Gandevia SC. Intra-abdominal pressure increases stiffness of the lumbar spine. J Biomech. 2005 Sep;38(9):1873-80. doi: 10.1016/j.jbiomech.2004.08.016.

    PubMed 16023475
  • Hodges PW, Gandevia SC. Changes in intra-abdominal pressure during postural and respiratory activation of the human diaphragm. J Appl Physiol (1985). 2000 Sep;89(3):967-76. doi: 10.1152/jappl.2000.89.3.967.

    PubMed 10956340
  • Hodges PW, Gandevia SC, Richardson CA. Contractions of specific abdominal muscles in postural tasks are affected by respiratory maneuvers. J Appl Physiol (1985). 1997 Sep;83(3):753-60. doi: 10.1152/jappl.1997.83.3.753.

    PubMed 9292460
  • Hodges PW, Heijnen I, Gandevia SC. Postural activity of the diaphragm is reduced in humans when respiratory demand increases. J Physiol. 2001 Dec 15;537(Pt 3):999-1008. doi: 10.1111/j.1469-7793.2001.00999.x.

    PubMed 11744772

Questions about this trial

What is this clinical trial studying?

An observational study of Diastasis Recti Abdominis (DRA), run by University of Patras at 1 site in Greece.

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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. 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 Greece. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anastasia Skoura, PhD (00306947784948, a.skoura@upatras.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inspiratory diaphragm thickness (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07389993, which also lists 29 linked publications.

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 9 Jun 2026.

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