Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:00 AM
Study NCT ID:
NCT07389993
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm and Breathing Muscle Characteristics in Women With and Without Diastasis Recti Abdominis After Childbirth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inspiratory diaphragm thickness', 'timeFrame': 'Baseline', 'description': 'Diaphragm thickness measured via ultrasound in cm at the end of a full inspiration at a standardized anatomical location.'}, {'measure': 'Expiratory diaphragm thickness', 'timeFrame': 'Baseline', 'description': 'Diaphragm thickness measured via ultrasound in cm at the end of a full expiration at a standardized anatomical location.'}, {'measure': 'Diaphragm excursion', 'timeFrame': 'Baseline', 'description': 'Diaphragm excursion measured via ultrasound in cm during quiet respiration at 60% of inspiratory capacity (IC).'}], 'secondaryOutcomes': [{'measure': 'Maximal Inspiratory Pressure (MIP)', 'timeFrame': 'Baseline', 'description': 'Maximal Inspiratory Pressure (MIP) measured during a forceful inspiratory effort in cmΗ2Ο, using the POWERbreathe KH2 device.'}, {'measure': 'S-Index', 'timeFrame': 'Baseline', 'description': 'S-Index, a strength estimate measured in cmH2O during a forceful inspiration performed using the POWERbreathe KH2 device.'}, {'measure': 'Peak Inspiratory Flow (PIF)', 'timeFrame': 'Baseline', 'description': 'Peak Inspiratory Flow (PIF) measured in L/sec, during the same forceful inspiratory maneuver as SIndex, using the POWERbreathe KH2 device.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diastasis recti', 'diaphragm', 'RUSI', 'inspiratory muscle strength'], 'conditions': ['Diastasis Recti Abdominis (DRA)']}, 'referencesModule': {'references': [{'pmid': '19637295', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30217494', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '38340172', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29494833', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30011041', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33691943', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32607319', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22236541', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14652476', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9423192', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11182126', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16023475', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10956340', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9292460', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11744772', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17304528', 'type': 'BACKGROUND', 'citation': 'Hodges PW, Sapsford R, Pengel LH. Postural and respiratory functions of the pelvic floor muscles. Neurourol Urodyn. 2007;26(3):362-71. doi: 10.1002/nau.20232.'}, {'pmid': '22278713', 'type': 'BACKGROUND', 'citation': 'Sapsford RR, Hodges PW. The effect of abdominal and pelvic floor muscle activation on urine flow in women. Int Urogynecol J. 2012 Sep;23(9):1225-30. doi: 10.1007/s00192-011-1654-2. Epub 2012 Jan 26.'}, {'pmid': '11494188', 'type': 'BACKGROUND', 'citation': 'Sapsford RR, Hodges PW. Contraction of the pelvic floor muscles during abdominal maneuvers. Arch Phys Med Rehabil. 2001 Aug;82(8):1081-8. doi: 10.1053/apmr.2001.24297.'}, {'pmid': '41147924', 'type': 'BACKGROUND', 'citation': 'Skoura A, Billis E, Andriopoulou M, Drakonaki E, Papanikolaou DT, Tsekoura M, Kortianou E, Maroulis I. Intra- and inter-tester reliability of diaphragm thickness and excursion measurements of healthy women using rehabilitative ultrasound imaging across novice examiners. Eur J Transl Myol. 2025 Dec 19;35(4):13907. doi: 10.4081/ejtm.2025.13907. Epub 2025 Oct 27.'}, {'pmid': '23199797', 'type': 'BACKGROUND', 'citation': 'Dimitriadis Z, Kapreli E, Strimpakos N, Oldham J. Respiratory weakness in patients with chronic neck pain. Man Ther. 2013 Jun;18(3):248-53. doi: 10.1016/j.math.2012.10.014. Epub 2012 Nov 28.'}, {'pmid': '24870567', 'type': 'BACKGROUND', 'citation': 'Janssens L, McConnell AK, Pijnenburg M, Claeys K, Goossens N, Lysens R, Troosters T, Brumagne S. Inspiratory muscle training affects proprioceptive use and low back pain. Med Sci Sports Exerc. 2015 Jan;47(1):12-9. doi: 10.1249/MSS.0000000000000385.'}, {'pmid': '16919496', 'type': 'BACKGROUND', 'citation': "O'Sullivan PB, Beales DJ. Changes in pelvic floor and diaphragm kinematics and respiratory patterns in subjects with sacroiliac joint pain following a motor learning intervention: a case series. Man Ther. 2007 Aug;12(3):209-18. doi: 10.1016/j.math.2006.06.006. Epub 2006 Aug 17."}, {'pmid': '30954705', 'type': 'BACKGROUND', 'citation': 'Calvo-Lobo C, Almazan-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P, Rodriguez-Sanz D, Lopez-Lopez D. Ultrasonography comparison of diaphragm thickness and excursion between athletes with and without lumbopelvic pain. Phys Ther Sport. 2019 May;37:128-137. doi: 10.1016/j.ptsp.2019.03.015. Epub 2019 Mar 28.'}, {'pmid': '34061721', 'type': 'BACKGROUND', 'citation': 'Ziaeifar M, Sarrafzadeh J, Noorizadeh Dehkordi S, Arab AM, Haghighatkhah H, Zendehdel Jadehkenari A. Diaphragm thickness, thickness change, and excursion in subjects with and without nonspecific low back pain using B-mode and M-mode ultrasonography. Physiother Theory Pract. 2022 Nov;38(13):2441-2451. doi: 10.1080/09593985.2021.1926022. Epub 2021 Jun 1.'}, {'pmid': '29421851', 'type': 'BACKGROUND', 'citation': 'Mohan V, Paungmali A, Sitilerpisan P, Hashim UF, Mazlan MB, Nasuha TN. Respiratory characteristics of individuals with non-specific low back pain: A cross-sectional study. Nurs Health Sci. 2018 Jun;20(2):224-230. doi: 10.1111/nhs.12406. Epub 2018 Feb 8.'}, {'pmid': '37561174', 'type': 'BACKGROUND', 'citation': 'Kharaji G, ShahAli S, Ebrahimi Takamjani I, Kashanian M, Sarrafzadeh J, Shanbehzadeh S. Ultrasound assessment of the abdominal, diaphragm, and pelvic floor muscles during the respiratory and postural tasks in women with and without postpartum lumbopelvic pain: a case-control study. Int Urogynecol J. 2023 Dec;34(12):2909-2917. doi: 10.1007/s00192-023-05621-2. Epub 2023 Aug 10.'}, {'pmid': '36242869', 'type': 'BACKGROUND', 'citation': 'Denizoglu Kulli H, Gurses HN. Relationship between inter-recti distance, abdominal muscle endurance, pelvic floor functions, respiratory muscle strength, and postural control in women with diastasis recti abdominis. Eur J Obstet Gynecol Reprod Biol. 2022 Dec;279:40-44. doi: 10.1016/j.ejogrb.2022.10.001. Epub 2022 Oct 5.'}, {'pmid': '25377882', 'type': 'BACKGROUND', 'citation': 'Koo P, Gartman EJ, Sethi JM, McCool FD. Physiology in Medicine: physiological basis of diaphragmatic dysfunction with abdominal hernias-implications for therapy. J Appl Physiol (1985). 2015 Jan 15;118(2):142-7. doi: 10.1152/japplphysiol.00276.2014. Epub 2014 Nov 6.'}, {'pmid': '35893409', 'type': 'BACKGROUND', 'citation': 'Marugan-Rubio D, Chicharro JL, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Rodriguez-Sanz D, Vicente-Campos D, Molina-Hernandez N, Calvo-Lobo C. Effectiveness of Ultrasonography Visual Biofeedback of the Diaphragm in Conjunction with Inspiratory Muscle Training on Muscle Thickness, Respiratory Pressures, Pain, Disability, Quality of Life and Pulmonary Function in Athletes with Non-Specific Low Back Pain: A Randomized Clinical Trial. J Clin Med. 2022 Jul 25;11(15):4318. doi: 10.3390/jcm11154318.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nTo 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.", 'detailedDescription': '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.\n\nThe 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.\n\nThis 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.\n\nDiaphragm 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parous adult women from the local community (broader Achaia region) recruited through invitations and referrals and assessed in a clinical research setting.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female sex\n* Aged 18 to 50 years\n* Parous women (at least one previous childbirth)\n* At least 6 months postpartum at the time of assessment (and within 5 years postpartum)\n* Ability to understand and communicate in Greek\n* Willingness to participate and provide informed consent\n\nExclusion Criteria:\n\n* Current pregnancy\n* Delivery within the previous 6 months\n* History of severe chronic respiratory disease (e.g., chronic obstructive pulmonary disease, chronic bronchitis, pulmonary emphysema, pulmonary fibrosis)\n* Presence of connective tissue disorders\n* Presence of neurological disorders\n* Severe musculoskeletal conditions that could affect trunk or respiratory function or limit participation in testing procedures (severe low back pain, sciatica etc.)\n* Previous abdominal surgery, with the exception of cesarean section'}, 'identificationModule': {'nctId': 'NCT07389993', 'acronym': 'DRA-DIAPH', 'briefTitle': 'Diaphragm and Breathing Muscle Characteristics in Women With and Without Diastasis Recti Abdominis After Childbirth', 'organization': {'class': 'OTHER', 'fullName': 'University of Patras'}, 'officialTitle': 'Diaphragm Characteristics and Respiratory Muscle Function in Parous Women With and Without Diastasis Recti Abdominis', 'orgStudyIdInfo': {'id': 'DRA-DIAPHRAGM-PILOT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with diastasis recti abdominis', 'description': 'Parous women diagnosed with diastasis recti abdominis using a standardised ultrasonographic assessment to measure the inter-recti distance (IRD).', 'interventionNames': ['Diagnostic Test: Ultrasonographic assessment of the diaphragm', 'Diagnostic Test: Inspiratory muscle testing']}, {'label': 'Women without diastasis recti abdominis', 'description': 'Parous women without diastasis recti abdominis, as confirmed by standardized ultrasonographic assessment of inter-recti distance (IRD).', 'interventionNames': ['Diagnostic Test: Ultrasonographic assessment of the diaphragm', 'Diagnostic Test: Inspiratory muscle testing']}], 'interventions': [{'name': 'Ultrasonographic assessment of the diaphragm', 'type': 'DIAGNOSTIC_TEST', 'description': 'Rehabilitative ultrasound imaging (RUSI) to assess diaphragm thickness and excursion under specific respiratory maneuvers.', 'armGroupLabels': ['Women with diastasis recti abdominis', 'Women without diastasis recti abdominis']}, {'name': 'Inspiratory muscle testing', 'type': 'DIAGNOSTIC_TEST', 'description': '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).', 'armGroupLabels': ['Women with diastasis recti abdominis', 'Women without diastasis recti abdominis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26504', 'city': 'Pátrai', 'state': 'Achaia', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Anastasia Skoura, PhD', 'role': 'CONTACT', 'email': 'a.skoura@upatras.gr', 'phone': '00306947784948'}, {'name': 'Katerina Afroditi Chalki, BSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}], 'centralContacts': [{'name': 'Anastasia Skoura, PhD', 'role': 'CONTACT', 'email': 'a.skoura@upatras.gr', 'phone': '00306947784948'}, {'name': 'Evdokia Billis, PhD', 'role': 'CONTACT', 'email': 'billis@upatras.gr', 'phone': '00302610962406'}], 'overallOfficials': [{'name': 'Evdokia Billis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Patras'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Patras', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anastasia Skoura', 'investigatorAffiliation': 'University of Patras'}}}}