Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-02 @ 8:19 AM
Study NCT ID:
NCT05916833
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2023-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Hypopressive Breathing and Noble Technique on DRA in Postpartum Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2023-06-14', 'studyFirstSubmitQcDate': '2023-06-14', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified OSWESTRY Low Back pain Index (ODI)', 'timeFrame': '12 weeks', 'description': 'The Oswestry Low Back Pain Disability Index is a 10-point patient-reported outcome questionnaire that was first published in 1980. It is regarded as the "gold standard" for assessing quality of life (QoL) impairment and disability in persons with low back pain'}, {'measure': 'IFSAC (Inventory of Functional Status After Childbirth)', 'timeFrame': '12 weeks', 'description': 'The IFSAC consists of five subscales and 36 items, that is, infant care (6 items), personal care (8items), household activities (12 items), social and community activities (6 items), and occupational activities (4 items). The questionnaires are rated on a 4-point Likert scale and mean scores were calculated with one point being the lowest and four points being the highest scores possible.'}, {'measure': 'Numeric Pain Rating Scale (NPRS):', 'timeFrame': '1 day', 'description': 'The numeric pain rating scale (NPRS), a scoring system that quantifies pain on a scale from 0 (no pain) to 10 (worst possible agony), was used to determine the pain score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypopressive', 'noble technique', 'DRA', 'postpartum women'], 'conditions': ['Diastasis Recti Abdominis']}, 'referencesModule': {'references': [{'pmid': '11181006', 'type': 'BACKGROUND', 'citation': 'Axer H, Keyserlingk DG, Prescher A. Collagen fibers in linea alba and rectus sheaths. I. General scheme and morphological aspects. J Surg Res. 2001 Mar;96(1):127-34. doi: 10.1006/jsre.2000.6070.'}, {'pmid': '17208034', 'type': 'BACKGROUND', 'citation': 'Coldron Y, Stokes MJ, Newham DJ, Cook K. Postpartum characteristics of rectus abdominis on ultrasound imaging. Man Ther. 2008 May;13(2):112-21. doi: 10.1016/j.math.2006.10.001. Epub 2007 Jan 5.'}, {'pmid': '8677279', 'type': 'BACKGROUND', 'citation': 'Gilleard WL, Brown JM. Structure and function of the abdominal muscles in primigravid subjects during pregnancy and the immediate postbirth period. Phys Ther. 1996 Jul;76(7):750-62. doi: 10.1093/ptj/76.7.750.'}, {'type': 'BACKGROUND', 'citation': '4. Gómez FR, Senín-Camargo FJ, Cancela-Cores Á, Patiño-Núñez S, Carballo-Costa L. C0083 Effect of a hipopressive abdominal exercise program on inter-rectus abdominis muscles distance in postpartum.'}, {'pmid': '27324871', 'type': 'BACKGROUND', 'citation': 'Sperstad JB, Tennfjord MK, Hilde G, Ellstrom-Engh M, Bo K. Diastasis recti abdominis during pregnancy and 12 months after childbirth: prevalence, risk factors and report of lumbopelvic pain. Br J Sports Med. 2016 Sep;50(17):1092-6. doi: 10.1136/bjsports-2016-096065. Epub 2016 Jun 20.'}, {'pmid': '2968609', 'type': 'BACKGROUND', 'citation': 'Boissonnault JS, Blaschak MJ. Incidence of diastasis recti abdominis during the childbearing year. Phys Ther. 1988 Jul;68(7):1082-6. doi: 10.1093/ptj/68.7.1082.'}, {'pmid': '29512814', 'type': 'BACKGROUND', 'citation': 'Michalska A, Rokita W, Wolder D, Pogorzelska J, Kaczmarczyk K. Diastasis recti abdominis - a review of treatment methods. Ginekol Pol. 2018;89(2):97-101. doi: 10.5603/GP.a2018.0016.'}, {'pmid': '16958723', 'type': 'BACKGROUND', 'citation': 'Logsdon MC, Wisner KL, Pinto-Foltz MD. The impact of postpartum depression on mothering. J Obstet Gynecol Neonatal Nurs. 2006 Sep-Oct;35(5):652-8. doi: 10.1111/j.1552-6909.2006.00087.x.'}, {'pmid': '12949031', 'type': 'BACKGROUND', 'citation': "Gjerdingen DK, Center BA. First-time parents' prenatal to postpartum changes in health, and the relation of postpartum health to work and partner characteristics. J Am Board Fam Pract. 2003 Jul-Aug;16(4):304-11. doi: 10.3122/jabfm.16.4.304."}, {'pmid': '33228602', 'type': 'BACKGROUND', 'citation': "Eriksson Crommert M, Petrov Fieril K, Gustavsson C. Women's experiences of living with increased inter-recti distance after childbirth: an interview study. BMC Womens Health. 2020 Nov 23;20(1):260. doi: 10.1186/s12905-020-01123-1."}, {'pmid': '35908286', 'type': 'BACKGROUND', 'citation': 'Arranz-Martin B, Navarro-Brazalez B, Sanchez-Sanchez B, McLean L, Carazo-Diaz C, Torres-Lacomba M. The Impact of Hypopressive Abdominal Exercise on Linea Alba Morphology in Women Who Are Postpartum: A Short-Term Cross-Sectional Study. Phys Ther. 2022 Aug 4;102(8):pzac086. doi: 10.1093/ptj/pzac086.'}, {'pmid': '36140446', 'type': 'BACKGROUND', 'citation': 'Radhakrishnan M, Ramamurthy K. Efficacy and Challenges in the Treatment of Diastasis Recti Abdominis-A Scoping Review on the Current Trends and Future Perspectives. Diagnostics (Basel). 2022 Aug 24;12(9):2044. doi: 10.3390/diagnostics12092044.'}, {'pmid': '27363572', 'type': 'BACKGROUND', 'citation': 'Lee D, Hodges PW. Behavior of the Linea Alba During a Curl-up Task in Diastasis Rectus Abdominis: An Observational Study. J Orthop Sports Phys Ther. 2016 Jul;46(7):580-9. doi: 10.2519/jospt.2016.6536.'}, {'pmid': '30337344', 'type': 'BACKGROUND', 'citation': 'Davenport MH, Marchand AA, Mottola MF, Poitras VJ, Gray CE, Jaramillo Garcia A, Barrowman N, Sobierajski F, James M, Meah VL, Skow RJ, Riske L, Nuspl M, Nagpal TS, Courbalay A, Slater LG, Adamo KB, Davies GA, Barakat R, Ruchat SM. Exercise for the prevention and treatment of low back, pelvic girdle and lumbopelvic pain during pregnancy: a systematic review and meta-analysis. Br J Sports Med. 2019 Jan;53(2):90-98. doi: 10.1136/bjsports-2018-099400. Epub 2018 Oct 18.'}, {'pmid': '26474542', 'type': 'BACKGROUND', 'citation': 'van de Water AT, Benjamin DR. Measurement methods to assess diastasis of the rectus abdominis muscle (DRAM): A systematic review of their measurement properties and meta-analytic reliability generalisation. Man Ther. 2016 Feb;21:41-53. doi: 10.1016/j.math.2015.09.013. Epub 2015 Oct 3.'}, {'pmid': '16778675', 'type': 'BACKGROUND', 'citation': 'Mousavi SJ, Parnianpour M, Mehdian H, Montazeri A, Mobini B. The Oswestry Disability Index, the Roland-Morris Disability Questionnaire, and the Quebec Back Pain Disability Scale: translation and validation studies of the Iranian versions. Spine (Phila Pa 1976). 2006 Jun 15;31(14):E454-9. doi: 10.1097/01.brs.0000222141.61424.f7.'}, {'pmid': '25667932', 'type': 'BACKGROUND', 'citation': 'Noor NM, Aziz AA, Mostapa MR, Awang Z. Validation of the Malay version of the Inventory of Functional Status after Childbirth questionnaire. Biomed Res Int. 2015;2015:972728. doi: 10.1155/2015/972728. Epub 2015 Jan 15.'}, {'pmid': '21856077', 'type': 'BACKGROUND', 'citation': 'Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.'}, {'pmid': '32316686', 'type': 'BACKGROUND', 'citation': 'Navarro-Brazalez B, Prieto-Gomez V, Prieto-Merino D, Sanchez-Sanchez B, McLean L, Torres-Lacomba M. Effectiveness of Hypopressive Exercises in Women with Pelvic Floor Dysfunction: A Randomised Controlled Trial. J Clin Med. 2020 Apr 17;9(4):1149. doi: 10.3390/jcm9041149.'}]}, 'descriptionModule': {'briefSummary': 'The aim of study is to compare the effect of Hypopressive breathing and noble technique on width of Diastasis Recti Abdominis, lumbopelvic pain and maternal functioning in postpartum women.', 'detailedDescription': 'Candido shows that Caesarean section increased the likelihood of experiencing an increase in the inter-rectus distance during the postpartum period. Diastasis recti abdominis (DRA) is a common condition in postpartum women that can cause abdominal muscle separation. However, there is a lack of direct comparison between these two techniques. This study aims to compare the effectiveness of the hypopressive breathing and the Noble Technique in improving DRA in postpartum women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '24 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiparous women\n* History of Cesarean section and vaginal delivery\n* \\> 12 weeks postpartum\n* Measurement is 2cm or more then 2cm of DRA is included by using finger width palpation and Nylon digital caliper\n* Lumbopelvic pain (NPRS 3 to 8)\n\nExclusion Criteria:\n\n* Exclude women who need surgical correction for DRA\n* Pelvic organ prolapse\n* Para umbilical hernia\n* Malignancy\n* Bone tuberculosis\n* Fibromyalgia'}, 'identificationModule': {'nctId': 'NCT05916833', 'briefTitle': 'Comparison of Hypopressive Breathing and Noble Technique on DRA in Postpartum Women.', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Comparison of Hypopressive Breathing and Noble Technique on Diastasis Recti Abdominis in Postpartum Women.', 'orgStudyIdInfo': {'id': 'REC/01536 Saima Awan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hypopressive breathing technique', 'description': 'These exercises involved "sucking in the abdomen" and opening the ribs by engaging the accessory inspiratory muscles, such as the serratus anterior, external intercostalis, scalenes, and sternocleidomastoid, while maintaining the glottis closed, a process known as "diaphragmatic suction.', 'interventionNames': ['Other: hypopressive breathing']}, {'type': 'EXPERIMENTAL', 'label': 'noble technique', 'description': 'The Noble technique is (partially sitting up while manually flexing the rectus Abdominis muscles.', 'interventionNames': ['Other: noble technique']}], 'interventions': [{'name': 'hypopressive breathing', 'type': 'OTHER', 'description': 'Hot pack for 10min.Hypopressive breathing in sitting, lying and standing position. Hypopressive breathing 2 times/weekly, 5sec hold, 2-3reps, 1-2sets for 12 weeks. Session will be weekly progress.', 'armGroupLabels': ['hypopressive breathing technique']}, {'name': 'noble technique', 'type': 'OTHER', 'description': 'Hot pack for 10min. Noble technique in relaxed supine position 2time/weekly, 3-5sec hold, 10-15reps, 2-3sets for 12 weeks. Session will be weekly progress.', 'armGroupLabels': ['noble technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': "Maryam's Clinic", 'geoPoint': {'lat': 29.7426, 'lon': 73.14353}}], 'overallOfficials': [{'name': 'summra andleeb, MS(OMPT)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'riphah internation university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}