Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 2:29 AM
Study NCT ID:
NCT05439668
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2022-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Abdominal Exercise Programs on the Interrect Distance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2022-06-17', 'studyFirstSubmitQcDate': '2022-06-26', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interrectus distance measure', 'timeFrame': 'Baseline, preintervention', 'description': 'he participants will be placed in supine decubitus with the knees flexed to 90º with the feet resting on the stretcher and the arms along the body. After receiving the instructions to perform an abdominal crunch, subjects are asked to lift their heads and lift shoulders until the scapula lifts off the table. The ultrasound images will be recorded with an ultrasound scanner (GE Logic and; 4 12MHz, 39mm linear transducer; mode B), in a position of supine rest and a position of muscle activation (isometric contraction), 2 cm and 5 cm above the navel. Centimeters are the unit of measurement.'}, {'measure': 'Interrectus distance measure', 'timeFrame': 'After the intervention', 'description': 'he participants will be placed in supine decubitus with the knees flexed to 90º with the feet resting on the stretcher and the arms along the body. After receiving the instructions to perform an abdominal crunch, subjects are asked to lift their heads and lift shoulders until the scapula lifts off the table. The ultrasound images will be recorded with an ultrasound scanner (GE Logic and; 4 12MHz, 39mm linear transducer; mode B), in a position of supine rest and a position of muscle activation (isometric contraction), 2 cm and 5 cm above the navel. Centimeters are the unit of this measurement.'}], 'secondaryOutcomes': [{'measure': 'Maternal age', 'timeFrame': 'Preintervention', 'description': 'Age when the woman gave birth. This variable will be managed by the midwives through their clinical history. Years are the unit of this measurement.'}, {'measure': 'Fetal weight', 'timeFrame': 'Preintervenrion', 'description': 'Weight baby This variable will be managed by the midwives through their clinical history. Kilogrames are the unit of this measurement.'}, {'measure': 'Number of deliveries', 'timeFrame': 'Preintervention', 'description': 'Total of number of deliveries. This variable will be managed by the midwives through their clinical history. Absolut number are the unit of this measurement.'}, {'measure': 'Weight gain during pregnancy', 'timeFrame': 'Preintervention', 'description': 'Weight gain during pregnancy. This variable will be managed by the midwives through their clinical history. Kilogrames are the unit of this measurement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal muscle', 'Interrectus distance', 'Abdominal hypopressive exercise', 'Abdominal crunch exercise'], 'conditions': ['Postpartum Period']}, 'referencesModule': {'references': [{'pmid': '34356983', 'type': 'BACKGROUND', 'citation': 'Da Cuna-Carrera I, Alonso-Calvete A, Soto-Gonzalez M, Lantaron-Caeiro EM. How Do the Abdominal Muscles Change during Hypopressive Exercise? Medicina (Kaunas). 2021 Jul 9;57(7):702. doi: 10.3390/medicina57070702.'}, {'pmid': '31370947', 'type': 'BACKGROUND', 'citation': 'Carrera Perez C, Da Cuna Carrera I, Gonzalez Gonzalez Y. [What is the best exercise for rehabilitation of abdominal diastasis rehabilitation?]. Rehabilitacion (Madr). 2019 Jul-Sep;53(3):198-210. doi: 10.1016/j.rh.2018.12.004. Epub 2019 Apr 11. Spanish.'}, {'pmid': '34210004', 'type': 'BACKGROUND', 'citation': 'Da Cuna-Carrera I, Alonso-Calvete A, Lantaron-Caeiro EM, Soto-Gonzalez M. Are There Any Differences in Abdominal Activation between Women and Men during Hypopressive Exercises? Int J Environ Res Public Health. 2021 Jun 29;18(13):6984. doi: 10.3390/ijerph18136984.'}, {'pmid': '26304639', 'type': 'BACKGROUND', 'citation': 'Mota P, Pascoal AG, Carita AI, Bo K. The Immediate Effects on Inter-rectus Distance of Abdominal Crunch and Drawing-in Exercises During Pregnancy and the Postpartum Period. J Orthop Sports Phys Ther. 2015 Oct;45(10):781-8. doi: 10.2519/jospt.2015.5459. Epub 2015 Aug 24.'}, {'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': '39666696', 'type': 'DERIVED', 'citation': 'Soto-Gonzalez M, Da Cuna-Carrera I, Lantaron-Caeiro EM, Pascoal AG. Effect of hypopressive and conventional abdominal exercises on postpartum diastasis recti: A randomized controlled trial. PLoS One. 2024 Dec 12;19(12):e0314274. doi: 10.1371/journal.pone.0314274. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the research is to compare two programs of exercises in postpartum woman, one based in abdominal strengthening exercises and the other based in abdominal hypopresive exercise.', 'detailedDescription': 'Diastasis recti abdominisis the separation of the two rectus abdominis muscles along the linea alba with a consequent separation of fibres and widening of the same. The linea alba has different functions which include supporting the proximal anterior recti, guaranteeing the stability of the vertebral column, pelvis and the pelvic floor, and intervening in the function of the abdominal muscles since it serves as their anterior anchorage.\n\nThe crunch abdominal exercise (classic abdominal) is the most studied exercise used to test the behaviour of the linea alba, and in most cases, a decrease in the inter-rectus distance is observed when compared to the resting stage. In the oder hand, Abdominal hypopresives exercises were designed for women in the postpartum period but the effects over the abdominal muscles is unknown and the authors are unaware of any study that evaluates the effect of a hypopressive exercise program on the interrectus distance.\n\nThe objective of the research is to compare two programs of exercises in postpartum woman, one based in abdominal strengthening exercises and the other based in abdominal hypopresive exercise.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women having given birth 8 weeks before starting the study treatment\n* Women agree to participate in the study\n* Women with vaginal delivery.\n\nExclusion Criteria:\n\n* Women with abdominal hernia\n* Pregnancy woman\n* Previus Abdominal Surgery'}, 'identificationModule': {'nctId': 'NCT05439668', 'briefTitle': 'Comparison of Two Abdominal Exercise Programs on the Interrect Distance', 'organization': {'class': 'OTHER', 'fullName': 'University of Vigo'}, 'officialTitle': 'Comparison of Two Abdominal Exercise Programs on the Interrect Distance in Postpartum Woman', 'orgStudyIdInfo': {'id': '17062022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Classic abdominal exercises Group', 'description': 'This group will carry out an abdominal strengthening exercise program based on the classic abdominal exercises.', 'interventionNames': ['Other: Classic abdominal strengthening exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Abdominal hypopresives exercise Group', 'description': 'This group will carry out an abdominal strengthening exercise program based on the abdominal hypopressives exercises.', 'interventionNames': ['Other: Hypopressive abdominal exercises program']}], 'interventions': [{'name': 'Classic abdominal strengthening exercises', 'type': 'OTHER', 'description': 'Classic abdominal strengthening exercises (Curl-up, sit-ups and leg-rise), balance exercises, general mobility and upper limb strengthening exercises.', 'armGroupLabels': ['Classic abdominal exercises Group']}, {'name': 'Hypopressive abdominal exercises program', 'type': 'OTHER', 'description': 'Hypopressive abdominal exercises, balance exercises, general mobility and upper limb strengthening exercises', 'armGroupLabels': ['Abdominal hypopresives exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36005', 'city': 'Pontevedra', 'country': 'Spain', 'facility': 'Iria Da Cuña Carrera', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}], 'overallOfficials': [{'name': 'Iria Da Cuña-carrera, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitu of Vigo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vigo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Iria Da Cuña Carrera', 'investigatorAffiliation': 'University of Vigo'}}}}