Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:23 AM
Study NCT ID:
NCT07344857
Status:
COMPLETED
Last Update Posted:
2026-01-22
First Post:
2026-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Pilates and Postpartum Ligamentous Laxity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007593', 'term': 'Joint Instability'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2026-01-08', 'studyFirstSubmitQcDate': '2026-01-08', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ligament laxity', 'timeFrame': '10 minutes', 'description': 'The anterior tibial translation of the knee will be considered as representative of the anterior laxity of the knee of women measured with an arthrometer ® (bilateral examination repeated 3 times on each knee).The degree of laxity will be evaluated thanks to the international classification IKDC.'}], 'secondaryOutcomes': [{'measure': 'Generalized joint hypermobility', 'timeFrame': '2 minutes', 'description': 'Generalized joint hypermobility (GJH) was assessed using the Beighton scoring system, which consists of five bilateral and unilateral maneuvers. Each positive test scored one point, with a maximum score of 9. A score of ≥5 indicated GJH.'}, {'measure': 'Physical activity level', 'timeFrame': '7 days', 'description': "Participants' physical activity was monitored using the Omron HJ-321-E pedometer (Omron Healthcare, Japan), which detects vertical oscillations and stores up to seven days of data."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laxity of Ligament', 'Pregnancy', 'Pilates Exercise']}, 'descriptionModule': {'briefSummary': 'Pregnancy induces hormonal and biomechanical adaptations that increase ligamentous laxity, which may persist into the postpartum period and contribute to joint instability, pain, and functional limitations. Although prenatal Pilates has been shown to prevent the progression of ligamentous laxity during pregnancy, its effects on postpartum musculoskeletal recovery remain unclear. This longitudinal follow-up of a randomized controlled trial evaluated ligamentous recovery at 6 weeks postpartum in women who participated in a structured prenatal Pilates program continued until childbirth, compared with women receiving standard prenatal care. Postpartum ligamentous laxity, generalized joint hypermobility, and activity limitations related to pelvic girdle pain were assessed using objective and clinical measures. The study aimed to determine whether prenatal Pilates facilitates early postpartum ligamentous recovery and supports functional outcomes during the early postpartum period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of postpartum women aged 18-35 years who were 6th week after delivery and who voluntarily agreed to participate in the study. Women with known cardiovascular or pulmonary diseases, and those who had participated in structured physical activity programs prior to enrollment were excluded. These criteria were applied to ensure a homogeneous sample and to minimize potential confounding factors related to pre-existing health conditions or prior exercise exposure.', 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18-35 years\n* In the 6th week of post-partum\n* Voluntary participation in the study\n\nExclusion Criteria:\n\n* Cardiovascular or pulmonary diseases\n* Prior participation in structured physical activity programs'}, 'identificationModule': {'nctId': 'NCT07344857', 'briefTitle': 'Prenatal Pilates and Postpartum Ligamentous Laxity', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Medipol University'}, 'officialTitle': 'Impact of a Prenatal Pilates Program Continued Until Childbirth on Postpartum Ligamentous Recovery: a Longitudinal Follow-up of a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AnkaraMedipolU-FTR-2025-223'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pilates Group', 'description': 'Participants in the Pilates group attended supervised 60-minute sessions twice weekly for eight weeks, led by a certified physiotherapist trained by the Australian Institute of Pilates and Physiotherapy.'}, {'label': 'Control Group', 'description': 'The control group received standard prenatal care and ergonomic advice, and did not participate in any exercise training.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06050', 'city': 'Ankara', 'state': 'Altındağ', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Medipol University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Asst.', 'investigatorFullName': 'Selcan Suicmez', 'investigatorAffiliation': 'Ankara Medipol University'}}}}