Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-03-01 @ 6:01 AM
Study NCT ID:
NCT03651232
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2018-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Yoga for Pregnancy Related Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}, {'id': 'D012657', 'term': 'Self-Help Groups'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feasibility of recruitment', 'timeFrame': 'baseline', 'description': 'recruitment rate'}], 'secondaryOutcomes': [{'measure': 'back pain disability', 'timeFrame': 'baseline, 4, 8, 12 weeks', 'description': 'Roland Morris Disability Questionnaire (range 0-24), lower better'}, {'measure': 'back pain severity', 'timeFrame': 'baseline, 4, 8, 12 weeks', 'description': 'Back Pain Severity Visual Analogue Scale (rage 0-10), lower better'}, {'measure': 'pregnancy symptoms', 'timeFrame': 'baseline, 4, 8, 12 weeks', 'description': 'Pregnancy Symptom Inventory (range 0-123), lower better'}, {'measure': 'depression', 'timeFrame': 'baseline, 4, 8, 12 weeks', 'description': 'Edinburgh Postnatal Depression Scale (range 0-30), lower better'}, {'measure': 'quality of lfe', 'timeFrame': 'baseline, 4, 8, 12 weeks', 'description': 'Short Form-12 (range 12-56), higher better'}, {'measure': 'childbirth experience', 'timeFrame': 'postpartum visit', 'description': 'Childbirth Experience (range 19-76), higher better'}, {'measure': 'mobility lab- speed', 'timeFrame': 'baseline, 4, 8, 12 weeks', 'description': 'instrumented gait speed'}, {'measure': 'acceptability', 'timeFrame': '4,8, 12 weeks, postpartum', 'description': 'class attendance'}, {'measure': 'mobility lab- double support', 'timeFrame': 'baseline, 4, 8, 12 weeks', 'description': 'double support time'}, {'measure': 'mobility lab- TUG', 'timeFrame': 'baseline, 4, 8, 12 weeks', 'description': 'timed up and go time'}, {'measure': 'mobility lab- turn', 'timeFrame': 'baseline, 4, 8, 12 weeks', 'description': 'turn time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'This is a pilot feasibility study investigating prenatal yoga for pregnancy related back pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* uncomplicated pregnancies starting at 12-26 weeks of gestation\n* pregnant women with and without back pain who had no regular yoga practice.\n\nExclusion Criteria:\n\n* significant back pathology\n* pregnancy complications\n* non-English speaking\n* otherwise were not able to participate (eg. transportation, scheduling issues)'}, 'identificationModule': {'nctId': 'NCT03651232', 'briefTitle': 'Prenatal Yoga for Pregnancy Related Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Prenatal Yoga for Pregnancy Related Back Pain', 'orgStudyIdInfo': {'id': '2014P000344'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'yoga', 'description': 'weekly prenatal yoga group class', 'interventionNames': ['Behavioral: yoga']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'support', 'description': 'weekly group support class', 'interventionNames': ['Behavioral: support group']}], 'interventions': [{'name': 'yoga', 'type': 'BEHAVIORAL', 'description': 'once weekly group yoga class for 12 weeks', 'armGroupLabels': ['yoga']}, {'name': 'support group', 'type': 'BEHAVIORAL', 'description': 'once weekly group support class for 12 weeks', 'armGroupLabels': ['support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Gloria Yeh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine, Harvard Medical School', 'investigatorFullName': 'Gloria Y. Yeh', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}