Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-08 @ 4:49 AM
Study NCT ID:
NCT03286933
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2017-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-15', 'studyFirstSubmitDate': '2017-09-14', 'studyFirstSubmitQcDate': '2017-09-15', 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peds QL-Arthritis Module 4.0', 'timeFrame': '8 weeks', 'description': 'Measures perceived quality of life for adolescents with arthritis'}, {'measure': 'Visual Analog Pain Scale', 'timeFrame': '8 weeks', 'description': 'Visual marker of perceived pain'}, {'measure': 'Visual Assessment', 'timeFrame': '8 weeks', 'description': 'Physician visual assessment'}, {'measure': 'Joint Damage Assessment (JADI)', 'timeFrame': '8 weeks', 'description': 'assessment of joints'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['yoga therapy', 'JIA', 'quality of life', 'pain management'], 'conditions': ['Adolescent Juvenile Idiopathic Arthritis', 'Yoga Therapy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to better understand the effects of a yoga program on adolescents with juvenile idiopathic arthritis (JIA). The investigators want to learn whether or not a yoga therapy based program will decrease pain and improve quality of life in patients with JIA.\n\nThis is an 8-week program with home program of online videos.', 'detailedDescription': 'This is an 8-week program consisting of weekly yoga therapy classes in a public studio. The classes are led by a pediatric occupational therapist who is also a certified internationally accredited yoga therapist (C-IAYT). The initial and final sessions will include an Rheumatologist MD evaluation including a physician global assessment and joint damage assessment (JADI) and visual assessment (VAS). A Visual Analog Pain Scale will and Peds Quality of Life Questionnaire-Arthritis Module 4.0 will be administered. Each yoga class is 75 minutes to include a set-sequence of postures including breathing exercises and final corpse pose (final relaxation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents with formal diagnosis of JIA, speak and understand English, can get on/off floor independently.\n\nExclusion Criteria:\n\n* Dependent on assistive device for ambulation; does not understand English, does not have a diagnosis of JIA.'}, 'identificationModule': {'nctId': 'NCT03286933', 'briefTitle': 'Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': 'CHLA-17-00037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga therapy intervention', 'description': 'Participants will participate in weekly yoga therapy sessions and have the opportunity to use the home video online.', 'interventionNames': ['Behavioral: yoga']}], 'interventions': [{'name': 'yoga', 'type': 'BEHAVIORAL', 'description': '75 minute weekly group yoga classes for 8 weeks. Home program online.', 'armGroupLabels': ['Yoga therapy intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participants will be coded and all data will be connected to their code. No names will be used after recruitment.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adina Schwartz, MA, OTR/L, Principal Investigator', 'investigatorFullName': 'Adina', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}