Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-28 @ 2:50 AM
Study NCT ID:
NCT03731520
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2018-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2018-11-03', 'studyFirstSubmitQcDate': '2018-11-03', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '11-point Numeric Analogue Scale', 'timeFrame': 'baseline'}, {'measure': 'Exercise Stages of Change Scale-Short Form', 'timeFrame': 'baseline'}, {'measure': 'Exercise Self-Efficacy Scale', 'timeFrame': 'baseline'}, {'measure': 'Decisional Balance Scale', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Juvenile Idiopathic Arthritis', 'exercise', 'behavior'], 'conditions': ['Juvenile Idiopathic Arthritis']}, 'descriptionModule': {'briefSummary': 'Juvenile idiopathic arthritis (JIA) is one of the most common rheumatic diseases in childhood, affecting at least 1 in 1000 children. Children with JIA experience joint inflammation and swelling, pain and tenderness, morning stiffness, limited mobility. Children with JIA complain pain and have lower functional ability and decreased quality of life compared with their peers. Many studies have reported that patients with JIA have low physical activity levels and also exercise therapy is considered an important component of the treatment of JIA. Nowadays, studies for evaluating exercise behaviours in order to cope with physical inactivity for many chronic diseases are becoming increasingly important.The objective of this study is to determine exercise behaviour in patients with JIA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed as JIA according to ILAR classification\n* Aged between 6-18\n* Adequate cognitive function for understanding questions\n\nExclusion Criteria:\n\n\\- a parent who does not have a smartphone'}, 'identificationModule': {'nctId': 'NCT03731520', 'briefTitle': 'Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': 'IstanbulUC2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Assessing exercise behavior', 'description': 'determining exercise behaviour in patients with JIA by using specific scales', 'interventionNames': ['Diagnostic Test: Assessing exercise behavior']}], 'interventions': [{'name': 'Assessing exercise behavior', 'type': 'DIAGNOSTIC_TEST', 'description': '11-point Numeric Analogue Scale (NRS) for satisfaction of exercising, Exercise Stages of Change Scale-Short Form (ESCS), Exercise Self-Efficacy Scale (ESES), and Decisional Balance Scale (DBS) for exercise behaviour will be inquired for the patients with JIA.', 'armGroupLabels': ['Assessing exercise behavior']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34740', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saime Nilay Arman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assist.Prof.', 'investigatorFullName': 'Saime Nilay Arman', 'investigatorAffiliation': 'Istanbul University'}}}}