Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
Study NCT ID:
NCT06556992
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2024-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fitness Integrative Training for Pediatric Rheumatology Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D007593', 'term': 'Joint Instability'}, {'id': 'D003882', 'term': 'Dermatomyositis'}], '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'}, {'id': 'D017285', 'term': 'Polymyositis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm behavioral intervention feasibility trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Enrollment', 'timeFrame': '2 years', 'description': 'Maintain consistent monthly enrollment for the duration of the project'}, {'measure': 'Session Attendance', 'timeFrame': '8 weeks', 'description': 'Evaluation of the number of sessions attended out of the 16 sessions offered'}, {'measure': 'Participant Retention at Post-Treatment', 'timeFrame': '8 weeks', 'description': 'Number of participants completing post-treatment visit'}, {'measure': 'Treatment Fidelity', 'timeFrame': '2 years', 'description': 'All sessions will be video-recorded and trainers adherence to the protocol will be assessed using an 9-item fidelity checklist (e.g., homework and diary review, CBT skill instruction and practice, neuromuscular exercise instruction and practice, CBT and exercise homework planning).'}, {'measure': 'Participant Safety', 'timeFrame': '2 years', 'description': 'Assessment of frequency and severity of adverse events possibly, likely, or definitely related to the study treatment or procedures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis', 'Systemic Lupus Erythematosus of Childhood', 'Joint Hypermobility', 'Juvenile Dermatomyositis']}, 'descriptionModule': {'briefSummary': 'This study evaluates the feasibility of the Fitness Integrative Training program for Teens (FIT Teens 2), a combined cognitive behavioral therapy and neuromuscular exercise training program in patients with pediatric rheumatic diseases and/or joint hypermobility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric rheumatic diseases (PRD) or joint hypermobility (JH) diagnosed by a pediatric rheumatologist or pain physician.\n* Initial diagnosis ≥ 3 months ago\n* Ages 10-19 years, inclusive\n* Ongoing symptoms of musculoskeletal pain and/or fatigue for at least 3 months\n* Functional Disability Index (FDI) Score ≥ 13 indicating at least moderate disability.\n* Child has written and spoken proficiency in English and parent has written and spoken proficiency in English or Spanish (will have a certified bilingual provider or interpreter available)\n\nExclusion Criteria:\n\n* Untreated major psychiatric diagnoses (e.g., major depression, bipolar disorder, psychoses) or documented developmental delay.\n* Any other medical condition determined by their physician to be a contraindication for exercise.\n* Childhood Myositis Assessment Scale (CMAS) ≤ 30'}, 'identificationModule': {'nctId': 'NCT06556992', 'acronym': 'FIT Teens 2', 'briefTitle': 'Fitness Integrative Training for Pediatric Rheumatology Disorders', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Fitness Integrative Training for Pediatric Rheumatology Disorders (FIT Teens II): a Pilot Feasibility Study', 'orgStudyIdInfo': {'id': 'CIN002FIT-Teens2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FIT Teens', 'description': 'Fitness Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance.', 'interventionNames': ['Behavioral: FIT Teens']}], 'interventions': [{'name': 'FIT Teens', 'type': 'BEHAVIORAL', 'description': 'This intervention will consist of 16 in-person and remote group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.', 'armGroupLabels': ['FIT Teens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Susmita Kashikar-Zuck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}