Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 1:48 PM
Study NCT ID:
NCT05231057
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2022-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Pilates Exercise in Children With Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026241', 'term': 'Exercise Movement Techniques'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-26', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessment', 'timeFrame': 'at baseline', 'description': 'measured using visual analog scale. A score of zero means no pain, while a score often means significant pain.'}, {'measure': 'Pain assessment', 'timeFrame': 'after 12 weeks', 'description': 'measured using visual analog scale. A score of zero means no pain, while a score often means significant pain.'}, {'measure': 'Cardiorespiratory fitness assessment', 'timeFrame': 'at baseline', 'description': 'assessed using electromagnetic cycle ergometer with electronic braking'}, {'measure': 'Cardiorespiratory fitness assessment', 'timeFrame': 'after 12 weeks', 'description': 'assessed using electromagnetic cycle ergometer with electronic braking'}], 'secondaryOutcomes': [{'measure': 'Functional ability assessment', 'timeFrame': 'at baseline', 'description': 'assessed using The Childhood Health Assessment Questionnaire'}, {'measure': 'Functional ability assessment', 'timeFrame': 'after 12 weeks', 'description': 'assessed using The Childhood Health Assessment Questionnaire'}, {'measure': 'health-related quality of life', 'timeFrame': 'at baseline', 'description': 'assessed using The self-report Pediatric Quality of Life Inventory'}, {'measure': 'health-related quality of life', 'timeFrame': 'after 12 weeks', 'description': 'assessed using The self-report Pediatric Quality of Life Inventory'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Juvenile Arthritis', 'Cardiorespiratory Fitness', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '25410840', 'type': 'BACKGROUND', 'citation': 'Franco CB, Ribeiro AF, Morcillo AM, Zambon MP, Almeida MB, Rozov T. Air stacking: effects of Pilates mat exercises on muscle strength and on pulmonary function in patients with cystic fibrosis. J Bras Pneumol. 2014 Oct;40(5):521-7. doi: 10.1590/s1806-37132014000500008.'}, {'pmid': '20391508', 'type': 'RESULT', 'citation': 'Oen K, Duffy CM, Tse SM, Ramsey S, Ellsworth J, Chedeville G, Chetaille AL, Saint-Cyr C, Cabral DA, Spiegel LR, Schneider R, Lang B, Huber AM, Dancey P, Silverman E, Rosenberg AM, Cameron B, Johnson N, Dorval J, Scuccimarri R, Campillo S, Petty RE, Duffy KN, Boire G, Haddad E, Houghton K, Laxer R, Turvey SE, Miettunen P, Gross K, Guzman J, Benseler S, Feldman BM, Espinosa V, Yeung RS, Tucker L. Early outcomes and improvement of patients with juvenile idiopathic arthritis enrolled in a Canadian multicenter inception cohort. Arthritis Care Res (Hoboken). 2010 Apr;62(4):527-36. doi: 10.1002/acr.20044.'}, {'pmid': '22238240', 'type': 'RESULT', 'citation': 'Haverman L, Grootenhuis MA, van den Berg JM, van Veenendaal M, Dolman KM, Swart JF, Kuijpers TW, van Rossum MA. Predictors of health-related quality of life in children and adolescents with juvenile idiopathic arthritis: results from a Web-based survey. Arthritis Care Res (Hoboken). 2012 May;64(5):694-703. doi: 10.1002/acr.21609.'}]}, 'descriptionModule': {'briefSummary': 'Juvenile idiopathic arthritis (JIA) is one of the most common chronic childhood inflammatory diseases that is characterized by permanent joint inflammation attributable to immune system disturbance.', 'detailedDescription': 'Therapeutic exercises play an essential role as a non-pharmacologic treatment for children with JIA. It has effectively been used to reduce pain, improve muscular function, increase physical activity and promote quality of life in children with chronic musculoskeletal disorders. Clinical Pilates exercise is usually perceived as enjoyable activity by children with JIA, thereby, it can help them be more active for extended periods without causing discomfort while also allowing them to control their breathing and avoid becoming fatigued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Polyarticular JIA per the International League of Associations for Rheumatology classification.\n* Age ranges from 10 to14 years.\n* Stable medical treatment.\n\nExclusion Criteria:\n\n* If they had contractures.\n* Congenital anomalies.\n* History of surgery.\n* History of systemic disease\n* Cardiorespiratory co-morbidity.\n* Participation in regular exercises or sports activity.'}, 'identificationModule': {'nctId': 'NCT05231057', 'acronym': 'Arthritis', 'briefTitle': 'Impact of Pilates Exercise in Children With Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Qassim University'}, 'officialTitle': 'Impact of Clinical Pilates Exercise on Pain, Cardiorespiratory Fitness, Functional Ability, And Quality of Life in Children With Polyarticular Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': 'RHPT/0020/0035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'Patients in the study group received Pilates exercises plus conventional physical therapy program', 'interventionNames': ['Other: Pilates exercises', 'Other: Conventional physical therapy program']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'Patients in the control group received conventional physical therapy', 'interventionNames': ['Other: Conventional physical therapy program']}], 'interventions': [{'name': 'Pilates exercises', 'type': 'OTHER', 'otherNames': ['Pilates band'], 'description': "Mat, Pilates band or elastic bands, and Pilate's ball", 'armGroupLabels': ['experimental group']}, {'name': 'Conventional physical therapy program', 'type': 'OTHER', 'otherNames': ['pain reliving modalities, stretching exercises'], 'description': 'pain relief, increasing flexibility, and mobility, improving muscle strength', 'armGroupLabels': ['control group', 'experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Al Kharj', 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University', 'geoPoint': {'lat': 24.15541, 'lon': 47.33457}}], 'overallOfficials': [{'name': 'Alshimaa Azab, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Maged Basha, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qassim University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.', 'accessCriteria': 'relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qassim University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}, {'name': 'Prince Sattam Bin Abdulaziz University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt.', 'investigatorFullName': 'Maged Basha', 'investigatorAffiliation': 'Qassim University'}}}}