Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 2:29 AM
Study NCT ID:
NCT07076433
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Efficacy of Core Stability Exercises and Pilates in Fibromyalgia Management: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain by Quantitative Sensory Testing', 'timeFrame': '6 weeks', 'description': '10 the best results'}, {'measure': 'Functional Status: Fibromyalgia Impact Questionnaire (FIQ)', 'timeFrame': '6 weeks', 'description': '100 score tha best results'}], 'secondaryOutcomes': [{'measure': 'Balance and Posture: Force Plate Balance Testing', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Core Stability Exercises', 'Pilates', 'Fibromyalgia', 'functional assessment'], 'conditions': ['Fibromyositis-Fibromyalgia Syndrome']}, 'descriptionModule': {'briefSummary': 'Pilates and core stability exercises have emerged as potential interventions for Fibromyalgia (FM) , both targeting muscle strength, flexibility, and posture. However, existing studies have primarily relied on subjective self-report measures to assess outcomes. This study aims to employ more objective assessments, including biomechanical and functional measures, to compare the efficacy of core stability exercises and Pilates in improving symptoms of FM.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female participants aged 35-65 years\n* Diagnosed with fibromyalgia based on the American College of Rheumatology (ACR) 2010 criteria\n* Able to walk independently\n* Stable medication for at least 3 months prior to participation\n\nExclusion Criteria:\n\n* Pregnant women\n* History of significant orthopedic, cardiopulmonary, or neurological conditions\n* Severe psychiatric disorders that interfere with participation\n* Active substance abuse'}, 'identificationModule': {'nctId': 'NCT07076433', 'briefTitle': 'Comparing the Efficacy of Core Stability Exercises and Pilates in Fibromyalgia Management: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Al-Zaytoonah University of Jordan'}, 'officialTitle': 'Comparing the Efficacy of Core Stability Exercises and Pilates in Fibromyalgia Management: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'fibromyalgia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Core Stability Exercises', 'description': 'Participants will engage in core stability exercises targeting the muscles of the trunk and pelvis, such as pelvic tilting, abdominal crunches, back extension, side bridges, and bird dog. These exercises will be performed twice a week for 6 weeks, with each session lasting 30 minutes. The intensity will be progressively increased based on individual tolerance.', 'interventionNames': ['Other: Core Stability Exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Pilates:', 'description': '\\- Participants will undergo Pilates sessions that emphasize flexibility, posture, and core engagement. Pilates exercises will be performed twice a week for 6 weeks, with each session lasting 30 minutes. The focus will be on breathing, spinal alignment, and strengthening exercises that challenge flexibility and balance.', 'interventionNames': ['Other: Pilates:']}], 'interventions': [{'name': 'Core Stability Exercises', 'type': 'OTHER', 'description': 'Participants will engage in core stability exercises targeting the muscles of the trunk and pelvis, such as pelvic tilting, abdominal crunches, back extension, side bridges, and bird dog. These exercises will be performed twice a week for 6 weeks, with each session lasting 30 minutes. The intensity will be progressively increased based on individual tolerance.', 'armGroupLabels': ['Core Stability Exercises']}, {'name': 'Pilates:', 'type': 'OTHER', 'description': 'Participants will undergo Pilates sessions that emphasize flexibility, posture, and core engagement. Pilates exercises will be performed twice a week for 6 weeks, with each session lasting 30 minutes. The focus will be on breathing, spinal alignment, and strengthening exercises that challenge flexibility and balance.', 'armGroupLabels': ['Pilates:']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amman', 'country': 'Jordan', 'facility': 'Al Zaytoonah University', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Zaytoonah University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor hanan hosny M Battesha', 'investigatorFullName': 'Hanan Hosny M Battesha', 'investigatorAffiliation': 'Al-Zaytoonah University of Jordan'}}}}