Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-28 @ 2:10 PM
Study NCT ID:
NCT03588208
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2018-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progressive Resistance Training for Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2018-07-04', 'studyFirstSubmitQcDate': '2018-07-04', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': 'Baseline and after 6 and 12 weeks', 'description': 'Measured by numerical pain scale'}], 'secondaryOutcomes': [{'measure': 'Change in Health related quality of life', 'timeFrame': 'Baseline and after 6 and 12 weeks', 'description': 'Measured by Fibromyalgia Impact Questionnaire'}, {'measure': 'Change in Generic quality of life', 'timeFrame': 'Baseline and after 6 and 12 weeks', 'description': 'Measured by the Medical Outcome Survey Short Form 36'}, {'measure': 'Change in Functional capacity', 'timeFrame': 'Baseline and after 6 and 12 weeks', 'description': 'Measured by the 6-minute Walk Test'}, {'measure': 'Change in strength', 'timeFrame': 'Baseline and after 6 and 12 weeks', 'description': 'Measured by the 1 repetition maximum'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Pain', 'Function', 'Quality of life'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'Patients in the experimental group underwent a progressive resistance training program, performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training, the experimental group also conducted a structured education program in one hour class once a week for five weeks. Patients in the control group performed the same education program.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology;\n* Feminine gender;\n* Age between 18 and 65 years;\n* Pain between 3 and 8 cm in the Numerical Pain Scale (END);\n* Have not changed treatment for fibromyalgia in the past three months;\n* Agree to participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Cognitive deficit that does not allow the understanding of the evaluation instruments;\n* Other diseases that make it impossible to perform the exercises;\n* Physical activity started or changed in the last three months;\n* Physical therapy in the last six months;\n* In litigation.'}, 'identificationModule': {'nctId': 'NCT03588208', 'briefTitle': 'Progressive Resistance Training for Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Evaluation of the Effectiveness of a Progressive Resistance Training Program for Patients With Fibromyalgia: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEP UNIFESP 482056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'interventionNames': ['Other: Progressive resistance training program', 'Other: Educational Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Other: Educational Program']}], 'interventions': [{'name': 'Progressive resistance training program', 'type': 'OTHER', 'description': 'Progressive resistance training program were performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Educational Program', 'type': 'OTHER', 'description': 'Structured education program were performed during one hour class once a week for five weeks', 'armGroupLabels': ['Control Group', 'Intervention Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anamaria Jones', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}