Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-02-11 @ 6:54 PM
Study NCT ID:
NCT02063750
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strengthening Exercises 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': ['PHASE4'], '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': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-13', 'studyFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2014-02-13', 'lastUpdatePostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Pain - VAS', 'timeFrame': 'Basline, after 6 and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in quality of life - Fibromyalgia Impact Questionnaire (FIQ) questionnaire', 'timeFrame': 'Baseline, after 6 and 12 weeks'}, {'measure': 'Changes in muscle strength using the maximum repetition (1 RM)', 'timeFrame': 'Baseline, after 6 and 12 weeks'}, {'measure': 'Changes in consumption of analgesics', 'timeFrame': 'After 6 and 12 weeks from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Muscle strength exercises', 'Pain', 'Quality of life'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in patients with fibromyalgia (FM).\n\nMaterial and Method: Sixty FM patients were randomized into two groups: an intervention group (IG), in which patients performed muscle strength exercises using the Swiss ball, and a stretching group (SG), in which patients performed stretching exercises. All patients participated in 40-minute training sessions three times per week for 12 weeks. The IG performed the following eight strengthening exercises using a Swiss ball: lateral rise, simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell row, reverse crucifix and crucifix. The SG performed exercises targeting the same muscle groups trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for pain, 1 repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ) to evaluate disease impact, and short form health survey (SF-36) to assess quality of life. All participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of training. The assessor was blind to patient allocation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female with fibromyalgia according to the classification criteria of the American College of Rheumatology;\n* aged between 20 and 65 years old.\n\nExclusion Criteria:\n\n* uncontrolled hypertension;\n* decompensated cardiac disease;\n* history of syncope or exercise-induced arrhythmias and decompensated diabetes;\n* severe psychiatric illness;\n* history of regular exercise at least twice a week for the last 6 months;\n* any other condition that could prevent the patient from performing physical exercises.'}, 'identificationModule': {'nctId': 'NCT02063750', 'briefTitle': 'Strengthening Exercises for Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effectiveness of Strengthening Exercises Using the Swiss Ball for Patients With Fibromyalgia: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEP/UNIFESP - 1785/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strengthening group', 'description': 'This group perform muscle strengthening exercises using a Swiss ball of 65 cm diameter.', 'interventionNames': ['Other: strengthening exercises using a Swiss ball']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stretching group', 'description': 'Performed stretching exercises', 'interventionNames': ['Other: strengthening exercises']}], 'interventions': [{'name': 'strengthening exercises using a Swiss ball', 'type': 'OTHER', 'description': 'This group performed eight muscle strengthening exercises using a Swiss ball of 65 cm diameter and dumbbells with different loads.\n\nEach training session was 40 minutes long and was performed three times a week for 12 weeks. The exercises were performed in three sets of 12 repetitions, with an interval of one to two minutes of recovery between exercises, which alternated between upper limbs, lower limbs and abdomen. The load used was 60 % of one repetition maximum (1RM).', 'armGroupLabels': ['Strengthening group']}, {'name': 'strengthening exercises', 'type': 'OTHER', 'description': 'The stretching group performed stretching exercises that targeted the same muscles trained in the IG. The participants remained in the stretched position for three sets of 30 s for each exercise. The total session time was 40 minutes.', 'armGroupLabels': ['Stretching group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04023-090', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Federal de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Rheumatology Division', 'investigatorFullName': 'Jamil Natour', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}