Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-01-01 @ 8:42 PM
Study NCT ID:
NCT01547195
Status:
UNKNOWN
Last Update Posted:
2012-03-30
First Post:
2012-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Swimming in the Treatment of Fibromyalgia
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': 'D013550', 'term': 'Swimming'}, {'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-28', 'studyFirstSubmitDate': '2012-02-21', 'studyFirstSubmitQcDate': '2012-03-03', 'lastUpdatePostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diminishing of pain', 'timeFrame': '3 months', 'description': '\\_ Assess the effectiveness of the practice of swimming in reducing pain and improving quality of life in patients with FM.'}], 'secondaryOutcomes': [{'measure': 'Improving quality of life', 'timeFrame': '3 months', 'description': '\\_ Assess the effectiveness of the practice of swimming in improved function and aerobic capacity in patients with FM.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fibromyalgia', 'swimming'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '26903145', 'type': 'DERIVED', 'citation': 'Fernandes G, Jennings F, Nery Cabral MV, Pirozzi Buosi AL, Natour J. Swimming Improves Pain and Functional Capacity of Patients With Fibromyalgia: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1269-75. doi: 10.1016/j.apmr.2016.01.026. Epub 2016 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The recent scientific evidence shows that FM patients improve exercise capacity, symptoms and quality of life with the holding of regular exercise, especially aerobic exercise. Swimming is an aerobic workout of low impact, but no study has evaluated the effect of this activity in patients with fibromyalgia.\n\nRandomized controlled trial with blinded evaluator, which will be evaluated patients with fibromyalgia were divided into two groups.\n\nThe intervention group will hold an exercise program of swimming (freestyle) and the other considered the control group held a walking program.', 'detailedDescription': 'Fibromyalgia (FM) is a syndrome characterized by diffuse musculoskeletal pain and chronic, with points called "hot spots", specific, sensitive and painful on palpation. Objective: To evaluate the efficacy of swimming in reducing the generally pain and improve the quality of function, of life and exercise capacity in patients with fibromyalgia. Material and Methods: 82 patients will be screened, diagnosed with fibromyalgia, who can swim the front crawl. Will be selected at UNIFESP outpatient clinics and also through advertisement in a newspaper. One group held the swimming training and the other group (control) will walk training. The Participants perform exercises (swimming or running) three times a week for 50 minutes, for 12 weeks. The exercises will be held at the anaerobic threshold determined by cardiopulmonary exercise testing. Measuring instrument: Questionnaires VAS (visual analogue scale) for pain, FIQ (Fibromyalgia Impact Questionnaire) to assess the quality of life related to disease, and also the SF-36 (short form health survey), which assesses quality of life in general. Cardiopulmonary stress test to assess cardiorespiratory fitness to sit and stand up and test to assess functional capacity. All participants will conduct an initial evaluation, after 6 and 13 weeks of training.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Female patients with fibromyalgia according to the classification criteria of the American College of Rheumatology;\n* Patients with degree of pain between 4 and 8 cm by VAS-visual analog scale;\n* Patients who can swim the freestyle "(crawl)"; Patients with stable-medication for at least three months;\n* All patients will have signing the consent form.\n\nEXCLUSION CRITERIA:\n\n* Patients with uncontrolled cardiac disease and / or unable to perform aerobic exercises;\n* Patients with severe psychiatric disorders;\n* Patients with uncontrolled diabetes mellitus;\n* Patients who practice regular physical exercise for at least 3 months;\n* Patients with skin diseases that contraindicate the use of swimming pool;\n* Patients with inflammatory rheumatic diseases.'}, 'identificationModule': {'nctId': 'NCT01547195', 'acronym': 'ESTF', 'briefTitle': 'Effects of Swimming in the Treatment of Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Assessment of the Effects of Swimming in the Treatment of Patients With Fibromyalgia.', 'orgStudyIdInfo': {'id': '0360/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group-swimming', 'interventionNames': ['Procedure: swim training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control-walk', 'interventionNames': ['Procedure: Training walk']}], 'interventions': [{'name': 'swim training', 'type': 'PROCEDURE', 'otherNames': ['Swimming.', 'Freestyle.'], 'description': 'Swimming training will be conducted with the implementation of the freestyle. The training will be held a week with 3 X 50 minutes for a period of 12 weeks.\n\nPatients will be monitored by a frequency waterproof. When at the beginning of training are carried out five minutes of heating, followed by 40minutos swimming 5 minutes and cooling at the end of training.', 'armGroupLabels': ['Group-swimming']}, {'name': 'Training walk', 'type': 'PROCEDURE', 'otherNames': ['Walk.'], 'description': 'The control group will perform walking exercise outdoors, monitored by a frequency, with the heart rate at anaerobic threshold assessed by cardiopulmonary exercise test.\n\nThe training of walking will last 50 minutes, three times per week for 12 weeks.\n\nAt the beginning of training, there will be a heating time of 5 minutes, followed by LA walk in cooling for 40 minutes and 5 minutes.', 'armGroupLabels': ['Control-walk']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Giovana Fernandes, Master', 'role': 'CONTACT', 'email': 'gifernandespersonal@hotmail.com', 'phone': '+55 11 84987581'}, {'name': 'Giovana Fernandes, Mestranda', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ambulatory at UNIFESP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Jamil Natour, Professor', 'role': 'CONTACT', 'email': 'jnatour@unifesp.com.br', 'phone': '+55 11 55764239'}, {'name': 'Giovana Fernandes, Mestranda', 'role': 'CONTACT', 'phone': '+55 11 25943375'}, {'name': 'Jamil Natour, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universidade Federal de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Giovana Fernandes, Mestranda', 'role': 'CONTACT', 'email': 'gifernandespersonal@hotmail.com', 'phone': '+55 11 25943375'}], 'overallOfficials': [{'name': 'Giovana Fernandes, Mestranda', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal de São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'EVALUATION OF THE EFFECTS OF SWIMMING IN THE TREATMENT OF PATIENTS WITH FIBROMYALGIA', 'investigatorFullName': 'Giovana Fernandes', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}