Effects of Swimming in the Treatment of Fibromyalgia (ESTF)
| Tracking Information | |||||
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| First Received Date ICMJE | February 21, 2012 | ||||
| Last Updated Date | March 28, 2012 | ||||
| Start Date ICMJE | January 2012 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Diminishing of pain [ Time Frame: 3 months ] [ Designated as safety issue: No ] _ Assess the effectiveness of the practice of swimming in reducing pain and improving quality of life in patients with FM. |
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| Original Primary Outcome Measures ICMJE |
Diminshing of pain [ Time Frame: 3 months ] [ Designated as safety issue: No ] _ Assess the effectiveness of the practice of swimming in reducing pain and improving quality of life in patients with FM. |
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| Change History | Complete list of historical versions of study NCT01547195 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Improving quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ] _ Assess the effectiveness of the practice of swimming in improved function and aerobic capacity in patients with FM. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Swimming in the Treatment of Fibromyalgia | ||||
| Official Title ICMJE | Assessment of the Effects of Swimming in the Treatment of Patients With Fibromyalgia. | ||||
| Brief Summary | 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. Randomized controlled trial with blinded evaluator, which will be evaluated patients with fibromyalgia were divided into two groups. The intervention group will hold an exercise program of swimming (freestyle) and the other considered the control group held a walking program. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Fibromyalgia | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 75 | ||||
| Estimated Completion Date | December 2012 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Gender | Female | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01547195 | ||||
| Other Study ID Numbers ICMJE | 0360/10 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Giovana Fernandes, Federal University of São Paulo | ||||
| Study Sponsor ICMJE | Federal University of São Paulo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Federal University of São Paulo | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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