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Effects of Swimming in the Treatment of Fibromyalgia (ESTF)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Giovana Fernandes, Federal University of São Paulo.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Federal University of São Paulo
Information provided by (Responsible Party):
Giovana Fernandes, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01547195
First received: February 21, 2012
Last updated: March 28, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Fibromyalgia | Procedure: swim training Procedure: Training walk | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Assessment of the Effects of Swimming in the Treatment of Patients With Fibromyalgia. |
Resource links provided by NLM:
Further study details as provided by Giovana Fernandes, Federal University of São Paulo:
Primary Outcome Measures:
- Diminishing of pain [ Time Frame: 3 months ]_ Assess the effectiveness of the practice of swimming in reducing pain and improving quality of life in patients with FM.
Secondary Outcome Measures:
- Improving quality of life [ Time Frame: 3 months ]_ Assess the effectiveness of the practice of swimming in improved function and aerobic capacity in patients with FM.
| Estimated Enrollment: | 75 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group-swimming |
Procedure: swim training
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. Patients 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. Other Names:
|
| Active Comparator: Control-walk |
Procedure: Training walk
The control group will perform walking exercise outdoors, monitored by a frequency, with the heart rate at anaerobic threshold assessed by cardiopulmonary exercise test. The training of walking will last 50 minutes, three times per week for 12 weeks. At 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. Other Name: Walk.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
INCLUSION CRITERIA:
- Female patients with fibromyalgia according to the classification criteria of the American College of Rheumatology;
- Patients with degree of pain between 4 and 8 cm by VAS-visual analog scale;
- Patients who can swim the freestyle "(crawl)"; Patients with stable-medication for at least three months;
- All patients will have signing the consent form.
EXCLUSION CRITERIA:
- Patients with uncontrolled cardiac disease and / or unable to perform aerobic exercises;
- Patients with severe psychiatric disorders;
- Patients with uncontrolled diabetes mellitus;
- Patients who practice regular physical exercise for at least 3 months;
- Patients with skin diseases that contraindicate the use of swimming pool;
- Patients with inflammatory rheumatic diseases.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01547195
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547195
Contacts
| Contact: Giovana Fernandes, Mestranda | +55 11 25943375 | gifernandespersonal@hotmail.com |
Locations
| Brazil | |
| Universidade Federal de São Paulo | Recruiting |
| São Paulo, SP, Brazil | |
| Contact: Jamil Natour, Professor +55 11 55764239 jnatour@unifesp.com.br | |
| Contact: Giovana Fernandes, Mestranda +55 11 25943375 | |
| Sub-Investigator: Jamil Natour, PhD | |
| Ambulatory at UNIFESP | Recruiting |
| São Paulo, Brazil | |
| Contact: Giovana Fernandes, Master +55 11 84987581 gifernandespersonal@hotmail.com | |
| Principal Investigator: Giovana Fernandes, Mestranda | |
Sponsors and Collaborators
Federal University of São Paulo
Investigators
| Principal Investigator: | Giovana Fernandes, Mestranda | Universidade Federal de São Paulo |
More Information
| Responsible Party: | Giovana Fernandes, EVALUATION OF THE EFFECTS OF SWIMMING IN THE TREATMENT OF PATIENTS WITH FIBROMYALGIA, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01547195 History of Changes |
| Other Study ID Numbers: |
0360/10 |
| Study First Received: | February 21, 2012 |
| Last Updated: | March 28, 2012 |
Keywords provided by Giovana Fernandes, Federal University of São Paulo:
|
fibromyalgia swimming |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 27, 2017