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Effects of Swimming in the Treatment of Fibromyalgia (ESTF)

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ClinicalTrials.gov Identifier: NCT01547195
Recruitment Status : Unknown
Verified March 2012 by Giovana Fernandes, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : March 7, 2012
Last Update Posted : March 30, 2012
Sponsor:
Information provided by (Responsible Party):
Giovana Fernandes, Federal University of São Paulo

Study Description
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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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Procedure: swim training Procedure: Training walk Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Effects of Swimming in the Treatment of Patients With Fibromyalgia.
Study Start Date : January 2012
Actual Primary Completion Date : January 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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:
  • Swimming.
  • Freestyle.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 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