Effects of Swimming in the Treatment of Fibromyalgia (ESTF)

March 28, 2012 updated by: Giovana Fernandes, Federal University of São Paulo

Assessment of the Effects of Swimming in the Treatment of Patients With Fibromyalgia.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Ambulatory at UNIFESP
        • Contact:
        • Principal Investigator:
          • Giovana Fernandes, Mestranda
    • SP
      • São Paulo, SP, Brazil
        • Recruiting
        • Universidade Federal de Sao Paulo
        • Contact:
        • Contact:
          • Giovana Fernandes, Mestranda
          • Phone Number: +55 11 25943375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Walk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Giovana Fernandes, Mestranda, Universidade Federal de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

March 3, 2012

First Posted (ESTIMATE)

March 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 30, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0360/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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