Effects of Swimming in the Treatment of Fibromyalgia (ESTF)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2012 by Federal University of São Paulo.
Recruitment status was Recruiting

Sponsor:

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

History of Changes

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:

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


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: 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.

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:

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.

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)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority:	Brazil: Ethics Committee

Keywords provided by 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 September 27, 2016

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