Clinical trial NCT01547195: Effects of Swimming in the Treatment of Fibromyalgia
Official title: Assessment of the Effects of Swimming in the Treatment of Patients With Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Fibromyalgia
Keywords: fibromyalgia
swimming
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Diminishing of pain
timeFrame: 3 months
Secondary outcomes:
measure: Improving quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
state: SP
city: São Paulo
country: Brazil
facility: Ambulatory at UNIFESP
Study officials:
affiliation: Universidade Federal de São Paulo
name: Giovana Fernandes, Mestranda
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandes G, Jennings F, Nery Cabral MV, Pirozzi Buosi AL, Natour J. Swimming Improves Pain and Functional Capacity of Patients With Fibromyalgia: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1269-75. doi: 10.1016/j.apmr.2016.01.026. Epub 2016 Feb 20.