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临床试验/NCT01547195
NCT01547195Unknown1 期

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

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
75
试验地点
2
主要终点
Diminishing of pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Diminishing of pain

时间窗: 3 months

_ Assess the effectiveness of the practice of swimming in reducing pain and improving quality of life in patients with FM.

次要结局

  • Improving quality of life(3 months)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovana Fernandes

EVALUATION OF THE EFFECTS OF SWIMMING IN THE TREATMENT OF PATIENTS WITH FIBROMYALGIA

Federal University of São Paulo

研究点 (2)

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