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临床试验/NCT03149198
NCT03149198已完成不适用

Assessment of the Effectiveness of the Mat Pilates Method in the Treatment of Women With Fibromyalgia in the Santa Cruz City, Rio Grande do Norte, Brazil: A Randomized Controlled Trial

Universidade Federal do Rio Grande do Norte2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年9月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Assessment of Pain

研究概览

简要总结

Introduction: Physical exercises have been recommended to improve overall well-being in patients with fibromyalgia, with the main goal of repairing the effects of lack of physical conditioning, and improving symptoms especially pain and fatigue. Very well estimated and widely known are the studies that support the use of the pilates method as effective in improving the symptoms of the disease.

Objective: To evaluate the effectiveness of the soil method in improving pain in women with fibromyalgia in the city of Santa Cruz, RN.

Methodology: This is a randomized controlled trial with blind evaluator, where 60 patients with fibromyalgia diagnosis are divided into two groups. The intervention group, perform an exercise program based on the pilates method in soil and another, considered control group, participate in a program of aerobic exercises in the pool. Both groups conduct supervised exercise programs 2 times a week for a period of 12 weeks. The evaluation instruments used in an EVA (visual pain scale); FIQ Questionnaire - Fibromyalgia Impact Questionnaire; Functional ability by the "Timed Up and Go" test and 6-minute walk test; A quality of sleep by the Pittsburgh Sleep Quality Index (PSQI-BR) and an ESS-BR (Epworth Sleepiness Scale); Finally, a general quality of life for the SF-36.

Statistical analysis: Data are analyzed by t-student, Mann-Whitney test, repeated-measures ANOVA and intention-to-treat analysis.

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
Single (Outcomes Assessor)

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 diagnosed according to the classification criteria of the American College of Rheumatology,
  • aged 18 to 60 years,
  • with VAS between 3 and 8,
  • who signed the free and informed consent term.

排除标准

  • Patients with uncontrolled hypertension;
  • Decompensated cardiorespiratory disease;
  • History of syncopes or arrhythmias induced by physical exercise;
  • Diabetes unbalanced;
  • Psychiatric disorders;
  • History of regular physical exercise (at least 2 times a week) in the last 6 months
  • any other condition that makes it impossible for a patient to perform physical exercises.

研究组 & 干预措施

Interventional group

Experimental

Mat pilates exercises

干预措施: Mat Pilates exercises (Other)

Control group

Active Comparator

Aquatic aerobic exercises

干预措施: Aquatic aerobic exercises (Other)

结局指标

主要结局

Assessment of Pain

时间窗: 12 week

Visual analogic scale (0-10)

次要结局

  • Assessment of Function(12 Week)
  • Assessment of Quality of life(12 week)
  • Assessment of Physical Function(12 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcelo Cardoso de Souza

Prof. Dr.

Universidade Federal do Rio Grande do Norte

研究点 (2)

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