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临床试验/NCT00600574
NCT00600574已完成4 期

A Randomized Controlled Trial Comparing the Efficay and Tolerability of Ai Chi Versus Stretching in Fibromyalgia Management: a Six Months Study

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
94
试验地点
2
主要终点
Fibromialgya Impact Questionnaire

研究概览

简要总结

The purpose of the study is to compare the efficacy and tolerability of Ai Chi, an adaptation of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology.

详细描述

Physical therapies have shown to be effective in the treatment of fibromyalgia and It is generally assumed that a multidisciplinary approach, combining both pharmacologic and non-pharmacologic measures, is probably the optimal treatment approach for most fibromyalgia patients. As these patients are usually physically deconditioned, low-intensity exercise has been recommended at least as initial treatment. At this respect, exercise in warm water is considered a good option as both temperature and water buoyancy minimize body weight's stress and help patients to minimize pain. In a previous study comparing short term physiotherapy with stretching and Ai Chi we found that Ai Chi was at least as effective as stretching and induced a significant reduction in fibromyalgia core symptomatology and in sleep parameters. The objective of the present randomized controlled study is to compare both physiotherapy techniques in a long term basis.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of fibromyalgia according to the ACR criteria
  • 18 years or older
  • written informed consent to participate

排除标准

  • unable to tolerate warm chlorinated water
  • associated medical condition contraindicating exercise in warm water

结局指标

主要结局

Fibromialgya Impact Questionnaire

时间窗: baseline, 6 months, 1 year

次要结局

  • Brief Pain Inventory(baseline, 6 months, 12 months)
  • SF-36 Health Survey(baseline, 6 months, 12 months)
  • Pittsbugh Sleep Quality Index(baseline, 6 months, 12 months)
  • Hospital Anxiety and Depression Scale(baseline, 6 months, 12 months)
  • Adverse reaction recording(baseline, 6 months, 12 months)

研究者

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

Elena Pita Calandre

Professor of Pharmacology

Universidad de Granada

研究点 (2)

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Ai Chi Versus Stretching in Fibromyalgia Management | 临床试验