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临床试验/NCT00550641
NCT00550641已完成4 期

Pool-based Exercise in Fibromyalgia Management: a Prospective Randomized Comparison Between Stretching and Ai Chi

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2006年3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
90
试验地点
2
主要终点
Improvement in fibromyalgia symptomatology

研究概览

简要总结

Pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management, but different non-pharmacologic measures, especially physical therapies and psychologically-based interventions, have also shown to be effective in the treatment of this disease. The objective of the present randomized controlled trial is to compare the efficacy and tolerability of two different modalities of active low-impact exercise in warm water: stretching and Ai Chi. Each group of patients will receive 18 physiotherapy sessions lasting 60 minutes and will be evaluated at baseline, at treatment termination, and after 4 and 12 weeks of follow up. Main outcome measures are the Fibromyalgia Impact Questionnaire (FIQ) and the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures include the Beck Depression Inventory (BDI), the State and Trait Anxiety Inventory (STAI), and the SF-12 Health Survey (SF-12. Data analysis will be done using repeated measures ANOVA, unpaired Student's t test, and effect sizes' estimation (ES).

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

Improvement in fibromyalgia symptomatology

时间窗: 18 weeks

次要结局

  • Improvement in sleep, depressive and anxiety symptomatology and quality of life(18 weeks)

研究者

申办方类型
Other

研究点 (2)

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