A Randomized Controlled Trial Comparing the Efficay and Tolerability of Ai Chi Versus Stretching in Fibromyalgia Management: a Six Months Study
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
- 否
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
Elena Pita Calandre
Professor of Pharmacology
Universidad de Granada
