NCT01919645已完成不适用
Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality in Women With Rheumatoid Arthritis: A Randomized Clinical Trial Study
Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2012年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Improvement of sleep through a polysomnogram exam.
研究概览
简要总结
Physical exercise programs are effective and safe for the improvement of the sleep efficiency in patients with Rheumatoid Arthritis.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ages 35-65 years diagnosed with Rheumatoid Arthritis according with the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR)Criteria; Pittsburgh Sleep Quality Index ≥ 5; electrocardiogram test (ECG) at rest and at regular effort.
排除标准
- •Patients with joint restrictions due to disease.
- •Other rheumatoid-associated diseases (Fibromyalgia) with the exception of Osteoarthritis of low degree.
- •Those who are uncontrollably hypertense, diabetic, with thyroidopathy and cardiorespiratory diseases which stop them from practicing exercises.
- •Class II obesity (IMC ≥ 35 Kg/m2).
- •Cognitive deficits.
- •Depression.
- •Patients not following the study rules such as exercise hours and / or time for the proposed program.
- •Current physical exercise practitioner.
- •Those undergoing medication treatment which would interfere sleep.
- •Night shift workers who disrespect regular working schedule.
结局指标
主要结局
Improvement of sleep through a polysomnogram exam.
时间窗: at baseline and at end-week 16
Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises.
次要结局
未报告次要终点
研究者
Andrea Kayo
PhD Student
Federal University of São Paulo
研究点 (2)
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