NCT02658370已完成不适用
A Prospective Pilot Study to Evaluate an Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis
Eugen Feist0 个研究点目标入组 30 人开始时间: 2011年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- feasibility of the animated home-based physical exercise program
研究概览
简要总结
The purpose of this pilot study is to investigate feasibility and patients´ assessment using an animated home-based exercise program (Software Wii-fit of the Nintendo Wii game console) for patients with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling the 1987 and 2010 American College of Rheumatology (ACR) criteria for rheumatoid Arthritis
- •Disease activity (patients' global assessment, PtGA) < 30 mm under therapy with a biological DMARD according to label
排除标准
- •Flare of RA
- •A previous use of a Wii console for more than 5 hours
结局指标
主要结局
feasibility of the animated home-based physical exercise program
时间窗: 12 weeks
to be assessed by qualitative interview analysis
次要结局
- patient's visual analogue scale for pain(12 weeks)
- 6-minute walk test(12 weeks)
- patient's visual analogue scale for disease activity(12 weeks)
- muscle strenght measurement(12 weeks)
- respiratory function test(12 weeks)
- Health Assessment Questionnaire Disability Indes (HAQ-DI)(12 weeks)
- short form 36 questionnaire (SF36)(12 weeks)
研究者
Eugen Feist
MD
Charite University, Berlin, Germany
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