NCT01998724已完成不适用
Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Feasibility of tai chi intervention
研究概览
简要总结
The main purpose of this study is to determine the feasibility and effects of a 6-month tai chi exercise program as compared to a 6-month group walking program and standard care for patients with COPD that have recently completed a pulmonary rehabilitation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD defined as FEV1 (Forced expiratory volume in 1 second)/FVC (Forced vital capacity) <0.70 or chest CT evidence of emphysema
- •Age > 40 years
- •Any severity of COPD as defined by GOLD (Global Obstructive Lung Disease) stages 1, 2,3, or 4
- •Completion of standard pulmonary rehabilitation of at least 8 weeks duration within 24 weeks prior to study entry* *Defined as attending 65% of the program's sessions with a minimum of 10 sessions
排除标准
- •COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
- •Hypoxemia on walk test (O2 sat < 85% on oxygen)
- •Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
- •Clinical signs of unstable cardiovascular disease (ie. chest pain on walk test)
- •Severe cognitive dysfunction (documented Mini-Mental Status Exam ≤ 24)
- •Non-English speaking
- •Current regular practice of tai chi
- •Current diagnosis of lung cancer or treated for lung cancer within the past 5 years
- •Unstable/untreated mental health issue that precludes informed consent or otherwise affects ability to participate in the intervention
研究组 & 干预措施
Standard Care
No Intervention
No intervention
Tai Chi Exercise
Experimental
24 week Tai Chi intervention designed for individuals with COPD
干预措施: Tai Chi (Behavioral)
Group Walking Exercise
Experimental
24 week group walking intervention
干预措施: Group Walking (Behavioral)
结局指标
主要结局
Feasibility of tai chi intervention
时间窗: 24 weeks
Willingness to participate, adherence, and safety
次要结局
- Change from baseline - Dyspnea(Baseline, 12 weeks, 24 weeks, 1 year)
- Change from baseline - Exercise Efficacy(Throughout study)
- Changes from baseline - Pulmonary function(Baseline, 12 weeks, 24 weeks)
- Change from baseline - Exercise capacity(Baseline, 12 weeks, 24 weeks)
- Change from baseline - Disease specific quality of life(Baseline, 12 weeks, 24 weeks, 1 year)
- Change from baseline - Psychosocial well-being(Baseline, 12 weeks, 24 weeks, 1 year)
研究者
Gloria Y. Yeh
Associate Professor of Medicine
Beth Israel Deaconess Medical Center
研究点 (4)
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