NCT01551953已完成2 期
BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 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 feasibility and effects of tai chi and mind-body breathing in patients with COPD.
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
- •Moderate-severe COPD
- •Age ≥ 40 years
排除标准
- •Subjects with respiratory failure or GOLD stage 4 who are unable to safely perform a 6 minute walk test or otherwise safely exercise as deemed by a physician.
- •COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
- •Planned major pulmonary intervention within the next 3 months
- •Hypoxemia on walk test or cardiopulmonary exercise test
- •Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
- •Clinical signs of unstable cardiovascular disease
- •Severe cognitive dysfunction
- •Non-English speaking
- •Current active participation in pulmonary rehabilitation program or current regular practice of tai chi
- •Physician diagnosis of unstable/untreated clinical depression
- •History of lung cancer
结局指标
主要结局
Feasibility of tai chi intervention
时间窗: 12 weeks
Willingness to participate, adherence, and safety
次要结局
- Change from baseline- Exercise capacity(baseline, 12 weeks, 24 weeks)
- Change from baseline- Dyspnea(baseline, 12 weeks, 24 weeks)
- Change from baseline- Psychosocial well-being(baseline, 12 weeks, 24 weeks)
- Change from baseline- Physical strength and flexibility(baseline, 12 weeks, 24 weeks)
- Change from baseline- Disease specific quality of life(baseline, 12 weeks, 24 weeks)
- Change from baseline- Pulmonary function(baseline, 12 weeks, 24 weeks)
研究者
Gloria Y. Yeh
Associate Professor of Medicine
Beth Israel Deaconess Medical Center
研究点 (4)
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