NCT02370654已完成不适用
Chen-style Tai Chi in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease
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
- 44
- 试验地点
- 1
- 主要终点
- Change from baseline dyspnea at 12 weeks
研究概览
简要总结
This study will evaluate the effects of Chen-style Tai Chi compared to conventional exercise in pulmonary rehabilitation for COPD patients. Half of participants will receive the Chen-style Tai Chi intervention, while the other half will receive the conventional exercise intervention. Both groups will receive the same eduction and support during pulmonary rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1 between 30 and 80% of the predicted normal values
- •FEV1/FVC ratio < 70%
排除标准
- •Patients with very severe COPD (GOLD IV);
- •Patients that had a COPD exacerbations within the preceding 2 weeks of the baseline assessments;
- •Significant hypoxemia at rest or during exercise (SpO2 <85%);
- •Already following a rehabilitation program;
- •Have physical limitations that compromises participation to a Tai chi and a conventional exercise program
研究组 & 干预措施
Tai Chi
Experimental
12 week Tai chi intervention, 3 sessions per week, 90 minutes per session
干预措施: Tai chi (Behavioral)
Conventional exercise
Active Comparator
12 week conventional exercise intervention, 3 sessions per week, 90 minutes per session
干预措施: Conventional exercise (Behavioral)
结局指标
主要结局
Change from baseline dyspnea at 12 weeks
时间窗: Baseline, 12 weeks
Dyspnea will be assessed using the chronic respiratory questionnaire (CRQ)
次要结局
- Change from baseline lung function at week 12 (Spirometry and whole-body plethysmography)(Baseline, 12 weeks)
- Change from baseline of composite serum and plasma biomarkers at 12 weeks(Baseline, 12 weeks)
- Change from baseline isokinetic quadriceps muscle function at 12 weeks(Baseline, 12 weeks)
- Change from baseline physical activity at 12 weeks (participants will be equipped with a physical activity monitor)(Baseline, 12 weeks)
- Change from baseline health status at 12 weeks (determined with the COPD Assessment test (CAT).(Baseline, 12 weeks)
- Change from baseline exercise capacity at 12 weeks(Endurance time during a constant work rate bicycle ergometry exercise test)(Baseline, 12 weeks)
- Change from baseline balance (Berg Balance Test (BBT) at 12 weeks(Baseline, 12 weeks)
- Change from baseline walking distance at 12 weeks (distance walked during the six-minute walk test)(Baseline, 12 weeks)
- Change from baseline isometric quadriceps muscle strength at 12 weeks (force of the dominant quadriceps will be measured during a single magnetic stimulation of the femoral nerve)(Baseline, 12 weeks)
- Change from baseline quality of life (QoL) at 12 weeks(Baseline, 12 weeks)
研究者
研究点 (1)
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