NCT01926275Unknown不适用
Noninvasive Positive Pressure Ventilation Added Inspiratory Muscle Training in Severe Chronic Obstructive Pulmonary Disease
Guangzhou Institute of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
The aim of this study is to determine whether noninvasive positive pressure ventilation with inspiratory muscle training can improve quality of life and respiratory muscle strength than noninvasive positive pressure ventilation or inspiratory muscle training alone.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40-75 years, male or female.
- •Have spirometric evidence of COPD with an FEV1 of < 50% predicted and FEV1/FVC < 0.70, measured within the last 6 months (GOLD stage III and IV). Stable disease since 4 weeks or more prior to randomisation.
- •PCO2 of 7 kPa, combined with a pH of 7.35 or above. These gases must be measured after 30 minutes breathing room air in sitting position
- •No treatment with NPPV and respiratory muscle training in the last 8 weeks
排除标准
- •Smokers can be excluded;
- •Diseases of the lung or thorax besides COPD: OSA Advanced pulmonary fibrosis, advanced bronchiectases, active tuberculosis, post tuberculosis syndrome, pneumonia, severe kyphoscoliosis, tracheostoma, neuromuscular diseases, or any other disorder, which might result in elevated PCO2
- •Body mass index of 35 kg/m² or above. Severe cardiac disease, NYHA IV, instable angina, severe cardiac arrhythmia, especially of ventricular origin (atrial fibrillation is not an exclusion criterion).
- •Local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus.
- •Severe chronic diseases except COPD, hindering the patient to follow the schedule of this study
结局指标
主要结局
Quality of life
时间窗: Change from Baseline in quality of life at 8 weeks
Severe Respiratory Insufficiency (SRI) Questionnaire and chronic obstructive pulmonary disease assessment test(CAT)
次要结局
- respiratory muscle strength(Change from Baseline in respiratory muscle strength at 8 weeks)
- Dyspnea(Change from Baseline in dyspnea at 8 weeks)
- Walked distance in 6MWT(Change from Baseline in walked distance at 8 weeks)
- Frequency of acute exacerbations of COPD(8 week)
- Pulmonary function tests(Change from Baseline in pulmonary function tests at 8 weeks)
- Blood gases levels(Change from Baseline in blood gases levelsat 8 weeks)
- Sleep quality(Change from Baseline in sleep qualityat 8 weeks)
- Length of hospital admission(8 week)
- frequency of of hospital admission(8 week)
研究者
LuQian Zhou
Doctor
Guangzhou Institute of Respiratory Disease
研究点 (1)
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