NCT01891071Unknown不适用
Lung Volume Recruitment for Lung Function and Cough Impairment in Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Rate of decline of FVC (forced vital capacity)
研究概览
简要总结
Multiple sclerosis is a neurological disease that can affect lung function and cough efficacy. This pilot study will examine whether the lung volume recruitment technique can slow down the decline in lung function and cough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of multiple sclerosis, diagnosed by a neurologist in accordance with the 2010 McDonald criteria
排除标准
- •Concomitant parenchymal pulmonary disease or pleural disease
- •Symptomatic cardiomyopathy
- •Unable to perform pulmonary function testing or lung volume recruitment, due to comprehension or cooperation issues, physical inability such as bulbar or cerebellar dysfunction
- •Contra-indication to pulmonary function testing or lung volume recruitment such as myocardial infarction, bleeding aortic aneurysm, intracranial hemorrhage within the previous month
- •Known susceptibility to pneumothorax or pneumomediastinum
- •Not competent to provide informed consent
结局指标
主要结局
Rate of decline of FVC (forced vital capacity)
时间窗: up to 9 months
次要结局
- Rate of decline of peak cough flow(baseline, 2, 4, 6 and 9 months)
- Change from baseline in FVC at 2, 4, 6 and 9 months(baseline vs 2, 4, 6 and 9 months)
- Change from baseline in peak cough flow at 2, 4, 6 and 9 months(baseline vs 2, 4, 6 and 9 months)
研究者
研究点 (4)
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