The Effects of Pulmonary Rehabilitation in Patients With Non-cystic Fibrosis Bronchiectasis: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Exercise capacity
研究概览
简要总结
Number of Patients:
Study group - Bronchiectasis that is not attributable to Cystic fibrosis
- Group 1 - Pulmonary Rehabilitation
- Group 2 - Standard care
Sample size - 20 in each arm
Study Design:
- Randomised controlled trial (RCT)
All patients who qualify for the study will undergo a detailed evaluation. Baseline assessment will include the following parameters:
- Anthropometry
- Pulmonary Function Tests and Respiratory muscle strength
- Cardiopulmonary Exercise Testing (CPET)
- Six Minute Walk Test (6MWT)
- Severity of dyspnoea (Dyspnoea scale)
- Limb muscle strength
- Inflammatory markers in the serum - C-reactive protein
- Quality of Life
Patients will then be randomized (using table of random numbers) to either the pulmonary rehabilitation group or the standard arm group. After 8 weeks of pulmonary rehabilitation, patients will again be reassessed by the aforementioned tools.
详细描述
METHODOLOGY
Type of study - Randomised controlled trial (RCT)
Study period - March 2014 to July 2016
Place of study - Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences, New Delhi
Study group - Bronchiectasis that is not attributable to Cystic fibrosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age ≥ 18 years
- •Diagnosed bronchiectasis that is not attributable to cystic fibrosis, confirmed radiologically on high resolution computed tomography
- •Exertional dyspnoea (Modified Medical Research Council (mMRC) score ≥ 2 and a history of at least two exacerbations in the past year
- •Willing to give informed consent
排除标准
- •Smoking history ≥ 10 pack years or physician diagnosis of chronic obstructive pulmonary disease
- •A clinical diagnosis of asthma
- •Interstitial lung disease (clinical/radiological diagnosis)
- •Medical conditions which could place the individual at risk during exercise testing or training (eg. angina) or conditions that may restrict the participant's ability to exercise (eg. severe orthopaedic or neurologic impairments);
- •Participation in a PR program within the last 12 months.
- •Patient having an exacerbation of bronchiectasis
结局指标
主要结局
Exercise capacity
时间窗: 8 weeks
Assessed using 6 minute walk distance and cardiopulmonary exercise testing
次要结局
- Lung Functions(8 weeks)
- Anxiety and depressions score(8 weeks)
- Cough related QoL(8 weeks)
- Health Related Quality of Life(8 weeks)
研究者
Dr. Rohit Kumar
Senior Resident
All India Institute of Medical Sciences, New Delhi