Effectiveness of Structured Home-based Pulmonary Rehabilitation program on Functional capacity and Quality of Life in Bronchiectasis: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Functional capacity using Six minute walk distance and quality of life using Bronchiectasis Health Questionnaire and St George respiratory questionnaire
研究概览
简要总结
Bronchiectasis is a chronic respiratory disease with chronic cough and expectoration and exercise intolerance. Out patient based pulmonary rehabilitation is found to be effective in patients with bronchiectasis. However, this is not a feasible model for many patients in resource limited settings. In order to improve accessibility, home based pulmonary rehabilitation models has been tested in other chronic respiratory diseases and found to be effective. Effect of home based pulmonary rehabilitation in bronchiectasis patients with limited resources has not been established. This randomized controlled trial aims to determine the effectiveness of structured home based pulmonary rehabilitation in bronchiectasis patients on functional capacity and health related quality of life. A total of 104 subjects will be randomized into intervention group (n=52) and control group (n=52) using stratified block randomization so that each group has 26 males and 26 females. Outcome assessor will be blinded to group allocation. Intervention group will receive home based pulmonary rehabilitation which includes airway clearance techniques, nutritional advice, physical activity promotion, self management educational booklet, exercise training (strength, aerobic & flexibility training) and dyspnea relieving techniques. Control group will receive standard care as per physician orders which includes medical, physiotherapy and life style management. Outcomes will be assessed at baseline, end of intervention (after 24 sessions) and at the end of 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •A physician diagnosed post exacerbation bronchiectasis patients between the age group 18- 70 years, either gender, any etiology with any mMRC dyspnea grade and Functional vision and hearing.
排除标准
- •Patients who are diagnosed with endocrine, musculoskeletal and neurological disorders which prevent a person from exercising, primary Cardiac disorders and Coronary artery disease.
结局指标
主要结局
Functional capacity using Six minute walk distance and quality of life using Bronchiectasis Health Questionnaire and St George respiratory questionnaire
时间窗: Baseline, 2 months (after 24 sessions) and 3 months
次要结局
- Dyspnea on mMRC scale, Muscular strength using estimated 1 Repetition Maximum, energy cost in walking using Physiological cost index, Body composition using Bioelectrical impedance analyzer, Physical activity level using Stanford 7 day Physical activity recall questionnaire(Baseline, 2 months (after 24 sessions) and 3 months)