A Non-pharmacological Cough Control Therapy as an Adjuvant of Pulmonary Rehabilitation in People With Interstitial Lung Diseases and Chronic Cough - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Feasibility of intervention
研究概览
简要总结
Coughing affects almost all individuals with ILD leading to physical, psychological and social distress and prevents individuals from performing their activities of daily living, working or socialising in public places. Unfortunately, there are no licensed medications available to treat chronic cough and the few drugs that have been tried resulted in little efficacy and significant side effects. Drug-free cough control interventions have shown promise in reducing the severity and impact of coughing on patients' lives but have not been tested in individuals with ILD. This study aims to explore the feasibility and effectiveness of a non-pharmacological cough control therapy, as an adjuvant of pulmonary rehabilitation, in patients with ILD and chronic cough (>8 weeks in duration).
详细描述
Research questions and hypotheses
i) Is a non-pharmacological cough control therapy feasible to treat chronic cough in patients with ILD? Hypothesis: Given the results of previous non-pharmacological interventions in patients with refractory cough, we predict that this intervention will be feasible and well accepted in patients with ILD.
ii) Is a non-pharmacological cough control therapy more effective than pulmonary rehabilitation (PR) alone to treat chronic cough in patients with ILD? Hypotheses: Given the results of previous non-pharmacological interventions in patients with refractory cough, we predict that improvements observed in participants receiving the non-pharmacological intervention will exceed those receiving PR alone. Improvements are expected in HRQOL (exceeding the minimal clinically important difference), intensity of cough-related sensations and symptoms of fatigue.
Research Design The proposed research is a feasibility pre-post intervention study.
Study details:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals will be included if having confirmed diagnosis of any ILD by a physician (as per Canadian Thoracic Society's guideline for evaluating patients with fibrotic interstitial lung disease) and a chronic cough lasting more than 8 weeks in duration
排除标准
- •self-reports of moderate or large sputum production
- •effective or suspected exacerbation of the respiratory condition in the past month
- •upper respiratory tract infection in the past month
- •use of angiotensin-converting enzyme inhibitor medication
- •changes in the prescribed medication in the previous month
- •evidence of traction bronchiectasis in the HRCT
- •evidence of other medical conditions that prevent performance of an exercise training program
- •unable to read or speak in English / unable to provide informed consent.
结局指标
主要结局
Feasibility of intervention
时间窗: through study completion, average 1 year
intervention feasibility will be reflected by the number of eligible patients enrolling (enrolment rate of at least 75%) and completing the intervention (attendance rate of at least 80%), compliance with the sessions and adverse events.
次要结局
- Leicester cough questionnaire(through study completion, average 1 year)
- The King's Brief Interstitial Lung Disease (KBILD)(through study completion, average 1 year)
- Modified Borg scale (mBorg)(through study completion, average 1 year)
- Cough Hypersensitivity Questionnaire (CHQ)(through study completion, average 1 year)
- Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)(through study completion, average 1 year)
- Global rating of change questionnaire (GRCQ)(through study completion, average 1 year)
- Satisfaction of cough therapy program(through study completion, average 1 year)
研究者
Dina Brooks
Senior Scientist
West Park Healthcare Centre