A Randomized Trial of Home-Based Pulmonary Rehabilitation in Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in the ILD health-related quality-of-life assessed using the King's Brief ILD questionnaire score
研究概览
简要总结
Pulmonary rehabilitation (PR) is a comprehensive, multidisciplinary intervention incorporating exercise training, education, and behavior change, shown to improve dyspnea, exercise capacity, and health-related quality of life (HRQoL) in ILD patients. However, access to center-based PR is limited in many settings, including ours, due to geographic, logistical, and socioeconomic barriers. Home-based pulmonary rehabilitation (HPR) may offer a scalable, accessible alternative with comparable outcomes to conventional PR. The drawback of HPR is the lack of monitoring, which may be overcome by incorporating a telemonitoring program to improve adherence. Data on the effectiveness of HPR in ILD populations-especially in resource-limited settings-are scarce. Therefore, this study aims to evaluate the impact of a 6-week home-based PR program on HRQoL and exercise capacity in patients with fibrotic ILD in India. We hypothesize that participants undergoing HPR will demonstrate clinically meaningful improvements in disease-specific HRQoL and six-minute walk distance compared to those receiving usual care.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Diagnosis of an ILD by clinician using standard guidelines
- •Having breathlessness graded 1 to 3 on the modified Research Council (mMRC) scale
- •On stable therapy with immunosuppressants or antifibrotics for 3 or more months
排除标准
- •Pregnant or lactating women
- •Unwilling to participate in the study
- •Not able to walk or perform upper and lower limb movements
- •Requiring supplemental oxygen
研究组 & 干预措施
Standard-of-care plus home-based pulmonary rehabilitation
Subjects in this arm will receive the study intervention (home-based pulmonary rehabilitation) and the standard-of-care treatment for interstitial lung disease.
干预措施: Home-based pulmonary rehabilitation (Other)
Standard-of-care plus home-based pulmonary rehabilitation
Subjects in this arm will receive the study intervention (home-based pulmonary rehabilitation) and the standard-of-care treatment for interstitial lung disease.
干预措施: Standard-of-care treatment (Other)
Standard-of-care treatment plus no intervention
Subjects in this arm will receive no additional intervention but only the standard-of-care treatment for interstitial lung disease.
干预措施: Standard-of-care treatment (Other)
结局指标
主要结局
Change in the ILD health-related quality-of-life assessed using the King's Brief ILD questionnaire score
时间窗: 8 weeks
King's-Brief Interstitial Lung Disease questionnaire: It is a validated brief health status questionnaire developed especially for patients with ILD. It contains 15 questions that evaluates the health status of patients in three different domains- breathlessness and activities, psychological and chest symptoms. The patient's responses are measured and finally expressed on a scale of 0-100 based on individual responses in each domain. The minimal clinically important difference is 5 points. It will be completed by the study subjects at baseline and 8 weeks.
次要结局
- Change in dypnoea(8 weeks)
- Change in six-minute walk distance(8 weeks)
- Change in quality-of-life assessed by the EQ-5D-5L score(8 weeks)
- Change in forced vital capacity(8 weeks)
- Number of adverse events(8 weeks)
研究者
Sahajal Dhooria
Additional Professor
Post Graduate Institute of Medical Education and Research, Chandigarh