Home-based Pulmonary Rehabilitation in Interstitial Lung Disease

NCT07830602 · tracked via the Priya Life Science India tracker

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Phase

Not applicable

Started

2025-11-01

Last updated

2026-10-05

Condition(s) studied

Interstitial Lung Diseases

Investigational drug(s) / intervention(s)

Home-based pulmonary rehabilitationStandard-of-care treatment

Home-based pulmonary rehabilitation: A standard exercise regimen will be taught to the subject at the randomization visit. The exercise regimen will be tailored only if the standard set cannot be followed by the subject and the individualized regimen will be recorded. The subject will be asked to complete a daily diary of activities. A telephonic follow up will be done every week for 8 weeks.

Standard-of-care treatment: The standard of care pharmacologic treatment will be continued along with a general advice on maintaining an active and healthy lifestyle.

Study summary

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. The study hypothesis is that participants undergoing HPR will demonstrate clinically meaningful improvements in disease-specific HRQoL and six-minute walk distance compared to those receiving usual care.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Age between 18 and 75 years 2. Diagnosis of an ILD by clinician using standard guidelines 3. Having breathlessness graded 1 to 3 on the modified Research Council (mMRC) scale 4. On stable therapy with immunosuppressants or antifibrotics for 3 or more months Exclusion Criteria: 1. Pregnant or lactating women 2. Unwilling to participate in the study 3. Not able to walk or perform upper and lower limb movements 4. Requiring supplemental oxygen

Primary outcome measure(s)

Change in the ILD health-related quality-of-life assessed using the King's Brief ILD questionnaire score — 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. Total and domain scores range from 0 to 100, where higher scores indicate better health-related quality of life. The minimal clinically important difference is 5 points. It will be completed by the study subjects at baseline and 8 weeks.

Trial sites (1)

Facility	City	Region	Status
Post graduate Institute of Medical Education and Research	Chandigarh	Chandigarh	Recruiting