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.
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
Pregnant or lactating women
Unwilling to participate in the study
Not able to walk or perform upper and lower limb movements
Requiring supplemental oxygen
Parallel
Home-based pulmonary rehabilitation
Other interventionA 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
Other interventionThe standard of care pharmacologic treatment will be continued along with a general advice on maintaining an active and healthy lifestyle.
Change in the ILD health-related quality-of-life assessed using the King's Brief ILD questionnaire score
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.
Change in dypnoea
Change in dyspnea will be assessed on modified Medical Research Council \[mMRC\] scale at the end of 8 weeks from randomization. The mMRC scale score ranges from 0 to 4, where higher scores
Change in six-minute walk distance
Mean change in six-minute walk distance will be compared between the study groups at the end of 8 weeks from randomization. Six-minute walk test (6MWT) will be performed using American Thoracic Society guidelines
Change in quality-of-life assessed by the EQ-5D-5L score
Mean change in EQ-5D-5L score will be compared between the study groups at the end of 8 weeks from randomization. EuroQol-5D-5L (EQ-5D-5L) questionnaire is a widely used standardized instrument designed to measure generic health-related quality of life (HRQoL). It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated across five levels of severity. The responses are combined into a single health state index and complemented by a visual analogue scale (VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health). It is applicable across diseases and treatments and will be administered at baseline and 8 weeks.
Change in forced vital capacity
Forced vital capacity will be assessed by spirometry. Spirometry will be performed according to the ATS/ERS guidelines using an ultrasonic flow sensor spirometer (NDD Medizintechnik AG, Zurich, Switzerland).
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