An interventional study of Home-based pulmonary rehabilitation and Standard-of-care treatment in Interstitial Lung Diseases, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Recruiting at 1 site in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
Subjects in this arm will receive the study intervention (home-based pulmonary rehabilitation) and the standard-of-care treatment for interstitial lung disease.
Other: Home-based pulmonary rehabilitation · Other: Standard-of-care treatment
Subjects in this arm will receive no additional intervention but only the standard-of-care treatment for interstitial lung disease.
Other: Standard-of-care treatment
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.
The 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. The minimal clinically important difference is 5 points. It will be completed by the study subjects at baseline and 8 weeks.
Time frame: 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
Time frame: 8 weeks
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
Time frame: 8 weeks
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.
Time frame: 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).
Time frame: 8 weeks
Number of adverse events
Number of adverse events will be recorded and compared between study groups. These will include disease progression, acute exacerbation, hospitalization, respiratory failure, death, excessive breathlessness, oxygen desaturation, chest pain, chest tightness, palpitations, presyncope/syncope, dizziness, light-headedness, excessive fatigue, weakness, or headache during or after exercise, musculoskeletal pain or injury, including muscle strain, joint pain, back pain, tendon injury, or sprain, exercise-related falls or loss of balance, particularly during stair climbing, squats, heel raises, or unsupported activities, exacerbation of cough or wheeze during exercise, delayed post-exercise symptoms, such as prolonged fatigue, myalgia, or breathlessness persisting for several hours, exercise intolerance requiring reduction or interruption of the prescribed programme.
Time frame: 8 weeks
Plan to share: Yes — Deidentified data relating baseline characteristics of study subjects and key outcomes will be on a reasonable request only if aimed at a non-commercial, scientific and academic purpose
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Post Graduate Institute of Medical Education and Research, Chandigarh