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 2026-10-05.
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. 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.
680 studies on the registry are indexed under Lung Diseases, Interstitial; 246 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 384 interventional studies indexed under Lung Diseases, Interstitial.
Browse Lung Diseases, Interstitial studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 298 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. 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.
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. The mMRC scale score ranges from 0 to 4, where higher scores
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, Statistical analysis plan
Time frame: After publication of the primary manuscript
Access criteria: Deidentified data will be provided on a reasonable request only if aimed at a non-commercial, scientific and academic purpose
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Feb 2027, 15 months after the start.
Of 114 non-industry interventional studies with no phase under Lung Diseases, Interstitial, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's planned 15 months is below that.
Counting every sponsor, half of 118 studies reached it within 27 months; a quarter within 14 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Post Graduate Institute of Medical Education and Research, Chandigarh →