Home-based Pulmonary Rehabilitation in Interstitial Lung Disease

NCT07830602 | Recruiting

• 1 other identifier: INT/IEC/2025/SPL1154
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Interstitial Lung Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

Standard-of-care plus home-based pulmonary rehabilitation

ACTIVE COMPARATOR

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

Standard-of-care treatment plus no intervention

OTHER

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

Interventions

Home-based pulmonary rehabilitation OTHER

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 plus home-based pulmonary rehabilitation

Standard-of-care treatment OTHER

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

Standard-of-care plus home-based pulmonary rehabilitation; Standard-of-care treatment plus no intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating women
• Unwilling to participate in the study
• Not able to walk or perform upper and lower limb movements
• Requiring supplemental oxygen

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sahajal Dhooria, MD, DM

CONTACT

+91 172 2756827; sahajal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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

Locations

IN (1)