Interstitial Lung DiseasesNCT07830602
Home-based Pulmonary Rehabilitation in Interstitial Lung Disease
A study testing Home-based pulmonary rehabilitation and Standard-of-care treatment in people with Interstitial Lung Diseases, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Interstitial Lung Diseases
- What is being tested?
- Home-based pulmonary rehabilitation and Standard-of-care treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating women
- Unwilling to participate in the study
- Not able to walk or perform upper and lower limb movements
- Requiring supplemental oxygen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Post graduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
Ashutosh Nath Aggarwal, MD, DM, +91 172 2756824, aggarwal.ashutosh@outlook.com
About this study
Official title: A Randomized Trial of Home-Based Pulmonary Rehabilitation in Interstitial Lung Disease
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.
- Conditions
- Interstitial Lung Diseases
- Being tested
- Home-based pulmonary rehabilitation, Standard-of-care treatment
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based pulmonary rehabilitationOther
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 treatmentOther
The standard of care pharmacologic treatment will be continued along with a general advice on maintaining an active and healthy lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard-of-care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Nov 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahajal Dhooria, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830602
- Sponsor's protocol ID
- INT/IEC/2025/SPL1154
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Home-Based Pulmonary Rehabilitation in Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07830602
- Acronym / sponsor ID
- INT/IEC/2025/SPL1154
- Conditions
- Interstitial Lung Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care plus home-based pulmonary rehabilitation | Active comparator | Other: Home-based pulmonary rehabilitation, Other: Standard-of-care treatmentSubjects in this arm will receive the study intervention (home-based pulmonary rehabilitation) and the standard-of-care treatment for interstitial lung disease. |
| Standard-of-care treatment plus no intervention | Other | Other: Standard-of-care treatmentSubjects in this arm will receive no additional intervention but only the standard-of-care treatment for interstitial lung disease. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Unwilling to participate in the study
- Not able to walk or perform upper and lower limb movements
- Requiring supplemental oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based pulmonary rehabilitationA 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. | Other | Standard-of-care plus home-based pulmonary rehabilitation |
| Standard-of-care treatmentThe standard of care pharmacologic treatment will be continued along with a general advice on maintaining an active and healthy lifestyle. | Other | Standard-of-care plus home-based pulmonary rehabilitation, Standard-of-care treatment plus no intervention |
Primary outcome
Change in the ILD health-related quality-of-life assessed using the King's Brief ILD questionnaire score
Time frame: 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.
5 secondary outcomes
Change in dypnoea
Time frame: 8 weeks
Change in six-minute walk distance
Time frame: 8 weeks
Change in quality-of-life assessed by the EQ-5D-5L score
Time frame: 8 weeks
Change in forced vital capacity
Time frame: 8 weeks
Number of adverse events
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based pulmonary rehabilitation and Standard-of-care treatment in people with Interstitial Lung Diseases, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sahajal Dhooria, MD, DM (+91 172 2756827, sahajal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the ILD health-related quality-of-life assessed using the King's Brief ILD questionnaire score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.