Fibrotic Interstitial Lung DiseaseNCT05130034
Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease
A study testing Home-based pulmonary rehabilitation in people with Fibrotic Interstitial Lung Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to gather information on the effectiveness of a home-based pulmonary rehabilitation program with health coaching and tele-monitoring for improving patient-reported respiratory-related quality of life and physical activity in patients with fibrotic Interstitial Lung Diseases (f-ILD). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Fibrotic Interstitial Lung Disease
- What is being tested?
- Home-based pulmonary rehabilitation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic pulmonary fibrosis (IPF) or other fibrotic interstitial lung disease, with a minimum of > 10% fibrosis on computed tomography imaging.
- Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score >1.
Who cannot join
- Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
- Cognitive impairment or inability to understand and follow instructions.
- Traditional PR completed within 3 months of study recruitment.
- Hospice or end-of-life care at the time of screening.
- Acute exacerbation at the time of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Home-based Pulmonary Rehabilitation and Health Coaching to Improve Respiratory-related Quality of Life and Physical Activity in Fibrotic Interstitial Lung Disease
The purpose of this study is to gather information on the effectiveness of a home-based pulmonary rehabilitation program with health coaching and tele-monitoring for improving patient-reported respiratory-related quality of life and physical activity in patients with fibrotic Interstitial Lung Diseases (f-ILD).
Read the detailed description
The home-based pulmonary rehabilitation program involves using a computer tablet paired with a pulse oximeter and activity tracker. Gentle upper body exercises, walking and a breathing practice are completed by following along on the computer tablet. Weekly check-in calls by telephone will be provided by a Health Coach to assess clinical status and monitor progress. The exercise portion of the program lasts 12 weeks. There are questionnaires and a research grade activity tracker measuring baseline and post-intervention findings at the end of 12-week period.
- Conditions
- Fibrotic Interstitial Lung Disease
- Being tested
- Home-based pulmonary rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based pulmonary rehabilitationBehavioural
Home-based tablet-assisted pulmonary rehabilitation with monitoring technology and telephonic health coach calls using motivational interviewing techniques
| Study group | Role | What they receive |
|---|---|---|
| Home-based pulmonary rehab for fibrotic interstitial lung disease | Experimental | Subjects diagnosed with fibrotic interstitial lung disease will participate in a home-rehab program that promotes more physical activity in daily life. Receives: Behavioral: Home-based pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported respiratory-related quality of life CRQ Physical Summary score
Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The Physical Summary score combines dyspnea and fatigue dimensions, a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.
Measured: Baseline, 12 weeks
Change in patient-reported respiratory-related quality of life CRQ Emotional score
Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The emotional domain score is measured by a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.
Measured: Baseline, 12 weeks
Physical activity
Measured by mean number of steps per 24-hour period as assessed by Actigraphy, pre- and post-intervention
Measured: Baseline, 12 weeks
Secondary outcomes (2)
Qualitative assessment of patient-reported efficacy
Measured at the end of study through qualitative interviews using structured interview guide, combined with primary outcomes using mixed-methods analysis. Potential themes of relevance being sought include changes in patient perception of disease severity, overcoming emotional and physical burden of disease, and feasibility and long-term utility of the intervention.
Measured: 12 weeks
Self-reported tolerance of directed medical management
Pre and post-intervention assessment of patient-reported side-effect severity from medical management
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start13 Dec 2021
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrotic Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Teng Moua, Mayo Clinic
- Investigators
- Teng Moua, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130034
- Sponsor's protocol ID
- 21-006804
- Status last verified
- May 2025
- First submitted
- 10 Nov 2021
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Pulmonary Rehabilitation and Health Coaching to Improve Respiratory-related Quality of Life and Physical Activity in Fibrotic Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05130034
- Acronym / sponsor ID
- 21-006804
- Conditions
- Fibrotic Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 22 Nov 2021 (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.
The purpose of this study is to gather information on the effectiveness of a home-based pulmonary rehabilitation program with health coaching and tele-monitoring for improving patient-reported respiratory-related quality of life and physical activity in patients with fibrotic Interstitial Lung Diseases (f-ILD).
Detailed description
The home-based pulmonary rehabilitation program involves using a computer tablet paired with a pulse oximeter and activity tracker. Gentle upper body exercises, walking and a breathing practice are completed by following along on the computer tablet. Weekly check-in calls by telephone will be provided by a Health Coach to assess clinical status and monitor progress. The exercise portion of the program lasts 12 weeks. There are questionnaires and a research grade activity tracker measuring baseline and post-intervention findings at the end of 12-week period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based pulmonary rehab for fibrotic interstitial lung disease | Experimental | Behavioral: Home-based pulmonary rehabilitationSubjects diagnosed with fibrotic interstitial lung disease will participate in a home-rehab program that promotes more physical activity in daily life. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of idiopathic pulmonary fibrosis (IPF) or other fibrotic interstitial lung disease, with a minimum of > 10% fibrosis on computed tomography imaging.
- Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score >1.
Key exclusion criteria (5 listed)
- Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
- Cognitive impairment or inability to understand and follow instructions.
- Traditional PR completed within 3 months of study recruitment.
- Hospice or end-of-life care at the time of screening.
- Acute exacerbation at the time of screening.
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 rehabilitationHome-based tablet-assisted pulmonary rehabilitation with monitoring technology and telephonic health coach calls using motivational interviewing techniques | Behavioural | Home-based pulmonary rehab for fibrotic interstitial lung disease |
Primary outcome
Change in patient-reported respiratory-related quality of life CRQ Physical Summary score
Time frame: Baseline, 12 weeks
Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The Physical Summary score combines dyspnea and fatigue dimensions, a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.
Change in patient-reported respiratory-related quality of life CRQ Emotional score
Time frame: Baseline, 12 weeks
Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The emotional domain score is measured by a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.
Physical activity
Time frame: Baseline, 12 weeks
Measured by mean number of steps per 24-hour period as assessed by Actigraphy, pre- and post-intervention
2 secondary outcomes
Qualitative assessment of patient-reported efficacy
Time frame: 12 weeks
Self-reported tolerance of directed medical management
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
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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. This study is not recruiting at the moment.
Teng Moua, MD principal investigator
Mayo Clinic
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 in people with Fibrotic Interstitial Lung Disease, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 6 May 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported respiratory-related quality of life CRQ Physical Summary score (time frame: Baseline, 12 weeks). The study lists 3 primary outcomes in all. 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 6 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.