Lung FibrosisNCT06751069
Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease
A study testing Home-based Pulmonary Rehab in people with Lung Fibrosis and Lung Interstitial Disease, run by Mayo Clinic at 4 sites in United States.
Trial summary
The purpose of this clinical trial is to determine the impact of a home-based pulmonary rehabilitation program with health coaching on patient-reported respiratory-related quality of life and physical activity, as compared to usual care in patients with fibrotic interstitial lung disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Fibrosis, Lung Interstitial Disease
- What is being tested?
- Home-based Pulmonary Rehab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Mar 2025to 30 Sep 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
- Cognitive impairment or inability to understand and follow instructions
- Traditional center-based PR completed within 3 months of initial study recruitment
- Transition to hospice or end-of-life care at the time of screening
- Acute exacerbation at the time of screening
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Hassan Z Baig, MD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Scott Rajala, 612-624-8511, srajala@umn.edu
Hyun Kim, MD
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Johanna Hoult, MS, 507-293-1989, hoult.johanna@mayo.edu
Teng Moua, MD
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Ana Zamora Martinez, MD
About this study
Official title: Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial
The purpose of this clinical trial is to determine the impact of a home-based pulmonary rehabilitation program with health coaching on patient-reported respiratory-related quality of life and physical activity, as compared to usual care in patients with fibrotic interstitial lung disease.
Read the detailed description
The fibrotic interstitial lung diseases (f-ILD) are a group of progressive and debilitating lung diseases sharing characteristics of lung scarring on imaging and restricted breathing on pulmonary function testing (PFT). Symptoms include shortness of breath, cough, and fatigue, eventually leading to deconditioning and poor quality of life. While medical therapies are available for slowing or stopping the loss of lung function, only pulmonary rehabilitation (PR) has shown a positive impact on patient-reported shortness of breath and physical activity. Unfortunately, PR may not be widely available to all patients, and some patients may become too ill to participate in traditional center-based programs.
A primary hypothesis is that modifying the content, delivery, and setting for PR in patients with f-ILD to improve access or ease of use and supporting behavior change through a health coach will have a measurable and sustained positive impact on patient well-being and quality of life as compared to no participation or non-use.
- Conditions
- Lung Fibrosis, Lung Interstitial Disease
- Being tested
- Home-based Pulmonary Rehab
- Medical subject headings
- Pulmonary Fibrosis, 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 RehabBehavioural
Participants are expected to engage in the home-based PR routine five to six days a week for the entire 12-week study period. The PR routine begins with slow upper body and timed breathing exercises, followed by two slow balance walks for 6 minutes each. The total exercise time is 24 minutes a day followed by a 4-minute mindful breathing meditation/cool down. Exercises may be modified or repeated according to baseline activity level and as conditioning improves.
| Study group | Role | What they receive |
|---|---|---|
| Home-based Pulmonary Rehabilitation with Health Coaching Group | Experimental | Twelve-week intervention with home-based pulmonary rehabilitation and health coaching. Receives: Behavioral: Home-based Pulmonary Rehab |
| Non-use Waitlist Control Observation Group | No intervention | 12-week non-use usual care waitlist with transition to intervention group at the end of the observation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
King's Brief Interstitial Lung Disease (K- BILD)
Respiratory-related quality of life questionnaire
Measured: Baseline, end of intervention (3 months), and 3 months post-intervention
Physical activity as measured by change in mean number of steps per day
Mean number of steps as measured by Actigraph monitor over 5-7 days
Measured: Baseline, end of intervention (3 months), and 3 months post-intervention
Secondary outcomes (4)
Modified Medical Research Council (mMRC)
dyspnea scale
Measured: Baseline, end of intervention (3 months), and 3 months post-intervention
Living with Pulmonary Fibrosis (L-PF)-Symptoms and Impacts Questionnaire
Respiratory-related quality of life questionnaire
Measured: Baseline, end of intervention (3 months), and 3 months post-intervention
FACIT Fatigue Scale
Fatigue assessment questionnaire
Measured: Baseline, end of intervention (3 months), and 3 months post-intervention
Leicester Cough Questionnaire (LCQ)
Cough severity assessment questionnaire
Measured: Baseline, end of intervention (3 months), and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start3 Mar 2025
- Primary completion1 Jul 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung FibrosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized waitlist control
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Teng Moua, Mayo Clinic
- Investigators
- Teng Moua, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751069
- Sponsor's protocol ID
- 24-007966
- Status last verified
- Mar 2026
- First submitted
- 20 Dec 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial
- ClinicalTrials.gov ID
- NCT06751069
- Acronym / sponsor ID
- 24-007966
- Conditions
- Lung Fibrosis, Lung Interstitial Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 27 Dec 2024 (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 clinical trial is to determine the impact of a home-based pulmonary rehabilitation program with health coaching on patient-reported respiratory-related quality of life and physical activity, as compared to usual care in patients with fibrotic interstitial lung disease.
Detailed description
The fibrotic interstitial lung diseases (f-ILD) are a group of progressive and debilitating lung diseases sharing characteristics of lung scarring on imaging and restricted breathing on pulmonary function testing (PFT). Symptoms include shortness of breath, cough, and fatigue, eventually leading to deconditioning and poor quality of life. While medical therapies are available for slowing or stopping the loss of lung function, only pulmonary rehabilitation (PR) has shown a positive impact on patient-reported shortness of breath and physical activity. Unfortunately, PR may not be widely available to all patients, and some patients may become too ill to participate in traditional center-based programs.
A primary hypothesis is that modifying the content, delivery, and setting for PR in patients with f-ILD to improve access or ease of use and supporting behavior change through a health coach will have a measurable and sustained positive impact on patient well-being and quality of life as compared to no participation or non-use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized waitlist control
| Arm | Type | Receives |
|---|---|---|
| Home-based Pulmonary Rehabilitation with Health Coaching Group | Experimental | Behavioral: Home-based Pulmonary RehabTwelve-week intervention with home-based pulmonary rehabilitation and health coaching. |
| Non-use Waitlist Control Observation Group | No intervention | –12-week non-use usual care waitlist with transition to intervention group at the end of the observation period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
- Cognitive impairment or inability to understand and follow instructions
- Traditional center-based PR completed within 3 months of initial study recruitment
- Transition to 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 RehabParticipants are expected to engage in the home-based PR routine five to six days a week for the entire 12-week study period. The PR routine begins with slow upper body and timed breathing exercises, followed by two slow balance walks for 6 minutes each. The total exercise time is 24 minutes a day followed by a 4-minute mindful breathing meditation/cool down. Exercises may be modified or repeated according to baseline activity level and as conditioning improves. | Behavioural | Home-based Pulmonary Rehabilitation with Health Coaching Group |
Primary outcome
King's Brief Interstitial Lung Disease (K- BILD)
Time frame: Baseline, end of intervention (3 months), and 3 months post-intervention
Respiratory-related quality of life questionnaire
Physical activity as measured by change in mean number of steps per day
Time frame: Baseline, end of intervention (3 months), and 3 months post-intervention
Mean number of steps as measured by Actigraph monitor over 5-7 days
4 secondary outcomes
Modified Medical Research Council (mMRC)
Time frame: Baseline, end of intervention (3 months), and 3 months post-intervention
Living with Pulmonary Fibrosis (L-PF)-Symptoms and Impacts Questionnaire
Time frame: Baseline, end of intervention (3 months), and 3 months post-intervention
FACIT Fatigue Scale
Time frame: Baseline, end of intervention (3 months), and 3 months post-intervention
Leicester Cough Questionnaire (LCQ)
Time frame: Baseline, end of intervention (3 months), and 3 months post-intervention
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 20 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Lung Fibrosis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
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.
Teng Moua principal investigator
Mayo Clinic
4 sites 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 Rehab in people with Lung Fibrosis and Lung Interstitial Disease, run by Mayo Clinic at 4 sites 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 0 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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 Johanna Hoult, MS (507-293-1989, hoult.johanna@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
King's Brief Interstitial Lung Disease (K- BILD) (time frame: Baseline, end of intervention (3 months), and 3 months post-intervention). The study lists 2 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 20 Mar 2026.