Idiopathic Pulmonary FibrosisNCT04838275
IPF mHealth Exercise Study
A study testing 12-week mHealth home exercise prescription in people with Idiopathic Pulmonary Fibrosis, run by University of Washington at 1 site in United States.
Trial summary
Patients with idiopathic pulmonary fibrosis (IPF) who are stable on antifibrotic therapy at least 3 months will be randomized to complete a 12-week home exercise intervention using an mHealth platform, plus a pre- and post-intervention monitoring period (4 weeks each) and in-person study assessments. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- 12-week mHealth home exercise prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 31 Dec 2024
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80 yrs at randomization
- Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2018 Guidelines
- Percent Forced Vital Capacity (%FVC) ≥50%
- Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30%
- Willing and able to participate in an exercise regimen
- Ambulatory without the use of an assistive device
Show all 9Show fewer
- Stable on antifibrotic therapy (pirfenidone or nintedanib) at least 3 months
- No changes in other medication for at least 4 wks before enrollment
- Must be able to read, write, and verbally communicate in English
Who cannot join
- Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 after administration of bronchodilator at screening
- Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
- Known explanation for interstitial lung disease
- History of asthma or chronic obstructive pulmonary disease
- Active infection
- Ongoing IPF treatments including investigational therapy, immunosuppresents (other than prednisone 20 mg daily and below) and cytokine modulating agents
Show all 11Show fewer
- Participation in a supervised exercise program including pulmonary rehab within the previous 12 months
- History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
- Major orthopedic, psychiatric, neurological, or other conditions that would impair performance of the study exercise outcomes
- Require >5LPM supplemental O2 at rest
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mobile Health Exercise Prescription to Enhance Effectiveness of Antifibrotic Therapy in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Patients with idiopathic pulmonary fibrosis (IPF) who are stable on antifibrotic therapy at least 3 months will be randomized to complete a 12-week home exercise intervention using an mHealth platform, plus a pre- and post-intervention monitoring period (4 weeks each) and in-person study assessments.
Read the detailed description
Contemporary walk test endpoints in IPF trials may under-represent patient functional gains with antifibrotic therapy, which may be more effectively captured with long-term activity monitoring. Traditional pulmonary rehabilitation centers create a barrier to patient exercise accessibility and compliance, which is eliminated in a mobile health (mHealth) exercise training approach. In this study, 30 patients with IPF will be randomized into one of two arms. The exercise arm will receive a 12-week home exercise intervention using an mHealth platform plus pre- and post-intervention monitoring (4 weeks each). The non-exercise arm will be monitored for the same study duration. The primary end point is change from baseline in daily physical activity as a number of weekly exercise minutes qualifying as moderate to vigorous physical activity (MVPA), METS*minutes of exercise per week, and sedentary time minutes. Assessments will be performed primarily via in-person study visits at week 4 and week 16, as well as via daily recordings from mHealth monitoring devices.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- 12-week mHealth home exercise prescription
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week mHealth home exercise prescriptionBehavioural
3x/week home walking protocol, 2x/week resistance exercise program
| Study group | Role | What they receive |
|---|---|---|
| Exercise Arm | Experimental | antifibrotic therapy + mHealth monitoring + 12-wk mHealth home exercise prescription Receives: Behavioral: 12-week mHealth home exercise prescription |
| Non-Exercise Arm | No intervention | antifibrotic therapy + mHealth monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Physical Activity
Daily activity as step counts, intensity (metabolic equivalents), and duration (METS*min) of activity to identify number of minutes spent in moderate-to-vigorous physical activity (MVPA) vs. sedentary time
Measured: 20 weeks
Rates of recruitment, adherence, completion and adverse events
As indicators of intervention feasibility.
Measured: 20 weeks
Secondary outcomes (11)
Oxygen Saturation (SpO2)
To monitor pulse oximetry second-by-second during exercise
Measured: 12 weeks
Cardiopulmonary Exercise Testing (CPET)
To assess for peak oxygen consumption, peak watts, and time to peak, resting/ peak/recovery heart rate, resting and exercise SpO2, and other variables
Measured: Week 4, Week 16
Pulmonary Function Tests (PFT) with DLCO
To assess lung volumes and capacities indicative of pulmonary function
Measured: Week 4, Week 16
Six Minute Walk Test (6MWT)
To assess walking distance and oxygen desaturation during submaximal exercise
Measured: Week 4, Week 16
Seated Knee Extension Maximal Force and Fatigue Curve Test
With computerized dynamometer (Noraxon)
Measured: Week 4, Week 16
Lower Extremity Power Test
With computerized dynamometer and interfacing force platform (Noraxon)
Measured: Week 4, Week 16
Wall Squat Functional Strength Test
Functional strength testing of the lower extremities
Measured: Week 4, Week 16
Borg Rating of Perceived Dyspnea Scale
Survey dyspnea at rest and during exertion on a likert scale, with a range of 0-10. Higher scores indicate more severe shortness of breath.
Measured: 20 weeks
IPF-specific version of the St. George Respiratory Questionnaire (SGRQ-I)
An idiopathic pulmonary fibrosis-specific health-related quality of life (HRQL) questionnaire. Domain and total scores are transformed to a range of 0-100, with higher scores indicating more impaired HRQL.
Measured: Week 4, Week 16, Week 20
King's Brief Interstitial Lung Disease (KBILD) Questionnaire
An interstitial lung disease-specific, health-related quality of life (HRQL) questionnaire. KBILD domain and total scores are transformed to a range of 0-100. Higher scores indicate less impaired HRQL. A score of 100 = best health state.
Measured: Week 4, Week 16, Week 20
Plasma brain natriuretic peptide (BNP)
An indicator of cardiac wall stress
Measured: Week 4, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 May 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Mary Beth Brown, University of Washington
- Investigators
- Mary Beth Brown, PT, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838275
- Sponsor's protocol ID
- STUDY00012537
- Status last verified
- Jul 2025
- First submitted
- 5 Apr 2021
- Last updated
- 24 Jul 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Exercise Prescription to Enhance Effectiveness of Antifibrotic Therapy in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT04838275
- Acronym / sponsor ID
- STUDY00012537
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Apr 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.
Patients with idiopathic pulmonary fibrosis (IPF) who are stable on antifibrotic therapy at least 3 months will be randomized to complete a 12-week home exercise intervention using an mHealth platform, plus a pre- and post-intervention monitoring period (4 weeks each) and in-person study assessments.
Detailed description
Contemporary walk test endpoints in IPF trials may under-represent patient functional gains with antifibrotic therapy, which may be more effectively captured with long-term activity monitoring. Traditional pulmonary rehabilitation centers create a barrier to patient exercise accessibility and compliance, which is eliminated in a mobile health (mHealth) exercise training approach. In this study, 30 patients with IPF will be randomized into one of two arms. The exercise arm will receive a 12-week home exercise intervention using an mHealth platform plus pre- and post-intervention monitoring (4 weeks each). The non-exercise arm will be monitored for the same study duration. The primary end point is change from baseline in daily physical activity as a number of weekly exercise minutes qualifying as moderate to vigorous physical activity (MVPA), METS*minutes of exercise per week, and sedentary time minutes. Assessments will be performed primarily via in-person study visits at week 4 and week 16, as well as via daily recordings from mHealth monitoring devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Arm | Experimental | Behavioral: 12-week mHealth home exercise prescriptionantifibrotic therapy + mHealth monitoring + 12-wk mHealth home exercise prescription |
| Non-Exercise Arm | No intervention | –antifibrotic therapy + mHealth monitoring |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 40-80 yrs at randomization
- Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2018 Guidelines
- Percent Forced Vital Capacity (%FVC) ≥50%
- Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30%
- Willing and able to participate in an exercise regimen
Key exclusion criteria (11 listed)
- Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 after administration of bronchodilator at screening
- Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
- Known explanation for interstitial lung disease
- History of asthma or chronic obstructive pulmonary disease
- Active infection
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 |
|---|---|---|
| 12-week mHealth home exercise prescription3x/week home walking protocol, 2x/week resistance exercise program | Behavioural | Exercise Arm |
Primary outcome
Daily Physical Activity
Time frame: 20 weeks
Daily activity as step counts, intensity (metabolic equivalents), and duration (METS*min) of activity to identify number of minutes spent in moderate-to-vigorous physical activity (MVPA) vs. sedentary time
Rates of recruitment, adherence, completion and adverse events
Time frame: 20 weeks
As indicators of intervention feasibility.
11 secondary outcomes
Oxygen Saturation (SpO2)
Time frame: 12 weeks
Cardiopulmonary Exercise Testing (CPET)
Time frame: Week 4, Week 16
Pulmonary Function Tests (PFT) with DLCO
Time frame: Week 4, Week 16
Six Minute Walk Test (6MWT)
Time frame: Week 4, Week 16
Seated Knee Extension Maximal Force and Fatigue Curve Test
Time frame: Week 4, Week 16
Lower Extremity Power Test
Time frame: Week 4, Week 16
Wall Squat Functional Strength Test
Time frame: Week 4, Week 16
Borg Rating of Perceived Dyspnea Scale
Time frame: 20 weeks
IPF-specific version of the St. George Respiratory Questionnaire (SGRQ-I)
Time frame: Week 4, Week 16, Week 20
King's Brief Interstitial Lung Disease (KBILD) Questionnaire
Time frame: Week 4, Week 16, Week 20
Plasma brain natriuretic peptide (BNP)
Time frame: Week 4, Week 16
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 24 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis
Not yet recruitingPhase 3
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Pulmonary Fibrosis
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic 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. This study is not recruiting at the moment.
Mary Beth Brown, PT, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week mHealth home exercise prescription in people with Idiopathic Pulmonary Fibrosis, run by University of Washington 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 9 inclusion and 11 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 24 Jul 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?
Daily Physical Activity (time frame: 20 weeks). 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 24 Jul 2025.