IPF mHealth Exercise
Purpose
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.
Condition
- Idiopathic Pulmonary Fibrosis
Eligibility
- Eligible Ages
- Between 40 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age 40-80 yrs at randomization - Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2018 Guidelines - Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% - Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% - Willing and able to participate in an exercise regimen - Ambulatory without the use of an assistive device - 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
Exclusion Criteria
- 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 - 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Exercise Arm |
antifibrotic therapy + mHealth monitoring + 12-wk mHealth home exercise prescription |
|
|
No Intervention Non-Exercise Arm |
antifibrotic therapy + mHealth monitoring |
|
Recruiting Locations
Seattle, Washington 98195
More Details
- NCT ID
- NCT04838275
- Status
- Recruiting
- Sponsor
- University of Washington
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.