Status:
COMPLETED
IPF mHealth Exercise Study
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief 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...
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. Tradit...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04838275
Start Date
May 1 2021
End Date
December 31 2024
Last Update
July 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Washington
Seattle, Washington, United States, 98195