IPF mHealth Exercise Study

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.

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.

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%
• 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 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