IPF mHealth Exercise

  • STATUS
    Recruiting
  • days left to enroll
    55
  • participants needed
    30
  • sponsor
    University of Washington
Updated on 18 October 2021
carbon monoxide
nintedanib
a 12
idiopathic pulmonary fibrosis
pirfenidone
forced vital capacity
carbon monoxide diffusing capacity
diffusion capacity of the lung for carbon monoxide

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.

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.

Details
Condition Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, usual interstitial pneumonia
Treatment 12-week mHealth home exercise prescription
Clinical Study IdentifierNCT04838275
SponsorUniversity of Washington
Last Modified on18 October 2021

Eligibility

Yes No Not Sure

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
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