Clinical trial NCT04838275: IPF mHealth Exercise Study
Official title: A Mobile Health Exercise Prescription to Enhance Effectiveness of Antifibrotic Therapy in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2021-04-09
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily Physical Activity
timeFrame: 20 weeks
Secondary outcomes:
measure: Oxygen Saturation (SpO2)
timeFrame: 12 weeks
measure: Cardiopulmonary Exercise Testing (CPET)
timeFrame: Week 4, Week 16
measure: Pulmonary Function Tests (PFT) with DLCO
timeFrame: Week 4, Week 16
measure: Six Minute Walk Test (6MWT)
timeFrame: Week 4, Week 16
measure: Seated Knee Extension Maximal Force and Fatigue Curve Test
timeFrame: Week 4, Week 16
measure: Lower Extremity Power Test
timeFrame: Week 4, Week 16
measure: Wall Squat Functional Strength Test
timeFrame: Week 4, Week 16
measure: Borg Rating of Perceived Dyspnea Scale
timeFrame: 20 weeks
measure: IPF-specific version of the St. George Respiratory Questionnaire (SGRQ-I)
timeFrame: Week 4, Week 16, Week 20
measure: King's Brief Interstitial Lung Disease (KBILD) Questionnaire
timeFrame: Week 4, Week 16, Week 20
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Mary Beth Brown, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: