Idiopathic Pulmonary Fibrosis
Conditions
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.
Interventions
BEHAVIORAL12-week mHealth home exercise prescription
3x/week home walking protocol, 2x/week resistance exercise program
Sponsors
Genentech, Inc.
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
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% * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Physical Activity | 20 weeks | Daily activity as step counts, intensity (metabolic equivalents), and duration (METS\*min) of activity to identify number of minutes spent in moderate-to-vigorous physical activity (MVPA) vs. sedentary time |
| Rates of recruitment, adherence, completion and adverse events | 20 weeks | As indicators of intervention feasibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Function Tests (PFT) with DLCO | Week 4, Week 16 | To assess lung volumes and capacities indicative of pulmonary function |
| Six Minute Walk Test (6MWT) | Week 4, Week 16 | To assess walking distance and oxygen desaturation during submaximal exercise |
| Seated Knee Extension Maximal Force and Fatigue Curve Test | Week 4, Week 16 | With computerized dynamometer (Noraxon) |
| Lower Extremity Power Test | Week 4, Week 16 | With computerized dynamometer and interfacing force platform (Noraxon) |
| Oxygen Saturation (SpO2) | 12 weeks | To monitor pulse oximetry second-by-second during exercise |
| Borg Rating of Perceived Dyspnea Scale | 20 weeks | Survey dyspnea at rest and during exertion on a likert scale, with a range of 0-10. Higher scores indicate more severe shortness of breath. |
| IPF-specific version of the St. George Respiratory Questionnaire (SGRQ-I) | Week 4, Week 16, Week 20 | An idiopathic pulmonary fibrosis-specific health-related quality of life (HRQL) questionnaire. Domain and total scores are transformed to a range of 0-100, with higher scores indicating more impaired HRQL. |
| King's Brief Interstitial Lung Disease (KBILD) Questionnaire | Week 4, Week 16, Week 20 | An interstitial lung disease-specific, health-related quality of life (HRQL) questionnaire. KBILD domain and total scores are transformed to a range of 0-100. Higher scores indicate less impaired HRQL. A score of 100 = best health state. |
| Plasma brain natriuretic peptide (BNP) | Week 4, Week 16 | An indicator of cardiac wall stress |
| Wall Squat Functional Strength Test | Week 4, Week 16 | Functional strength testing of the lower extremities |
| Cardiopulmonary Exercise Testing (CPET) | Week 4, Week 16 | To assess for peak oxygen consumption, peak watts, and time to peak, resting/ peak/recovery heart rate, resting and exercise SpO2, and other variables |
Countries
United States
Outcome results
None listed