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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
3x/week home walking protocol, 2x/week resistance exercise program
University of Washington
Seattle, Washington, United States
Daily Physical Activity
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
Time frame: 20 weeks
Rates of recruitment, adherence, completion and adverse events
As indicators of intervention feasibility.
Time frame: 20 weeks
Oxygen Saturation (SpO2)
To monitor pulse oximetry second-by-second during exercise
Time frame: 12 weeks
Cardiopulmonary Exercise Testing (CPET)
To assess for peak oxygen consumption, peak watts, and time to peak, resting/ peak/recovery heart rate, resting and exercise SpO2, and other variables
Time frame: Week 4, Week 16
Pulmonary Function Tests (PFT) with DLCO
To assess lung volumes and capacities indicative of pulmonary function
Time frame: Week 4, Week 16
Six Minute Walk Test (6MWT)
To assess walking distance and oxygen desaturation during submaximal exercise
Time frame: Week 4, Week 16
Seated Knee Extension Maximal Force and Fatigue Curve Test
With computerized dynamometer (Noraxon)
Time frame: Week 4, Week 16
Lower Extremity Power Test
With computerized dynamometer and interfacing force platform (Noraxon)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 4, Week 16
Wall Squat Functional Strength Test
Functional strength testing of the lower extremities
Time frame: Week 4, Week 16
Borg Rating of Perceived Dyspnea Scale
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.
Time frame: 20 weeks
IPF-specific version of the St. George Respiratory Questionnaire (SGRQ-I)
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.
Time frame: Week 4, Week 16, Week 20
King's Brief Interstitial Lung Disease (KBILD) Questionnaire
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.
Time frame: Week 4, Week 16, Week 20
Plasma brain natriuretic peptide (BNP)
An indicator of cardiac wall stress
Time frame: Week 4, Week 16