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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Arm | Experimental | antifibrotic therapy + mHealth monitoring + 12-wk mHealth home exercise prescription |
|
| Non-Exercise Arm | No Intervention | antifibrotic therapy + mHealth monitoring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-week mHealth home exercise prescription | Behavioral | 3x/week home walking protocol, 2x/week resistance exercise program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 20 weeks |
| Rates of recruitment, adherence, completion and adverse events | As indicators of intervention feasibility. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation (SpO2) | To monitor pulse oximetry second-by-second during exercise | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Beth Brown, PT, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Week 4, Week 16 |
| Pulmonary Function Tests (PFT) with DLCO | To assess lung volumes and capacities indicative of pulmonary function | Week 4, Week 16 |
| Six Minute Walk Test (6MWT) | To assess walking distance and oxygen desaturation during submaximal exercise | Week 4, Week 16 |
| Seated Knee Extension Maximal Force and Fatigue Curve Test | With computerized dynamometer (Noraxon) | Week 4, Week 16 |
| Lower Extremity Power Test | With computerized dynamometer and interfacing force platform (Noraxon) | Week 4, Week 16 |
| Wall Squat Functional Strength Test | Functional strength testing of the lower extremities | 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. | 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. | 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. | Week 4, Week 16, Week 20 |
| Plasma brain natriuretic peptide (BNP) | An indicator of cardiac wall stress | Week 4, Week 16 |