IPF mHealth Exercise

Study Overview
=================
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.

Official Title
-----------------
A Mobile Health Exercise Prescription to Enhance Effectiveness of Antifibrotic Therapy in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Behavioral: 12-week mHealth home exercise prescription


Participation Criteria
=================
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% 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Arm<br>antifibrotic therapy + mHealth monitoring + 12-wk mHealth home exercise prescription | Behavioral: 12-week mHealth home exercise prescription<br>* 3x/week home walking protocol, 2x/week resistance exercise program<br>|
| No Intervention: Non-Exercise Arm<br>antifibrotic therapy + mHealth monitoring | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |