IPF mHealth Exercise
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exercise Arm antifibrotic therapy + mHealth monitoring + 12-wk mHealth home exercise prescription |
Behavioral: 12-week mHealth home exercise prescription
3x/week home walking protocol, 2x/week resistance exercise program
|
| No Intervention: Non-Exercise Arm antifibrotic therapy + mHealth monitoring |
Outcome Measures
Primary Outcome Measures
- 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
Secondary Outcome Measures
- Oxygen Saturation (SpO2) [12 weeks]
To monitor pulse oximetry second-by-second during exercise
- 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
- 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)
- Wall Squat Functional Strength Test [Week 4, Week 16]
Functional strength testing of the lower extremities
- 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.
Eligibility Criteria
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%
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Willing and able to participate in an exercise regimen
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Ambulatory without the use of an assistive device
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Stable on antifibrotic therapy (pirfenidone or nintedanib) at least 3 months
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No changes in other medication for at least 4 wks before enrollment
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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
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Known explanation for interstitial lung disease
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History of asthma or chronic obstructive pulmonary disease
-
Active infection
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Ongoing IPF treatments including investigational therapy, immunosuppresents (other than prednisone 20 mg daily and below) and cytokine modulating agents
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Participation in a supervised exercise program including pulmonary rehab within the previous 12 months
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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
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Require >5LPM supplemental O2 at rest
-
Currently pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Washington | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- University of Washington
- Genentech, Inc.
Investigators
- Principal Investigator: Mary Beth Brown, PT, PhD, University of Washington
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00012537