IPF mHealth Exercise Study

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Behavioral: 12-week mHealth home exercise prescription

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

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
Rates of recruitment, adherence, completion and adverse events	As indicators of intervention feasibility.	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
Plasma brain natriuretic peptide (BNP)	An indicator of cardiac wall stress	Week 4, Week 16

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Mary Beth Brown, PT, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
• Other Study ID Numbers: STUDY00012537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No