IPF mHealth Exercise Study

NCT04838275 | Completed

• 1 other identifier: STUDY00012537
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Oxygen Saturation (SpO2)

  12 weeks

• Cardiopulmonary Exercise Testing (CPET)

  Week 4, Week 16

• Pulmonary Function Tests (PFT) with DLCO

  Week 4, Week 16

• Six Minute Walk Test (6MWT)

  Week 4, Week 16

• Seated Knee Extension Maximal Force and Fatigue Curve Test

  Week 4, Week 16

Study Arms (2)

Exercise Arm

EXPERIMENTAL

antifibrotic therapy + mHealth monitoring + 12-wk mHealth home exercise prescription

Behavioral: 12-week mHealth home exercise prescription

Non-Exercise Arm

NO INTERVENTION

antifibrotic therapy + mHealth monitoring

Interventions

12-week mHealth home exercise prescription BEHAVIORAL

3x/week home walking protocol, 2x/week resistance exercise program

Exercise Arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mary Beth Brown, PT, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 9, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)