IPF mHealth Exercise Study

NCT ID: NCT04838275

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-12-31

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise Arm

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

Group Type: EXPERIMENTAL

12-week mHealth home exercise prescription

Intervention Type: BEHAVIORAL

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

Non-Exercise Arm

antifibrotic therapy + mHealth monitoring

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

12-week mHealth home exercise prescription

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

Intervention Type: BEHAVIORAL

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%
• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Mary Beth Brown

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Beth Brown, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

STUDY00012537

Identifier Type: -

Identifier Source: org_study_id