Clinical Trials Directory

Trials / Completed

CompletedNCT04838275

IPF mHealth Exercise Study

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
40 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORAL12-week mHealth home exercise prescription3x/week home walking protocol, 2x/week resistance exercise program

Timeline

Start date
2021-05-01
Primary completion
2023-12-31
Completion
2024-12-31
First posted
2021-04-09
Last updated
2025-07-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04838275. Inclusion in this directory is not an endorsement.