IPF mHealth Exercise

Not Applicable

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Behavioral: 12-week mHealth home exercise prescription

• Registration Number: NCT04838275
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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%
• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise Arm	12-week mHealth home exercise prescription	antifibrotic therapy + mHealth monitoring + 12-wk mHealth home exercise prescription

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Seated Knee Extension Maximal Force and Fatigue Curve Test	Week 4, Week 16	With computerized dynamometer (Noraxon)
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
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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States