IPF mHealth Exercise

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04838275
• Other study ID #: STUDY00012537
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Washington
• Contact: Beth Brown, PT, PhD
• Phone: 206-685-3852
• Email: mbbrown1[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Behavioral:
• 12-week mHealth home exercise prescription
3x/week home walking protocol, 2x/week resistance exercise program

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Oxygen Saturation (SpO2)	To monitor pulse oximetry second-by-second during exercise	12 weeks
Secondary	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
Secondary	Pulmonary Function Tests (PFT) with DLCO	To assess lung volumes and capacities indicative of pulmonary function	Week 4, Week 16
Secondary	Six Minute Walk Test (6MWT)	To assess walking distance and oxygen desaturation during submaximal exercise	Week 4, Week 16
Secondary	Seated Knee Extension Maximal Force and Fatigue Curve Test	With computerized dynamometer (Noraxon)	Week 4, Week 16
Secondary	Lower Extremity Power Test	With computerized dynamometer and interfacing force platform (Noraxon)	Week 4, Week 16
Secondary	Wall Squat Functional Strength Test	Functional strength testing of the lower extremities	Week 4, Week 16
Secondary	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
Secondary	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
Secondary	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