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IPF mHealth Exercise

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

12-week mHealth home exercise prescription

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Arm

Non-Exercise Arm

Arm Description

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

antifibrotic therapy + mHealth monitoring

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Oxygen Saturation (SpO2)

To monitor pulse oximetry second-by-second during exercise

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

Pulmonary Function Tests (PFT) with DLCO

To assess lung volumes and capacities indicative of pulmonary function

Six Minute Walk Test (6MWT)

To assess walking distance and oxygen desaturation during submaximal exercise

Seated Knee Extension Maximal Force and Fatigue Curve Test

With computerized dynamometer (Noraxon)

Lower Extremity Power Test

With computerized dynamometer and interfacing force platform (Noraxon)

Wall Squat Functional Strength Test

Functional strength testing of the lower extremities

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.

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.

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.

Full Information

NCT ID

NCT04838275

First Posted

April 5, 2021

Last Updated

May 10, 2023

Sponsor

University of Washington

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04838275

Brief Title

IPF mHealth Exercise

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exercise Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Non-Exercise Arm

Arm Type

No Intervention

Arm Description

antifibrotic therapy + mHealth monitoring

Intervention Type

Behavioral

Intervention Name(s)

12-week mHealth home exercise prescription

Intervention Description

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

Primary Outcome Measure Information:

Title

Daily Physical Activity

Description

Time Frame

20 weeks

Secondary Outcome Measure Information:

Title

Oxygen Saturation (SpO2)

Description

To monitor pulse oximetry second-by-second during exercise

Time Frame

12 weeks

Title

Cardiopulmonary Exercise Testing (CPET)

Description

To assess for peak oxygen consumption, peak watts, and time to peak, resting/ peak/recovery heart rate, resting and exercise SpO2, and other variables

Time Frame

Week 4, Week 16

Title

Pulmonary Function Tests (PFT) with DLCO

Description

To assess lung volumes and capacities indicative of pulmonary function

Time Frame

Week 4, Week 16

Title

Six Minute Walk Test (6MWT)

Description

To assess walking distance and oxygen desaturation during submaximal exercise

Time Frame

Week 4, Week 16

Title

Seated Knee Extension Maximal Force and Fatigue Curve Test

Description

With computerized dynamometer (Noraxon)

Time Frame

Week 4, Week 16

Title

Lower Extremity Power Test

Description

With computerized dynamometer and interfacing force platform (Noraxon)

Time Frame

Week 4, Week 16

Title

Wall Squat Functional Strength Test

Description

Functional strength testing of the lower extremities

Time Frame

Week 4, Week 16

Title

Borg Rating of Perceived Dyspnea Scale

Description

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.

Time Frame

20 weeks

Title

IPF-specific version of the St. George Respiratory Questionnaire (SGRQ-I)

Description

Time Frame

Week 4, Week 16, Week 20

Title

King's Brief Interstitial Lung Disease (KBILD) Questionnaire

Description

Time Frame

Week 4, Week 16, Week 20

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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% 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beth Brown, PT, PhD

Phone

206-685-3852

mbbrown1@uw.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Beth Brown, PT, PhD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beth Brown, PT, PhD

Phone

206-685-3852

mbbrown1@uw.edu

First Name & Middle Initial & Last Name & Degree

Claire Child, DPT, MPH

Phone

858-395-7932

cechild@uw.edu

12. IPD Sharing Statement

Learn more about this trial

IPF mHealth Exercise

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