Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease

Home-based Pulmonary Rehabilitation and Health Coaching to Improve Respiratory-related Quality of Life and Physical Activity in Fibrotic Interstitial Lung Disease

The purpose of this study is to gather information on the effectiveness of a home-based pulmonary rehabilitation program with health coaching and tele-monitoring for improving patient-reported respiratory-related quality of life and physical activity in patients with fibrotic Interstitial Lung Diseases (f-ILD).

Study Overview

• Status: Completed
• Conditions: Fibrotic Interstitial Lung Disease
• Intervention / Treatment: Behavioral: Home-based pulmonary rehabilitation

Detailed Description

The home-based pulmonary rehabilitation program involves using a computer tablet paired with a pulse oximeter and activity tracker. Gentle upper body exercises, walking and a breathing practice are completed by following along on the computer tablet. Weekly check-in calls by telephone will be provided by a Health Coach to assess clinical status and monitor progress. The exercise portion of the program lasts 12 weeks. There are questionnaires and a research grade activity tracker measuring baseline and post-intervention findings at the end of 12-week period.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of idiopathic pulmonary fibrosis (IPF) or other fibrotic interstitial lung disease, with a minimum of > 10% fibrosis on computed tomography imaging.
• Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score >1.

Exclusion Criteria:

• Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
• Cognitive impairment or inability to understand and follow instructions.
• Traditional PR completed within 3 months of study recruitment.
• Hospice or end-of-life care at the time of screening.
• Acute exacerbation at the time of screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based pulmonary rehab for fibrotic interstitial lung disease; Subjects diagnosed with fibrotic interstitial lung disease will participate in a home-rehab program that promotes more physical activity in daily life.	Behavioral: Home-based pulmonary rehabilitation; Home-based tablet-assisted pulmonary rehabilitation with monitoring technology and telephonic health coach calls using motivational interviewing techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient-reported respiratory-related quality of life CRQ Physical Summary score	Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The Physical Summary score combines dyspnea and fatigue dimensions, a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.	Baseline, 12 weeks
Change in patient-reported respiratory-related quality of life CRQ Emotional score	Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The emotional domain score is measured by a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.	Baseline, 12 weeks
Physical activity	Measured by mean number of steps per 24-hour period as assessed by Actigraphy, pre- and post-intervention	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment of patient-reported efficacy	Measured at the end of study through qualitative interviews using structured interview guide, combined with primary outcomes using mixed-methods analysis. Potential themes of relevance being sought include changes in patient perception of disease severity, overcoming emotional and physical burden of disease, and feasibility and long-term utility of the intervention.	12 weeks
Self-reported tolerance of directed medical management	Pre and post-intervention assessment of patient-reported side-effect severity from medical management	Baseline, 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-management ability	Assessed pre and post-intervention using SMAS-30, a validated questionnaire highlighting six core self-management abilities including taking initiative, investment behavior, variety, multi-functionality, self-efficacy, and positive frame of mind. Higher total or domain scores suggest higher relative self-management ability.	Baseline, 12 weeks
Change in mood or affect	Assessed pre and post-intervention using Positive and Negative Affect Scale (PANAS), a 20-item scale measures the positive and negative affective components of well-being. A ratio of 2.5 or higher for positive vs negative assessments suggests more positive mood.	Baseline, 12 weeks
Change in self-reported dyspnea	Assessed pre and post-intervention using Modified Medical Research Council (mMRC) scale; a change in 1 point is the minimal clinically important difference (MCID), with HIGHER scores suggesting greater dyspnea.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Teng Moua, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 21-006804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No