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

Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial

The purpose of this clinical trial is to determine the impact of a home-based pulmonary rehabilitation program with health coaching on patient-reported respiratory-related quality of life and physical activity, as compared to usual care in patients with fibrotic interstitial lung disease.

Study Overview

• Status: Recruiting
• Conditions: Lung Fibrosis; Lung Interstitial Disease
• Intervention / Treatment: Behavioral: Home-based Pulmonary Rehab

Detailed Description

The fibrotic interstitial lung diseases (f-ILD) are a group of progressive and debilitating lung diseases sharing characteristics of lung scarring on imaging and restricted breathing on pulmonary function testing (PFT). Symptoms include shortness of breath, cough, and fatigue, eventually leading to deconditioning and poor quality of life. While medical therapies are available for slowing or stopping the loss of lung function, only pulmonary rehabilitation (PR) has shown a positive impact on patient-reported shortness of breath and physical activity. Unfortunately, PR may not be widely available to all patients, and some patients may become too ill to participate in traditional center-based programs.

A primary hypothesis is that modifying the content, delivery, and setting for PR in patients with f-ILD to improve access or ease of use and supporting behavior change through a health coach will have a measurable and sustained positive impact on patient well-being and quality of life as compared to no participation or non-use.

• Study Type: Interventional
• Enrollment (Estimated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johanna Hoult, MS; Phone Number: 507-293-1989; Email: hoult.johanna@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Principal Investigator: Ana Zamora Martinez, MD
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
      • Principal Investigator: Hassan Z Baig, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Principal Investigator: Hyun Kim, MD
      • Contact: Scott Rajala; Phone Number: 612-624-8511; Email: srajala@umn.edu
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Teng Moua, MD
      • Contact: Johanna Hoult, MS; Phone Number: 507-293-1989; Email: hoult.johanna@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

IInclusion Criteria:

• F-ILD diagnosis, any disease subtype, active or prior medical treatment
• >10% fibrosis on CT imaging
• mMRC dyspnea score >1
• All racial or ethnic categories, including non-English speakers (professional translators will be engaged to support screening, enrollment, and study participation)

Exclusion Criteria:

• Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
• Cognitive impairment or inability to understand and follow instructions
• Traditional center-based PR completed within 3 months of initial study recruitment
• Transition to 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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based Pulmonary Rehabilitation with Health Coaching Group; Twelve-week intervention with home-based pulmonary rehabilitation and health coaching.	Behavioral: Home-based Pulmonary Rehab; Participants are expected to engage in the home-based PR routine five to six days a week for the entire 12-week study period. The PR routine begins with slow upper body and timed breathing exercises, followed by two slow balance walks for 6 minutes each. The total exercise time is 24 minutes a day followed by a 4-minute mindful breathing meditation/cool down. Exercises may be modified or repeated according to baseline activity level and as conditioning improves.
No Intervention: Non-use Waitlist Control Observation Group; 12-week non-use usual care waitlist with transition to intervention group at the end of the observation period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
King's Brief Interstitial Lung Disease (K- BILD)	Respiratory-related quality of life questionnaire	Baseline, end of intervention (3 months), and 3 months post-intervention
Physical activity as measured by change in mean number of steps per day	Mean number of steps as measured by Actigraph monitor over 5-7 days	Baseline, end of intervention (3 months), and 3 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Medical Research Council (mMRC)	dyspnea scale	Baseline, end of intervention (3 months), and 3 months post-intervention
Living with Pulmonary Fibrosis (L-PF)-Symptoms and Impacts Questionnaire	Respiratory-related quality of life questionnaire	Baseline, end of intervention (3 months), and 3 months post-intervention
FACIT Fatigue Scale	Fatigue assessment questionnaire	Baseline, end of intervention (3 months), and 3 months post-intervention
Leicester Cough Questionnaire (LCQ)	Cough severity assessment questionnaire	Baseline, end of intervention (3 months), and 3 months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Utilization	Interval clinical status as reported or assessed in the medical record for clinic, urgent, emergency room visits, and hospitalizations, for all causes	Six months prior to enrollment, end of intervention (3 months), and 3 months post-intervention

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Teng Moua, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: 24-007966

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
• product manufactured in and exported from the U.S.: No