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

Not Applicable

Recruiting

• Conditions: Lung Fibrosis; Lung Interstitial Disease

• Registration Number: NCT06751069
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-27
• Status Verified: 2025-03
• Study Start: 2025-03-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2030-07-01
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

Inclusion 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States