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

NCT06751069 | Recruiting DMC

• 1 other identifier: 24-007966
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 4

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.

Conditions

Lung Fibrosis; Lung Interstitial Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Modified Medical Research Council (mMRC)

  Baseline, end of intervention (3 months), and 3 months post-intervention

• Living with Pulmonary Fibrosis (L-PF)-Symptoms and Impacts Questionnaire

  Baseline, end of intervention (3 months), and 3 months post-intervention

• FACIT Fatigue Scale

  Baseline, end of intervention (3 months), and 3 months post-intervention

• Leicester Cough Questionnaire (LCQ)

  Baseline, end of intervention (3 months), and 3 months post-intervention

Other Outcomes (1)

• Healthcare Utilization

  Six months prior to enrollment, end of intervention (3 months), and 3 months post-intervention

Study Arms (2)

Home-based Pulmonary Rehabilitation with Health Coaching Group

EXPERIMENTAL

Twelve-week intervention with home-based pulmonary rehabilitation and health coaching.

Behavioral: Home-based Pulmonary Rehab

Non-use Waitlist Control Observation Group

NO INTERVENTION

12-week non-use usual care waitlist with transition to intervention group at the end of the observation period.

Interventions

Home-based Pulmonary Rehab BEHAVIORAL

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.

Home-based Pulmonary Rehabilitation with Health Coaching Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (4)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Teng Moua

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Hoult, MS

CONTACT

507-293-1989; hoult.johanna@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized waitlist control

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)