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

NCT ID: NCT06751069

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2030-09-30

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.

Conditions

Lung Fibrosis; Lung Interstitial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home-based Pulmonary Rehabilitation with Health Coaching Group

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

Group Type: EXPERIMENTAL

Home-based Pulmonary Rehab

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Teng Moua

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teng Moua

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status: RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Johanna Hoult, MS

Role: CONTACT

hoult.johanna@mayo.edu

507-293-1989

Facility Contacts

Johanna Hoult, MS

Role: primary

hoult.johanna@mayo.edu

507-293-1989

Other Identifiers

24-007966

Identifier Type: -

Identifier Source: org_study_id