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

Last updated: March 10, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Cystic Fibrosis

Pulmonary Fibrosis

Treatment

Home-based Pulmonary Rehab

Clinical Study ID

NCT06751069
24-007966
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 (professionaltranslators will be engaged to support screening, enrollment, and studyparticipation)

Exclusion

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

Total Participants: 460
Treatment Group(s): 1
Primary Treatment: Home-based Pulmonary Rehab
Phase:
Study Start date:
March 03, 2025
Estimated Completion Date:
September 30, 2030

Study 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.

Connect with a study center

  • Mayo Clinic in Arizona

    Scottsdale, Arizona 85259
    United States

    Active - Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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