Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06751069

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. King's Brief Interstitial Lung Disease (K- BILD)

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

    Respiratory-related quality of life questionnaire

  2. Physical activity as measured by change in mean number of steps per day

    Time frame: 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 outcomes

  1. Modified Medical Research Council (mMRC)

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

    dyspnea scale

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

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

    Respiratory-related quality of life questionnaire

  3. FACIT Fatigue Scale

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

    Fatigue assessment questionnaire

  4. Leicester Cough Questionnaire (LCQ)

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

    Cough severity assessment questionnaire

Other outcomes

  1. Healthcare Utilization

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

    Interval clinical status as reported or assessed in the medical record for clinic, urgent, emergency room visits, and hospitalizations, for all causes

Study contacts

Contact information is provided by the study sponsor or research team.

Johanna Hoult, MS

CONTACT

[email protected]

507-293-1989

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 27, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.