Recruiting

Pulmonary Rehabilitation

Sponsor:

Mayo Clinic

Code:

NCT06751069

Conditions

Lung Fibrosis

Lung Interstitial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home-based Pulmonary Rehab

Study Details

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

Study ID

NCT06751069

Start date

Mar 3, 2025

Status verified date

Mar, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Jul 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

460 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Home-based Pulmonary Rehabilitation with Health Coaching Group

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

no intervention: 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.

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.

Primary outcome measure

  • King's Brief Interstitial Lung Disease (K- BILD) [ Time Frame: Baseline, end of intervention (3 months), and 3 months post-intervention ]
  • 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 ]

Central Contacts and Locations

Central contacts

Johanna Hoult, MS

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

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Principal Investigator:

Ana Zamora Martinez, MD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator:

Hassan Z Baig, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Scott Rajala

612-624-8511srajala@umn.edu

Principal Investigator:

Hyun Kim, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Johanna Hoult, MS

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

Principal Investigator:

Teng Moua, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-20.