What this study is
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.
What's being tested
- Home-based Pulmonary Rehab
Intervention · 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.
Study details
- Official title
- Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial
- Sponsor
- Mayo Clinic
- Conditions
- Lung Fibrosis · Lung Interstitial Disease
- Enrolling
- 460 people
- Starts
- 2025-03-03
- Est. completion
- 2030-09-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openMayo Clinic in Arizona
Scottsdale, Arizona, United States
- Ana Zamora Martinez, MD · Principal investigator
RecruitingMayo Clinic in Florida
Jacksonville, Florida, United States
- Hassan Z Baig, MD · Principal investigator
RecruitingUniversity of Minnesota
Minneapolis, Minnesota, United States
- Scott Rajala · Contact612-624-8511srajala@umn.edu
- Hyun Kim, MD · Principal investigator
RecruitingMayo Clinic in Rochester
Rochester, Minnesota, United States
- Johanna Hoult, MS · Contact507-293-1989hoult.johanna@mayo.edu
- Teng Moua, MD · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 24-007966
Principal investigator
Teng Moua
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.