Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home-based Pulmonary Rehab.
- Who it may be relevant to
- Registry conditions: Lung Fibrosis, Lung Interstitial Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial
Overview
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.
Interventions
- Behavioral 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 measures
- 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]
Secondary outcome measures (4)
- Modified Medical Research Council (mMRC) [Time frame: Baseline, end of intervention (3 months), and 3 months post-intervention]
- Living with Pulmonary Fibrosis (L-PF)-Symptoms and Impacts Questionnaire [Time frame: Baseline, end of intervention (3 months), and 3 months post-intervention]
- FACIT Fatigue Scale [Time frame: Baseline, end of intervention (3 months), and 3 months post-intervention]
- Leicester Cough Questionnaire (LCQ) [Time frame: Baseline, end of intervention (3 months), and 3 months post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Mayo Clinic in Arizona — Scottsdale
- Mayo Clinic in Florida — Jacksonville
- University of Minnesota — Minneapolis
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06751069 · 24-007966