Lung Fibrosis, Lung Interstitial Disease
Conditions
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.
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
BEHAVIORALHome-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.
Sponsors
Mayo Clinic
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized waitlist control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| King's Brief Interstitial Lung Disease (K- BILD) | Baseline, end of intervention (3 months), and 3 months post-intervention | Respiratory-related quality of life questionnaire |
| Physical activity as measured by change in mean number of steps per day | 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
| Measure | Time frame | Description |
|---|---|---|
| Modified Medical Research Council (mMRC) | Baseline, end of intervention (3 months), and 3 months post-intervention | dyspnea scale |
| Living with Pulmonary Fibrosis (L-PF)-Symptoms and Impacts Questionnaire | Baseline, end of intervention (3 months), and 3 months post-intervention | Respiratory-related quality of life questionnaire |
| FACIT Fatigue Scale | Baseline, end of intervention (3 months), and 3 months post-intervention | Fatigue assessment questionnaire |
| Leicester Cough Questionnaire (LCQ) | Baseline, end of intervention (3 months), and 3 months post-intervention | Cough severity assessment questionnaire |
Countries
United States
Contacts
CONTACTJohanna Hoult, MS
PRINCIPAL_INVESTIGATORTeng Moua
Mayo Clinic
Outcome results
None listed