Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Home-based Pulmonary Rehab
BehavioralParticipants 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.
Treatment groups
460 Participants
are divided into 2 treatment groupsGroup A: Home-based Pulmonary Rehabilitation with Health Coaching GroupExperimental treatment 1 intervention
Group B: Non-use Waitlist Control Observation GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
King's Brief Interstitial Lung Disease (K- BILD)
Respiratory-related quality of life questionnaire
Time frame
Baseline, end of intervention (3 months), and 3 months post-intervention2
Physical activity as measured by change in mean number of steps per day
Mean number of steps as measured by Actigraph monitor over 5-7 days
Time frame
Baseline, end of intervention (3 months), and 3 months post-interventionSecondary outcomes
1
Modified Medical Research Council (mMRC)
dyspnea scale
Time frame
Baseline, end of intervention (3 months), and 3 months post-intervention2
Living with Pulmonary Fibrosis (L-PF)-Symptoms and Impacts Questionnaire
Respiratory-related quality of life questionnaire
Time frame
Baseline, end of intervention (3 months), and 3 months post-intervention3
FACIT Fatigue Scale
Fatigue assessment questionnaire
Time frame
Baseline, end of intervention (3 months), and 3 months post-intervention4
Leicester Cough Questionnaire (LCQ)
Cough severity assessment questionnaire
Time frame
Baseline, end of intervention (3 months), and 3 months post-interventionOther outcomes
1
Healthcare Utilization
Interval clinical status as reported or assessed in the medical record for clinic, urgent, emergency room visits, and hospitalizations, for all causes
Time frame
Six months prior to enrollment, end of intervention (3 months), and 3 months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov