Clinical trial NCT05130034: Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease
Official title: Home-based Pulmonary Rehabilitation and Health Coaching to Improve Respiratory-related Quality of Life and Physical Activity in Fibrotic Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibrotic Interstitial Lung Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2021-11-22
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to gather information on the effectiveness of a home-based pulmonary rehabilitation program with health coaching and tele-monitoring for improving patient-reported respiratory-related quality of life and physical activity in patients with fibrotic Interstitial Lung Diseases (f-ILD).

Detailed description: The home-based pulmonary rehabilitation program involves using a computer tablet paired with a pulse oximeter and activity tracker. Gentle upper body exercises, walking and a breathing practice are completed by following along on the computer tablet. Weekly check-in calls by telephone will be provided by a Health Coach to assess clinical status and monitor progress. The exercise portion of the program lasts 12 weeks. There are questionnaires and a research grade activity tracker measuring baseline and post-intervention findings at the end of 12-week period.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic pulmonary fibrosis (IPF) or other fibrotic interstitial lung disease, with a minimum of \> 10% fibrosis on computed tomography imaging.
* Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score \>1.

Exclusion Criteria:

* Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
* Cognitive impairment or inability to understand and follow instructions.
* Traditional PR completed within 3 months of study recruitment.
* Hospice or end-of-life care at the time of screening.
* Acute exacerbation at the time of screening.

Primary outcomes:
measure: Change in patient-reported respiratory-related quality of life CRQ Physical Summary score
timeFrame: Baseline, 12 weeks
measure: Change in patient-reported respiratory-related quality of life CRQ Emotional score
timeFrame: Baseline, 12 weeks
measure: Physical activity
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Qualitative assessment of patient-reported efficacy
timeFrame: 12 weeks
measure: Self-reported tolerance of directed medical management
timeFrame: Baseline, 12 weeks
Other outcomes:
measure: Change in self-management ability
timeFrame: Baseline, 12 weeks
measure: Change in mood or affect
timeFrame: Baseline, 12 weeks
measure: Change in self-reported dyspnea
timeFrame: Baseline, 12 weeks
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Teng Moua, MD
role: PRINCIPAL_INVESTIGATOR
References: