Home-based Pulmonary Rehabilitation and Health Coaching to Improve Respiratory-related Quality of Life and Physical Activity in Fibrotic Interstitial Lung Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fibrotic Interstitial Lung Disease
- Sponsor
- Mayo Clinic
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Physical activity
- Status
- Completed
- Last Updated
- 12 months ago
Overview
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.
Investigators
Teng Moua
Principal Investigator
Mayo Clinic
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.
Outcomes
Primary Outcomes
Physical activity
Time Frame: Baseline, 12 weeks
Measured by mean number of steps per 24-hour period as assessed by Actigraphy, pre- and post-intervention
Change in patient-reported respiratory-related quality of life CRQ Physical Summary score
Time Frame: Baseline, 12 weeks
Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The Physical Summary score combines dyspnea and fatigue dimensions, a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.
Change in patient-reported respiratory-related quality of life CRQ Emotional score
Time Frame: Baseline, 12 weeks
Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The emotional domain score is measured by a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.
Secondary Outcomes
- Self-reported tolerance of directed medical management(Baseline, 12 weeks)
- Qualitative assessment of patient-reported efficacy(12 weeks)