Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease

Not Applicable

• Conditions: Fibrotic Interstitial Lung Disease
• Interventions: Behavioral: Home-based pulmonary rehabilitation

• Registration Number: NCT05130034
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Study Start: 2022-02-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home-based pulmonary rehab for fibrotic interstitial lung disease	Home-based pulmonary rehabilitation	Subjects diagnosed with fibrotic interstitial lung disease will participate in a home-rehab program that promotes more physical activity in daily life.

Primary Outcome Measures

Name	Time	Method
Physical activity	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	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	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 Outcome Measures

Name	Time	Method
Self-reported tolerance of directed medical management	Baseline, 12 weeks	Pre and post-intervention assessment of patient-reported side-effect severity from medical management
Qualitative assessment of patient-reported efficacy	12 weeks	Measured at the end of study through qualitative interviews using structured interview guide, combined with primary outcomes using mixed-methods analysis. Potential themes of relevance being sought include changes in patient perception of disease severity, overcoming emotional and physical burden of disease, and feasibility and long-term utility of the intervention.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States