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Completed

NCT Number: NCT05130034

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

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).

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Key information

Conditions

Fibrotic Interstitial Lung Disease

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-based pulmonary rehabilitation

Behavioral

Home-based tablet-assisted pulmonary rehabilitation with monitoring technology and telephonic health coach calls using motivational interviewing techniques

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. Qualitative assessment of patient-reported efficacy

    Time frame: 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.

  2. Self-reported tolerance of directed medical management

    Time frame: Baseline, 12 weeks

    Pre and post-intervention assessment of patient-reported side-effect severity from medical management

Other outcomes

  1. Change in self-management ability

    Time frame: Baseline, 12 weeks

    Assessed pre and post-intervention using SMAS-30, a validated questionnaire highlighting six core self-management abilities including taking initiative, investment behavior, variety, multi-functionality, self-efficacy, and positive frame of mind. Higher total or domain scores suggest higher relative self-management ability.

  2. Change in mood or affect

    Time frame: Baseline, 12 weeks

    Assessed pre and post-intervention using Positive and Negative Affect Scale (PANAS), a 20-item scale measures the positive and negative affective components of well-being. A ratio of 2.5 or higher for positive vs negative assessments suggests more positive mood.

  3. Change in self-reported dyspnea

    Time frame: Baseline, 12 weeks

    Assessed pre and post-intervention using Modified Medical Research Council (mMRC) scale; a change in 1 point is the minimal clinically important difference (MCID), with HIGHER scores suggesting greater dyspnea.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

Home-based Pulmonary Rehabilitation and Health Coaching to Improve Respiratory-related Quality of Life and Physical Activity in Fibrotic Interstitial Lung Disease

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2021
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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