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

NCT ID: NCT05130034

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2025-04-15

Brief Summary

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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

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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.

Conditions

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Fibrotic Interstitial Lung Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Home-based pulmonary rehab for fibrotic interstitial lung disease

Subjects diagnosed with fibrotic interstitial lung disease will participate in a home-rehab program that promotes more physical activity in daily life.

Group Type EXPERIMENTAL

Home-based pulmonary rehabilitation

Intervention Type BEHAVIORAL

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

Interventions

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Home-based pulmonary rehabilitation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Teng Moua

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Teng Moua, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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21-006804

Identifier Type: -

Identifier Source: org_study_id

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