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Home-Based Pulmonary Rehabilitation for Interstitial Lung Disease

N/A

Recruiting

Led By Teng Moua, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score >1.

Diagnosis of idiopathic pulmonary fibrosis (IPF) or other fibrotic interstitial lung disease, with a minimum of > 10% fibrosis on computed tomography imaging.

Must not have

Acute exacerbation at the time of screening.

Cognitive impairment or inability to understand and follow instructions.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand whether a home-based pulmonary rehabilitation program can improve quality of life for people with f-ILD.

Who is the study for?

This trial is for people with a type of lung scarring called fibrotic Interstitial Lung Diseases who feel significantly short of breath. They must have at least 10% lung fibrosis visible on CT scans and be able to understand the study's instructions. It's not for those who've recently done pulmonary rehab, are in hospice care, currently experiencing a flare-up of symptoms, or can't walk due to other health issues.

What is being tested?

The study tests if doing pulmonary rehabilitation at home with health coaching and monitoring through technology can improve how patients with lung scarring diseases feel about their breathing and increase their physical activity.

What are the potential side effects?

Since this intervention involves exercise and lifestyle changes rather than medication, side effects may include muscle soreness or fatigue from increased physical activity. Health coaching is unlikely to cause direct side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I often feel short of breath doing daily activities.

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I have been diagnosed with a lung scarring disease with more than 10% fibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is worsening right now.

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I can understand and follow instructions.

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I cannot walk due to a physical condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in patient-reported respiratory-related quality of life CRQ Emotional score

Change in patient-reported respiratory-related quality of life CRQ Physical Summary score

Physical activity

Secondary study objectives

Qualitative assessment of patient-reported efficacy

Self-reported tolerance of directed medical management

Other study objectives

Change in mood or affect

Change in self-management ability

Change in self-reported dyspnea

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Home-based pulmonary rehab for fibrotic interstitial lung diseaseExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Home-based pulmonary rehabilitation

2015

Completed Phase 3

~240

0 / 5Eligibility criteria met