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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I often feel short of breath doing daily activities.
Select...
I have been diagnosed with a lung scarring disease with more than 10% fibrosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Qualitative assessment of patient-reported efficacy
Self-reported tolerance of directed medical management
Other outcome measures
Change in mood or affect
Change in self-management ability
Change in self-reported dyspnea
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
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,931 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,507 Previous Clinical Trials
11,340,827 Total Patients Enrolled
Teng Moua, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I completed my physical rehabilitation within the last 3 months.My condition is worsening right now.I often feel short of breath doing daily activities.I can understand and follow instructions.I cannot walk due to a physical condition.I have been diagnosed with a lung scarring disease with more than 10% fibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: Home-based pulmonary rehab for fibrotic interstitial lung disease
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled spots for prospective participants in this research?
"Affirmative. Clinicaltrials.gov alludes to the fact that this medical trial commenced on February 1st 2022 and is actively recruiting patients, with a target of 80 from one site."
Answered by AI
How many participants have enrolled in this trial thus far?
"Affirmative, clinicaltrials.gov indicates that this research endeavour is open for patient recruitment. Initially put up on the 1st of February 2022 and most recently updated on 11th March 2022, 80 individuals are expected to be enrolled at a single site."
Answered by AI
Who is eligible to participate in this clinical research program?
"Eligible participants must have a diagnosis of pneumonia, interstitial and fall between 18 to 95 years old. This clinical trial is specifically looking for 80 enrollees in total."
Answered by AI
Are seniors within the target demographic for enrollment in this experiment?
"This trial allows for the inclusion of adult patients aged 18 and above, with a cap at 95."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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