- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00415272
Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease
January 11, 2008 updated by: University of California, San Francisco
Our study aims to investigate the benefits of an outpatient pulmonary rehabilitation program in a population of subjects with fibrotic interstitial lung disease.
Our hypothesis is that pulmonary rehabilitation will lead to improvements in quality of life, breathlessness, exercise capacity and pulmonary function in this patient population.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94123
- University of California at San Francisco
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Restriction on pulmonary function testing (TLC <80%, FEV1/FVC ratio > predicted or DLCO < 80%)
- Evidence of fibrosis on high resolution computed tomography of the chest.
- Fibrosis on surgical lung biopsy if performed
- Referral for pulmonary rehabilitation
Exclusion Criteria:
- Participation in pulmonary rehabilitation in the past 24 months
- Inability to complete 6 minute walk test or study questionnaires
- Limitations other than dyspnea (e.g. arthritis) that affect ability to participate in pulmonary rehabilitation
- Baseline 6 minute walk distance > 400 meters
- Planned change in medication treatment for lung disease during the course of pulmonary rehabilitation
- Ejection fraction known to be < 25%
- Contraindications to pulmonary rehabilitation (clinically unstable, uncontrolled arrhythmia or hypertension, symptomatic or uncontrolled hypotension with systolic blood pressure of < 95, active angina, unexplained syncope or worsening dizziness, limiting orthopedic or neurological disorders, psychiatric impairment that inhibits cooperation in the program)
- FEV1/FVC < 65%
- Unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Harold R Collard, MD, University of California at San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
December 20, 2006
First Submitted That Met QC Criteria
December 21, 2006
First Posted (Estimate)
December 22, 2006
Study Record Updates
Last Update Posted (Estimate)
January 15, 2008
Last Update Submitted That Met QC Criteria
January 11, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H52476-29802-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fibrotic Interstitial Lung Disease
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University of AlbertaAlberta Boehringer Ingelheim CollaborationNot yet recruitingFibrotic Interstitial Lung Disease
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Monash UniversityRecruitingFibrotic Interstitial Lung DiseaseAustralia
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Assistance Publique - Hôpitaux de ParisNot yet recruitingFibrotic Interstitial Lungs DiseasesFrance
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Mayo ClinicBoehringer IngelheimRecruitingFibrotic Interstitial Lung DiseaseUnited States
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Monash UniversityRecruitingFibrotic Interstitial Lung DiseaseAustralia
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Berner Reha Zentrum AGUniversity of Zurich; Zurich University of Applied Sciences; Insel Gruppe AG,...RecruitingQuality of Life | Interstitial Lung Disease | Self Efficacy | Self-management | Patient Education | Fibrotic Lung DiseaseSwitzerland
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Kingston UniversityUniversity College London Hospitals; St. George's Hospital, LondonCompletedIdiopathic Pulmonary Fibrosis | Interstitial Lung Disease | Chronic Hypersensitivity Pneumonitis | Connective Tissue Related ILD | Fibrotic Lung DiseaseUnited Kingdom
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King's College Hospital NHS TrustNot yet recruitingBronchiectasis | Chronic Obstructive Pulmonary Disease | Asthma | Lung Cancer | Interstitial Lung Disease | Chronic Lung Disease | Dyspnea | Fibrotic Lung DiseaseUnited Kingdom
-
Matthias GrieseSuspendedInterstitial Lung Disease | Diffuse Parenchymal Lung Disease | Children´s Interstitial Lung DiseaseGermany
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Boehringer IngelheimNo longer availableLung Diseases, Interstitial (in Pediatric Populations) | Childhood Interstitial Lung Disease (chILD)
Clinical Trials on Pulmonary Rehabilitation
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Faculty of Medicine, SousseCompletedChronic Obstructive Pulmonary DiseaseTunisia
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Universidade Federal de Santa MariaCompletedChronic Obstructive Pulmonary DiseaseBrazil
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Istanbul Medipol University HospitalRecruitingLung Diseases | Bronchiectasis | Lung Diseases, Interstitial | Pulmonary RehabilitationTurkey
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La Trobe UniversityMonash University; The Alfred; Austin HealthCompletedChronic Obstructive Pulmonary DiseaseAustralia
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Aveiro UniversityCentro Hospitalar do Baixo VougaRecruitingChronic Obstructive Pulmonary Disease | Interstitial Lung DiseasePortugal
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National Cheng-Kung University HospitalCompletedTelerehabilitation | Pulmonary Rehabilitation | Compliance, Patient | COPD | Cardiopulmonary Exercise TestTaiwan
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Istanbul Medipol University HospitalCompletedEmphysema | Bronchoscopic Lung Volume Reduction | Hospital-based Pulmonary Rehabilitation | Home-based Pulmonary RehabilitationTurkey
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Hospital Clinic of BarcelonaSociedad Española de Neumología y Cirugía TorácicaUnknownNon-cystic Fibrosis Bronchiectasis
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University of MaltaCompletedInterstitial Lung DiseaseMalta
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University of MaltaNot yet recruitingChronic Obstructive Pulmonary Disease