- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00692796
Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
March 27, 2017 updated by: National Jewish Health
The purpose of this study is to determine the effects of Pulmonary Rehabilitation (PR) on shortness of breath, exercise capacity, symptom control, mental health, cognitive function, and quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF).
Pulmonary rehabilitation has already been shown to benefit patients with other chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD).
We believe that pulmonary rehabilitation will benefit patients with IPF as well.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The goals of this project are to assess the effect of PR on a number of important outcomes in patients with IPF.
Once enrolled in the study, subjects will complete a battery of questionnaires and tests that assess symptoms, quality of life, cognition, and mental health, and then subjects will complete a six week outpatient PR program (at National Jewish Medical and Research Center or other PR programs).
Subjects will complete the same battery of questionnaires and tests immediately after completion of the PR program and again six months later.
Study Type
Interventional
Enrollment (Actual)
60
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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Colorado
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Denver, Colorado, United States, 80206
- National Jewish Medical and Research Center
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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
40 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 40 years or older
- Diagnosis of IPF according to American Thoracic Society criteria
Exclusion criteria:
- Patients who have completed a PR program within the last two years
- Patients with unstable medical conditions that would make PR unsafe
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: NA
- Interventional Model: SINGLE_GROUP
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
|
Pulmonary rehabilitation is a multi-disciplinary program that includes exercise training, disease education, psychosocial education (e.g., stress management, coping with chronic illness) and nutrition education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exercise capacity
Time Frame: 6 weeks and again at 6 months
|
6 weeks and again at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cognition
Time Frame: 6 weeks and again at 6 months
|
6 weeks and again at 6 months
|
Quality of life
Time Frame: 6 weeks and again at 6 months
|
6 weeks and again at 6 months
|
Fatigue
Time Frame: 6 weeks and again at 6 months
|
6 weeks and again at 6 months
|
Anxiety
Time Frame: 6 weeks and again at 6 months
|
6 weeks and again at 6 months
|
Depression
Time Frame: 6 weeks and again at 6 months
|
6 weeks and again at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeff Swigris, DO, MS, National Jewish Medical and Research Center (Jeffrey J. Swigris, DO, MS; Assistant Professor of Medicine)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Start
April 1, 2008
Primary Completion (ACTUAL)
March 1, 2010
Study Completion (ACTUAL)
March 1, 2010
Study Registration Dates
First Submitted
June 4, 2008
First Submitted That Met QC Criteria
June 4, 2008
First Posted (ESTIMATE)
June 6, 2008
Study Record Updates
Last Update Posted (ACTUAL)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NJMRC HS 1603 substudy
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 Idiopathic Pulmonary Fibrosis
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St. Antonius HospitalZonMw: The Netherlands Organisation for Health Research and Development; Boeringer...RecruitingPulmonary Fibrosis Idiopathic FamilialNetherlands
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Wake Forest University Health SciencesMayo Clinic; The University of Texas Health Science Center at San AntonioCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
Sheba Medical CenterUnknownIDIOPATHIC PULMONARY FIBROSISIsrael
-
Theravance BiopharmaTerminatedIdiopathic Pulmonary Fibrosis (IPF)United Kingdom
-
University of California, San FranciscoCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
BiogenCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
Liminal BioSciences Ltd.CompletedIdiopathic Pulmonary Fibrosis (IPF)Canada
-
Bristol-Myers SquibbCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
Angion Biomedica CorpNot yet recruitingIdiopathic Pulmonary Fibrosis (IPF)
-
Xfibra, Inc.Not yet recruitingIdiopathic Pulmonary Fibrosis (IPF)
Clinical Trials on Pulmonary rehabilitation
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Faculty of Medicine, SousseCompletedChronic Obstructive Pulmonary DiseaseTunisia
-
Universidade Federal de Santa MariaCompletedChronic Obstructive Pulmonary DiseaseBrazil
-
Istanbul Medipol University HospitalRecruitingLung Diseases | Bronchiectasis | Lung Diseases, Interstitial | Pulmonary RehabilitationTurkey
-
La Trobe UniversityMonash University; The Alfred; Austin HealthCompletedChronic Obstructive Pulmonary DiseaseAustralia
-
Aveiro UniversityCentro Hospitalar do Baixo VougaRecruitingChronic Obstructive Pulmonary Disease | Interstitial Lung DiseasePortugal
-
National Cheng-Kung University HospitalCompletedTelerehabilitation | Pulmonary Rehabilitation | Compliance, Patient | COPD | Cardiopulmonary Exercise TestTaiwan
-
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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Michaël RACODONRecruitingRespiratory DiseasesFrance