Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease

This study has been terminated.

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00415272

Purpose

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.

Condition	Intervention
Fibrotic Interstitial Lung Disease	Behavioral: Pulmonary Rehabilitation

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Further study details as provided by University of California, San Francisco:

Study Completion Date:

July 2007

Eligibility

Genders Eligible for Study:

Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415272

Locations

United States, California
University of California at San Francisco
San Francisco, California, United States, 94123

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Harold R Collard, MD

University of California at San Francisco

More Information

Study ID Numbers:	H52476-29802-01
Study First Received:	December 20, 2006
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00415272
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Lung Diseases, Interstitial
Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on January 16, 2009