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Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease

This study has been terminated.
(Inadequate enrollment.)
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00415272
First received: December 20, 2006
Last updated: January 11, 2008
Last verified: January 2008
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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:

  1. Restriction on pulmonary function testing (TLC <80%, FEV1/FVC ratio > predicted or DLCO < 80%)
  2. Evidence of fibrosis on high resolution computed tomography of the chest.
  3. Fibrosis on surgical lung biopsy if performed
  4. Referral for pulmonary rehabilitation

Exclusion Criteria:

  1. Participation in pulmonary rehabilitation in the past 24 months
  2. Inability to complete 6 minute walk test or study questionnaires
  3. Limitations other than dyspnea (e.g. arthritis) that affect ability to participate in pulmonary rehabilitation
  4. Baseline 6 minute walk distance > 400 meters
  5. Planned change in medication treatment for lung disease during the course of pulmonary rehabilitation
  6. Ejection fraction known to be < 25%
  7. 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)
  8. FEV1/FVC < 65%
  9. 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

No publications provided

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

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013