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Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease

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ClinicalTrials.gov Identifier: NCT00415272
Recruitment Status : Terminated (Inadequate enrollment.)
First Posted : December 22, 2006
Last Update Posted : January 15, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Fibrotic Interstitial Lung Disease Behavioral: Pulmonary Rehabilitation

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Completion Date : July 2007

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00415272     History of Changes
Other Study ID Numbers: H52476-29802-01
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008

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