Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415272
Recruitment Status : Terminated (Inadequate enrollment.)
First Posted : December 22, 2006
Last Update Posted : January 15, 2008
Information provided by:
University of California, San Francisco

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 Phase
Fibrotic Interstitial Lung Disease Behavioral: Pulmonary Rehabilitation Not Applicable

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

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00415272

United States, California
University of California at San Francisco
San Francisco, California, United States, 94123
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Harold R Collard, MD University of California at San Francisco 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