Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease

Fibrotic Interstitial Lung Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00415272
• Other study ID #: H52476-29802-01
• Status: Terminated
• Phase: N/A
• First received: December 20, 2006
• Last updated: January 11, 2008
• Est. completion date: July 2007

Study information

• Verified date: January 2008
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: July 2007
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fibrotic Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Behavioral:
• Pulmonary Rehabilitation

Locations

Country	Name	City	State
United States	University of California at San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States,