Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00415272
• Collaborator: (none)
• Location: 1

Study Details

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	Phase
Fibrotic Interstitial Lung Disease	Behavioral: Pulmonary Rehabilitation	N/A

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00415272
• Other Study ID Numbers: H52476-29802-01
• First Posted: Dec 22, 2006
• Last Update Posted: Jan 15, 2008
• Last Verified: Jan 1, 2008

• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Interstitial

Study Results

No Results Posted as of Jan 15, 2008