Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease

NCT ID: NCT00415272

Last Updated: 2008-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fibrotic Interstitial Lung Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pulmonary Rehabilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Principal Investigators

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Harold R Collard, MD

Role: PRINCIPAL_INVESTIGATOR

University of California at San Francisco

Locations

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University of California at San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H52476-29802-01

Identifier Type: -

Identifier Source: org_study_id

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