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Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease

Primary Purpose

Fibrotic Interstitial Lung Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrotic Interstitial Lung Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

  • University of California at San Francisco

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 20, 2006
Last Updated
January 11, 2008
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00415272
Brief Title
Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Terminated
Why Stopped
Inadequate enrollment.
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrotic Interstitial Lung Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Pulmonary Rehabilitation

10. Eligibility

Sex
All
Eligibility Criteria
Inclusion Criteria: Restriction on pulmonary function testing (TLC <80%, FEV1/FVC ratio > predicted or DLCO < 80%) Evidence of fibrosis on high resolution computed tomography of the chest. Fibrosis on surgical lung biopsy if performed Referral for pulmonary rehabilitation Exclusion Criteria: Participation in pulmonary rehabilitation in the past 24 months Inability to complete 6 minute walk test or study questionnaires Limitations other than dyspnea (e.g. arthritis) that affect ability to participate in pulmonary rehabilitation Baseline 6 minute walk distance > 400 meters Planned change in medication treatment for lung disease during the course of pulmonary rehabilitation Ejection fraction known to be < 25% 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) FEV1/FVC < 65% Unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold R Collard, MD
Organizational Affiliation
University of California at San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94123
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease

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