The Impact of Pulmonary Rehabilitation in Interstitial Lung Disease (PR-ILD)

November 19, 2013 updated by: University of California, San Francisco

The Impact of Pulmonary Rehabilitation in Interstitial Lung Disease: A Prospective Cohort Study

The purpose of this study is to determine if pulmonary rehabilitation has any effect on breathlessness, quality of life, physical function and depression in persons with interstitial lung disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • University of British Columbia
  • United States
    • California
      • Concord, California, United States, 94520
        • John Muir Health
      • Daly City, California, United States, 94015
        • Seton Pulmonary & Cardiac Rehabilitation
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8057
        • Yale University School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient with interstitial lung disease who is referred to a participating pulmonary rehabilitation program. These patients typically have exercise limitation and dyspnea, but still possess the ability to perform some exercise.

Description

Inclusion Criteria:

  • Adults (> 18 years old) with a diagnosis of ILD who are referred to a participating PR program

Exclusion Criteria:

  • Inability to provide informed consent
  • Inability to read and write English
  • Any other medical condition that significantly limits the subject's ability to perform the functional measures
  • Emphysema / Chronic bronchitis (FEV1 / FVC ratio < 60%)
  • Previous pulmonary rehabilitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pulmonary rehabilitation
Other: Pulmonary rehabilitation
Structured education and supervised exercise program, lasting between 6 and 9 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6-minute walk distance
Time Frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Quality of life
Time Frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation

Secondary Outcome Measures

Outcome Measure
Time Frame
Dyspnea
Time Frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Depression
Time Frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation
Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Christopher J Ryerson, MD, University of California, San Francisco
  • Principal Investigator: Chris Garvey, FNP, Seton Pulmonary & Cardiac Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-ILD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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