Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01055730
First received: January 25, 2010
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Interstitial Lung Disease
Other: Pulmonary rehabilitation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Pulmonary Rehabilitation in Interstitial Lung Disease: A Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 6-minute walk distance [ Time Frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dyspnea [ Time Frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: February 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pulmonary rehabilitation Other: Pulmonary rehabilitation
Structured education and supervised exercise program, lasting between 6 and 9 weeks.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055730

Locations
United States, California
John Muir Health
Concord, California, United States, 94520
Seton Pulmonary & Cardiac Rehabilitation
Daly City, California, United States, 94015
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8057
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Harold R Collard, MD University of California, San Francisco
Principal Investigator: Christopher J Ryerson, MD University of California, San Francisco
Principal Investigator: Chris Garvey, FNP Seton Pulmonary & Cardiac Rehabilitation
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01055730     History of Changes
Other Study ID Numbers: PR-ILD
Study First Received: January 25, 2010
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Pulmonary rehabilitation
Exercise therapy
Interstitial lung disease
Pulmonary fibrosis
Mobility limitation
Dyspnea
Mental health

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014