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Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Mordecai Palliative Care Research Fund
Information provided by:
National Jewish Health
ClinicalTrials.gov Identifier:
NCT00692796
First received: June 4, 2008
Last updated: April 16, 2010
Last verified: July 2008
History of Changes
  Purpose

The purpose of this study is to determine the effects of Pulmonary Rehabilitation (PR) on shortness of breath, exercise capacity, symptom control, mental health, cognitive function, and quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). Pulmonary rehabilitation has already been shown to benefit patients with other chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD). We believe that pulmonary rehabilitation will benefit patients with IPF as well.


Condition Intervention
Idiopathic Pulmonary Fibrosis
 Other: Pulmonary rehabilitation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • Exercise capacity [ Time Frame: 6 weeks and again at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognition [ Time Frame: 6 weeks and again at 6 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 weeks and again at 6 months ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: 6 weeks and again at 6 months ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: 6 weeks and again at 6 months ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 6 weeks and again at 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: Pulmonary rehabilitation
Pulmonary rehabilitation is a multi-disciplinary program that includes exercise training, disease education, psychosocial education (e.g., stress management, coping with chronic illness) and nutrition education.

Detailed Description:

The goals of this project are to assess the effect of PR on a number of important outcomes in patients with IPF. Once enrolled in the study, subjects will complete a battery of questionnaires and tests that assess symptoms, quality of life, cognition, and mental health, and then subjects will complete a six week outpatient PR program (at National Jewish Medical and Research Center or other PR programs). Subjects will complete the same battery of questionnaires and tests immediately after completion of the PR program and again six months later.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40 years or older
  • Diagnosis of IPF according to American Thoracic Society criteria

Exclusion criteria:

  • Patients who have completed a PR program within the last two years
  • Patients with unstable medical conditions that would make PR unsafe
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692796

Locations
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Mordecai Palliative Care Research Fund
Investigators
Principal Investigator: Jeff Swigris, DO, MS National Jewish Medical and Research Center (Jeffrey J. Swigris, DO, MS; Assistant Professor of Medicine)
  More Information

No publications provided by National Jewish Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeff Swigris, DO, MS, National Jewish Medical and Research Center
ClinicalTrials.gov Identifier: NCT00692796     History of Changes
Other Study ID Numbers: NJMRC HS 1603 substudy
Study First Received: June 4, 2008
Last Updated: April 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by National Jewish Health:
Pulmonary fibrosis
Pulmonary rehabilitation
Dyspnea
Quality of life

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on May 19, 2013