Back to resultsPulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Pulmonary fibrosis, Pulmonary rehabilitation, Dyspnea, Quality of life
Eligibility 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
Sites / Locations
- National Jewish Medical and Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Exercise capacity
Secondary Outcome Measures
Cognition
Quality of life
Fatigue
Anxiety
Depression
Full Information
NCT ID
NCT00692796
First Posted
June 4, 2008
Last Updated
March 27, 2017
Sponsor
National Jewish Health
Collaborators
Mordecai Palliative Care Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT00692796
Brief Title
Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
Official Title
Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Jewish Health
Collaborators
Mordecai Palliative Care Research Fund
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Pulmonary fibrosis, Pulmonary rehabilitation, Dyspnea, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise capacity
Time Frame
6 weeks and again at 6 months
Secondary Outcome Measure Information:
Title
Cognition
Time Frame
6 weeks and again at 6 months
Title
Quality of life
Time Frame
6 weeks and again at 6 months
Title
Fatigue
Time Frame
6 weeks and again at 6 months
Title
Anxiety
Time Frame
6 weeks and again at 6 months
Title
Depression
Time Frame
6 weeks and again at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Swigris, DO, MS
Organizational Affiliation
National Jewish Medical and Research Center (Jeffrey J. Swigris, DO, MS; Assistant Professor of Medicine)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21333082
Citation
Swigris JJ, Fairclough DL, Morrison M, Make B, Kozora E, Brown KK, Wamboldt FS. Benefits of pulmonary rehabilitation in idiopathic pulmonary fibrosis. Respir Care. 2011 Jun;56(6):783-9. doi: 10.4187/respcare.00939. Epub 2011 Feb 11. Erratum In: Respir Care. 2013 Apr;58(4):e51.
Results Reference
derived
Learn more about this trial
Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
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