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Beneficial Effects of Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT01107028
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health

Study Description
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Brief Summary:
Idiopathic pulmonary fibrosis (IPF) is a devastating disease marked by progressive lung scarring leading to multiple life-altering sequelae. The over-arching goals of the principal investigator's research program are to more fully characterize these sequelae and to examine interventions that might improve them. The hypotheses of this particular study are that pulmonary rehabilitation (PR) is one such intervention, and that PR will improve the sequelae of dyspnea and impairments in functional capacity, cognition, mood and anxiety, fatigue, and quality of life (QOL) in patients with IPF.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Other: Standard pulmonary rehabilitation program

Detailed Description:

Subjects will come to our center to be enrolled. Baseline data collection (performance of a six-minute walk test and completion of questionnaires) and randomization to one of two groups--either Rehab or Wait--will take place at the same enrollment visit if time permits. Subjects in either group will complete pulmonary rehabilitation, just at slightly different times, depending on which group they are randomized to.

Pulmonary rehabilitation is a program run by respiratory and/or physical therapists and other health professionals that involves exercise, education, and support with the goals to improve functional capacity, symptom management, and well-being. It will last 6-8 weeks, during which time, subjects will complete 18 approximately hour-long sessions. Pulmonary rehabilitation may be completed at any local center that makes travel convenient.

Data collection visits will take place at National Jewish Health at baseline, eight weeks (without intervening pulmonary rehabilitation in the Wait group), after completion of pulmonary rehabilitation (time varies, depending on the randomization group), and finally six months after completion of the pulmonary rehabilitation program.


Study Design
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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
Study Start Date : February 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Rehab
Subjects randomized to the Rehab group will have data collected at baseline and then within one week enroll in a pulmonary rehabilitation program. Data will again be collected within one week of completing pulmonary rehabilitation and again six months later.
 Other: Standard pulmonary rehabilitation program
At the assigned time, subjects will complete a six-week, outpatient pulmonary rehabilitation program at any local center that has such a program.
Wait
Subjects randomized to the Wait group will have data collected at baseline and wait eight weeks before enrolling in a pulmonary rehabilitation program. Data will again be collected within one week of completing pulmonary rehabilitation and again six months later.
 Other: Standard pulmonary rehabilitation program
At the assigned time, subjects will complete a six-week, outpatient pulmonary rehabilitation program at any local center that has such a program.


Outcome Measures
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Primary Outcome Measures :
  1. Six-minute walk distance [ Time Frame: Eight weeks ]
    Distance walked during a standard six-minute walk test.


Secondary Outcome Measures :
  1. dyspnea, fatigue, anxiety, depression, quality of life [ Time Frame: Eight weeks ]
  2. Six minute walk distance [ Time Frame: Six months after completion of pulmonary rehabilitation ]
  3. dyspnea, fatigue, anxiety, depression, quality of life [ Time Frame: Six months after completion of pulmonary rehabilitation ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Idiopathic pulmonary fibrosis, as defined by the American Thoracic Society Consensus Guidelines
Criteria

Inclusion Criteria:

  • Age > 40 years
  • IPF
  • Able to walk unassisted for balance
  • Able to speak and understand English well enough to complete complex tasks with directions given in English

Exclusion Criteria:

  • Pulmonary fibrosis not due to IPF
  • Coexisting comorbid conditions that would make exercise contraindicated
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107028


Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jeffrey J. Swigris, DO, MS National Jewish Health
More Information
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Additional Information:
National Jewish website information for this study  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health
ClinicalTrials.gov Identifier: NCT01107028     History of Changes
Other Study ID Numbers: NJ230
K23HL092227-01A2 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Jennifer Brandorff, National Jewish Health:
Idiopathic pulmonary fibrosis
Dyspnea
Functional capacity
Quality of life

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