Beneficial Effects of Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01107028

First Posted: April 20, 2010

Last Update Posted: March 29, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

Jennifer Brandorff, National Jewish Health

Purpose

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	Intervention
Idiopathic Pulmonary Fibrosis	Other: Standard pulmonary rehabilitation program


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: idiopathic pulmonary fibrosis

MedlinePlus related topics: Pulmonary Fibrosis Rehabilitation

Genetic and Rare Diseases Information Center resources: Idiopathic Pulmonary Fibrosis

U.S. FDA Resources

Further study details as provided by Jennifer Brandorff, National Jewish Health:

Primary Outcome Measures:

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

Secondary Outcome Measures:

dyspnea, fatigue, anxiety, depression, quality of life [ Time Frame: Eight weeks ]
Six minute walk distance [ Time Frame: Six months after completion of pulmonary rehabilitation ]
dyspnea, fatigue, anxiety, depression, quality of life [ Time Frame: Six months after completion of pulmonary rehabilitation ]


Enrollment:	41
Study Start Date:	February 2010
Study Completion Date:	October 2014
Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

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.

Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	40 Years and older (Adult, Senior)
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

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

Additional Information:

National Jewish website information for this study This link exits the ClinicalTrials.gov site

Publications:

Swigris JJ, Brown KK, Make BJ, Wamboldt FS. Pulmonary rehabilitation in idiopathic pulmonary fibrosis: a call for continued investigation. Respir Med. 2008 Dec;102(12):1675-80. doi: 10.1016/j.rmed.2008.08.014. Epub 2008 Oct 10. Review.


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 Submitted:	April 16, 2010
First Posted:	April 20, 2010
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

To Top