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Beneficial Effects of Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
This study has been completed.
Sponsor:
National Jewish Health
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health
ClinicalTrials.gov Identifier:
NCT01107028
First received: April 16, 2010
Last updated: March 27, 2017
Last verified: March 2017
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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:
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| 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
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: NCT01107028
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Publications:
| Responsible Party: | Jennifer Brandorff, Regulatory Manager, National Jewish Health |
| ClinicalTrials.gov Identifier: | NCT01107028 History of Changes |
| Other Study ID Numbers: |
NJ230 K23HL092227-01A2 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | April 16, 2010 |
| Last Updated: | March 27, 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 |
ClinicalTrials.gov processed this record on June 23, 2017