Beneficial Effects of Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
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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 |
- Six-minute walk distance [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]Distance walked during a standard six-minute walk test.
- dyspnea, fatigue, anxiety, depression, quality of life [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
- Six minute walk distance [ Time Frame: Six months after completion of pulmonary rehabilitation ] [ Designated as safety issue: No ]
- dyspnea, fatigue, anxiety, depression, quality of life [ Time Frame: Six months after completion of pulmonary rehabilitation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | February 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Idiopathic pulmonary fibrosis, as defined by the American Thoracic Society Consensus Guidelines
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01107028
| United States, Colorado | |
| National Jewish Health | |
| Denver, Colorado, United States, 80206 | |
| Principal Investigator: | Jeffrey J. Swigris, DO, MS | National Jewish Health |
More Information
Additional Information:
Publications:
| Responsible Party: | Jeff Swigris, DO, MS, Assistant Professor of Medicine, National Jewish Health, Denver, CO |
| ClinicalTrials.gov Identifier: | NCT01107028 History of Changes |
| Other Study ID Numbers: | NJ230, K23HL092227-01A2 |
| Study First Received: | April 16, 2010 |
| Last Updated: | November 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by National Jewish Health:
|
Idiopathic pulmonary fibrosis Dyspnea Functional capacity Quality of life |
Additional relevant MeSH terms:
|
Fibrosis Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Idiopathic Interstitial Pneumonias |
Lung Diseases Lung Diseases, Interstitial Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on March 03, 2015