Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients
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ClinicalTrials.gov Identifier: NCT01118221 |
Recruitment Status
:
Completed
First Posted
: May 6, 2010
Results First Posted
: January 16, 2015
Last Update Posted
: March 4, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | April 27, 2010 | |||
First Posted Date ICMJE | May 6, 2010 | |||
Results First Submitted Date | November 19, 2014 | |||
Results First Posted Date | January 16, 2015 | |||
Last Update Posted Date | March 4, 2015 | |||
Study Start Date ICMJE | October 2010 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
6 Minute Walk Distance [ Time Frame: The 6-MWD will be measured at 0 and 3 months. ] Change in 6 Minute Walk Distance from Baseline to 3 Months
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Original Primary Outcome Measures ICMJE |
6 Minute Walk Distance [ Time Frame: The 6-MWD will be measured at 0, 3 and 6 months. ] | |||
Change History | Complete list of historical versions of study NCT01118221 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients | |||
Official Title ICMJE | Rehabilitation of IPF Patients: Effects of Exercise and Oxidant Stress | |||
Brief Summary | The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more often in older males. Cigarette smoking and environmental dust exposures are known risk factors for developing IPF. For example, the recently deployed military population, as it ages, is at especially increased risk of IPF. No effective therapies exist, although lung transplantation is used to extend survival of selected patients. Defining specific therapy to improve exercise tolerance and dyspnea in IPF patients is thus an urgent priority of veteran-oriented research programs. |
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Detailed Description | Chronic lung disease is common in the veteran population. While chronic obstructive pulmonary disease (COPD) is most prominent, fibrotic lung diseases, typified by idiopathic pulmonary fibrosis (IPF), are clearly increasing. We have developed extensive experience with a VA idiopathic pulmonary fibrosis (IPF) population in the context of a randomized, controlled clinical trial of vasodilator therapy. Based on the current literature and our preliminary experience with exercise testing in IPF patients, we hypothesize that:
Our Specific Objectives are:
To test the working hypothesis that improved outcomes are associated with more efficient O2 utilization, decreased markers of oxidant stress and maintained effort dependent pulmonary function, the following variables will be measured:
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Idiopathic Pulmonary Fibrosis | |||
Intervention ICMJE | Behavioral: pulmonary rehabilitation
structured exercise program |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
25 | |||
Original Estimated Enrollment ICMJE |
50 | |||
Actual Study Completion Date | September 2013 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 40 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01118221 | |||
Other Study ID Numbers ICMJE | O7467-R | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | VA Office of Research and Development | |||
Study Sponsor ICMJE | VA Office of Research and Development | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | VA Office of Research and Development | |||
Verification Date | February 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |