Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function (AirHzds)
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|ClinicalTrials.gov Identifier: NCT01754922|
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : October 26, 2016
Last Update Posted : February 28, 2017
|Condition or disease|
|Abnormality, Respiratory System Autonomic Nervous System|
Evidence is clear that Veterans deployed to Operations Enduring and Iraqi Freedom and Operation New Dawn (OEF/OIF/OND) have been exposed to high levels of particulate matter (PM) that exceeded environmental, occupational and military exposure guidelines. PM exposure is acknowledged as a risk factor for cardiovascular morbidity and mortality, and can increase the risk of and exacerbate airway disease. The reviewed epidemiology indicates a high prevalence of newly reported respiratory symptoms in OEF/OIF/OND Veterans that has significantly affected their deployment duties, including their physical exertion capability. Despite these retrospective data and limited air sampling reports, prospective studies are lacking. This pilot study will evaluate cardiorespiratory and autonomic function in OEF/OIF/OND Veterans as compared to Veterans never deployed to the region.
To evaluate cardiopulmonary function, each Veteran will undergo a standardized exercise challenge and bronchodilator spirometry. To evaluate autonomic nervous system function, investigators will examine indices of heart rate variability and cardiovascular reflex regulation (e.g. baroreflex sensitivity and cerebral autoregulation) during a variety of tasks.
Data derived from this pilot project will yield important insight on the extent and severity of cardiorespiratory and/or autonomic impairments - data that may provide intervention points for attenuating long-term adverse outcomes such as pulmonary and cardiovascular disease. Through early identification, treatment options (e.g. exercise therapy, pharmaceutical) may be implemented to enhance physiological function, with the goal of helping to alleviate symptoms and reduce chronic disease risk.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||December 2015|
Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
- FEV1 [ Time Frame: Pre/post exercise; cross-sectional ]Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge
- VO2 Peak [ Time Frame: At peak exercise; cross-sectional ]Maximal oxygen consumption measured during exercise
- Heart Rate Variability [ Time Frame: Resting baseline; cross-sectional ]Ratio of low-frequency to high-frequency power for heart rate variability
Biospecimen Retention: None Retained
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): NCT01754922
|United States, New Jersey|
|East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ|
|East Orange, New Jersey, United States, 07018|
|Principal Investigator:||Michael Joseph Falvo, PhD||East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ|