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Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function (AirHzds)

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. Identifier: NCT01754922
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : October 26, 2016
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Following deployment to Operations Enduring and Iraqi Freedom and Operation New Dawn (OEF/OIF/OND), Veterans report breathing problems, difficulty exercising and other symptoms. These symptoms may be related to deployment exposures, such as regional dust and sand, smoke from burning trash, and local industry. Studies have reported poor air quality, but very little is known about the effect that exposure to this polluted air may have on Veterans' short- and long-term health. Investigators will determine whether deployment-related exposures have affected respiratory and nervous system function in these Veterans - data that may then be used to guide rehabilitation. Ultimately, the investigators' long-term goal is to prevent the development of chronic respiratory conditions in this group of OEF/OIF/OND Veterans.

Condition or disease
Abnormality, Respiratory System Autonomic Nervous System

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Time Perspective: Cross-Sectional
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

Primary Outcome Measures :
  1. FEV1 [ Time Frame: Pre/post exercise; cross-sectional ]
    Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge

  2. VO2 Peak [ Time Frame: At peak exercise; cross-sectional ]
    Maximal oxygen consumption measured during exercise

  3. 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
No biospecimens will be collected

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample, outpatient clinic

Inclusion Criteria:

  • Male and female Veterans between 18 - 55 years of age will be identified and screened for this study.
  • Two study cohorts will be recruited and attempts will be made to match group composition on age, body mass index and smoking history.
  • Veterans assigned to the Exposed group must have been deployed to OEF/OIF for a minimum of 90 consecutive days.
  • The Control group will consist of Veterans never deployed to Southwest Asia (i.e. OEF/OIF, Persian Gulf War) but were deployed during the same time period.
  • Each Veteran will complete a detailed exposure history questionnaire to confirm and support their group assignment.

Exclusion Criteria:

Participants must not meet any of the contraindications to exercise testing as described in the joint statement from the American College of Cardiology and American Heart Association. Also, individuals with history of any of the following will also be excluded:

  • asthma (pre-military)
  • cardiovascular disease
  • neurological impairment/disorder
  • pregnant
  • uncontrollable hypertension (SBP > 160; DBP > 100)
  • or have suffered severe/moderate traumatic brain injury within the last three years
  • eye/chest/abdominal surgery in last 3 months
  • tuberculosis exposure to self or household member
  • history of aneurysm or collapsed lung
  • history of detached retina
  • stroke or heart attack in the last 3 months
  • and history of coughing up blood in last three months

(With the exception of hypertension and pregnancy (urine test), all exclusion criteria will be determined via self-report)

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 identifier (NCT number): NCT01754922

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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
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Michael Joseph Falvo, PhD East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
Additional Information:
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Responsible Party: VA Office of Research and Development Identifier: NCT01754922    
Other Study ID Numbers: F1079-P
1I21RX001079-01A ( Other Grant/Funding Number: VA ORD RR&D )
1I21RX001079-01 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2012    Key Record Dates
Results First Posted: October 26, 2016
Last Update Posted: February 28, 2017
Last Verified: January 2017
Keywords provided by VA Office of Research and Development:
exercise tolerance
operation enduring freedom
operation Iraqi freedom
Additional relevant MeSH terms:
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Respiratory System Abnormalities
Congenital Abnormalities
Respiratory Tract Diseases