Clinical trial NCT01754922: Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function
Official title: Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abnormality, Respiratory System
Autonomic Nervous System
Keywords: exercise tolerance
Veterans
operation enduring freedom
operation Iraqi freedom
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-12-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample, outpatient clinic

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: FEV1
timeFrame: Pre/post exercise; cross-sectional
measure: VO2 Peak
timeFrame: At peak exercise; cross-sectional
measure: Heart Rate Variability
timeFrame: Resting baseline; cross-sectional
Secondary outcomes:
Other outcomes:
Locations:
city: East Orange
country: United States
facility: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
state: New Jersey
Study officials:
affiliation: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
name: Michael Joseph Falvo, PhD
role: PRINCIPAL_INVESTIGATOR
References: