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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01754922
First received: December 18, 2012
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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
Abnormality, Respiratory System
Autonomic Nervous System

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Spirometry, heart rate variability [ Time Frame: Once - cross-sectional ] [ Designated as safety issue: No ]
    Physiological variables obtained pre and post exercise


Biospecimen Retention:   None Retained

No biospecimens will be collected


Estimated Enrollment: 56
Study Start Date: November 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Exposed
Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
Control
OEF/OIF/OND Veterans deployed to regions other than Southwest Asia

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample, outpatient clinic

Criteria

Inclusion Criteria:

  • Male and female Veterans between 18 - 55 years of age will be identified and screened for our 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.
  • Our 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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754922

Contacts
Contact: Michael J Falvo, PhD (973) 676-1000 ext 2423 Michael.Falvo@va.gov
Contact: Drew A Helmer, MD MS (800) 248-8005 drew.helmer@va.gov

Locations
United States, New Jersey
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ Recruiting
East Orange, New Jersey, United States, 07018
Contact: Sean L Johnson, BA    (973) 676-1000 ext 1824    Sean.Johnson2@va.gov   
Principal Investigator: Michael Joseph Falvo, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Joseph Falvo, PhD East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01754922     History of Changes
Other Study ID Numbers: F1079-P, 1I21RX001079-01A
Study First Received: December 18, 2012
Last Updated: October 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
exercise tolerance
veterans
operation enduring freedom
operation Iraqi freedom

Additional relevant MeSH terms:
Respiratory System Abnormalities
Congenital Abnormalities
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014