Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function

NCT01754922 | Completed Results DMC

• 3 other identifiers: F1079-P1I21RX001079-01A1I21RX001079-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormality, Respiratory System; Autonomic Nervous System

Keywords

exercise tolerance; Veterans; operation enduring freedom; operation Iraqi freedom

Outcome Measures

Primary Outcomes (3)

• FEV1

  Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge

  Pre/post exercise; cross-sectional

• VO2 Peak

  Maximal oxygen consumption measured during exercise

  At peak exercise; cross-sectional

• Heart Rate Variability

  Ratio of low-frequency to high-frequency power for heart rate variability

  Resting baseline; cross-sectional

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample, outpatient clinic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

East Orange, New Jersey, 07018, United States

Location

Related Links

• PI contact information and study site information

Biospecimen

Retention: NONE RETAINED

No biospecimens will be collected

MeSH Terms

Conditions

Respiratory System Abnormalities

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Michael Falvo
• Organization: VA NJ Health Care System

Michael.Falvo@va.gov

973-676-1000

Study Officials

• Michael Joseph Falvo, PhD

  East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: November 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 28, 2017
• Results First Posted: October 26, 2016

Record last verified: 2017-01

Locations

US (1)