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| ID | Type | Description | Link |
|---|---|---|---|
| 1I21RX001079-01A | Other Grant/Funding Number | VA ORD RR&D | |
| 1I21RX001079-01 | U.S. NIH Grant/Contract | View source |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
(With the exception of hypertension and pregnancy (urine test), all exclusion criteria will be determined via self-report)
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Community sample, outpatient clinic
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| Name | Affiliation | Role |
|---|---|---|
| Michael Joseph Falvo, PhD | East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ | East Orange | New Jersey | 07018 | United States |
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| Label | URL |
|---|---|
| PI contact information and study site information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exposed | Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter |
| FG001 | Control | OEF/OIF/OND Veterans deployed to regions other than Southwest Asia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exposed | Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter |
| BG001 | Control | Veterans deployed to regions other than Iraq or Afghanistan or non-deployed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FEV1 | Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge | Posted | Mean | Standard Deviation | percentage of predicted normal values | Pre/post exercise; cross-sectional |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exposed | Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric emergency | Psychiatric disorders | Participant experienced a psychiatric emergency upon arrival for a laboratory visits. A staff psychologist evaluated the participant and admitted to the emergency room for further clinical care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Falvo | VA NJ Health Care System | 973-676-1000 | 2423 | Michael.Falvo@va.gov |
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| ID | Term |
|---|---|
| D015619 | Respiratory System Abnormalities |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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No biospecimens will be collected
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Tobacco Pack Years | Mean | Standard Deviation | Pack Years |
|
| Counts |
|---|
| Participants |
|
|
| Primary | VO2 Peak | Maximal oxygen consumption measured during exercise | 4 participants were excluded due to failure to meet maximal exercise criteria (3 from exposed, 1 from control). Therefore, we removed these individuals from the final analysis. | Posted | Mean | Standard Deviation | ml/min/kg | At peak exercise; cross-sectional |
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|
|
| Primary | Heart Rate Variability | Ratio of low-frequency to high-frequency power for heart rate variability | Signal quality of the the electrocardiogram was poor for 3 individuals; therefore, their data were removed from final analysis. | Posted | Mean | Standard Deviation | Ratio | Resting baseline; cross-sectional |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Control | OEF/OIF/OND Veterans deployed to regions other than Southwest Asia or non-deployed | 1 | 18 | 0 | 18 |
|
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