Abnormality, Respiratory SystemAirHzdsNCT01754922
Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function
An observational study of Abnormality, Respiratory System and Autonomic Nervous System, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Abnormality, Respiratory System, Autonomic Nervous System
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample, outpatient clinic
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, 07018
About this study
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.
Read the 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.
- Keywords
- exercise tolerance, Veterans, operation enduring freedom, operation Iraqi freedom
- Medical subject headings
- Respiratory System Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge
Measured: Pre/post exercise; cross-sectional
VO2 Peak
Maximal oxygen consumption measured during exercise
Measured: At peak exercise; cross-sectional
Heart Rate Variability
Ratio of low-frequency to high-frequency power for heart rate variability
Measured: Resting baseline; cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startNov 2013
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abnormality, Respiratory SystemStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael Joseph Falvo, PhD, Principal investigator, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754922
- Sponsor's protocol ID
- F1079-P
- Other IDs
- 1I21RX001079-01A, 1I21RX001079-01
- Acronym
- AirHzds
- Status last verified
- Jan 2017
- First submitted
- 18 Dec 2012
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function
- ClinicalTrials.gov ID
- NCT01754922
- Acronym / sponsor ID
- AirHzds / F1079-P
- Keywords
- exercise tolerance, Veterans, operation enduring freedom, operation Iraqi freedom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Nov 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 26 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample, outpatient clinic
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FEV1
Time frame: Pre/post exercise; cross-sectional
Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge
VO2 Peak
Time frame: At peak exercise; cross-sectional
Maximal oxygen consumption measured during exercise
Heart Rate Variability
Time frame: Resting baseline; cross-sectional
Ratio of low-frequency to high-frequency power for heart rate variability
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- PI contact information and study site informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Joseph Falvo, PhD principal investigator
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormality, Respiratory System and Autonomic Nervous System, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 (time frame: Pre/post exercise; cross-sectional). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.