- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01754922
Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function (AirHzds)
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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New Jersey
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East Orange, New Jersey, Forente stater, 07018
- East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Exposed
Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
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Control
OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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FEV1
Tidsramme: Pre/post exercise; cross-sectional
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Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge
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Pre/post exercise; cross-sectional
|
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VO2 Peak
Tidsramme: At peak exercise; cross-sectional
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Maximal oxygen consumption measured during exercise
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At peak exercise; cross-sectional
|
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Heart Rate Variability
Tidsramme: Resting baseline; cross-sectional
|
Ratio of low-frequency to high-frequency power for heart rate variability
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Resting baseline; cross-sectional
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Michael Joseph Falvo, PhD, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- F1079-P
- 1I21RX001079-01A (Annet stipend/finansieringsnummer: VA ORD RR&D)
- 1I21RX001079-01 (U.S. NIH-stipend/kontrakt)
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