- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01754922
Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function (AirHzds)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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New Jersey
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East Orange, New Jersey, Förenta staterna, 07018
- East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
FEV1
Tidsram: 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
Tidsram: 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
Tidsram: Resting baseline; cross-sectional
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Ratio of low-frequency to high-frequency power for heart rate variability
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Resting baseline; cross-sectional
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Michael Joseph Falvo, PhD, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- F1079-P
- 1I21RX001079-01A (Annat bidrag/finansieringsnummer: VA ORD RR&D)
- 1I21RX001079-01 (U.S.S. NIH-anslag/kontrakt)
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