Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function (AirHzds)

10 januari 2017 uppdaterad av: VA Office of Research and Development
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.

Studieöversikt

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

Observationell

Inskrivning (Faktisk)

50

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • New Jersey
      • East Orange, New Jersey, Förenta staterna, 07018
        • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 55 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Community sample, outpatient clinic

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
FEV1
Tidsram: Pre/post exercise; cross-sectional
Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge
Pre/post exercise; cross-sectional
VO2 Peak
Tidsram: At peak exercise; cross-sectional
Maximal oxygen consumption measured during exercise
At peak exercise; cross-sectional
Heart Rate Variability
Tidsram: Resting baseline; cross-sectional
Ratio of low-frequency to high-frequency power for heart rate variability
Resting baseline; cross-sectional

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Michael Joseph Falvo, PhD, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2013

Primärt slutförande (Faktisk)

1 augusti 2015

Avslutad studie (Faktisk)

1 december 2015

Studieregistreringsdatum

Först inskickad

18 december 2012

Först inskickad som uppfyllde QC-kriterierna

18 december 2012

Första postat (Uppskatta)

21 december 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 februari 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 januari 2017

Senast verifierad

1 januari 2017

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • F1079-P
  • 1I21RX001079-01A (Annat bidrag/finansieringsnummer: VA ORD RR&D)
  • 1I21RX001079-01 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Autonoma nervsystemet

3
Prenumerera