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

10. januar 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New Jersey
      • East Orange, New Jersey, Forenede Stater, 07018
        • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Community sample, outpatient clinic

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
FEV1
Tidsramme: 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
Tidsramme: At peak exercise; cross-sectional
Maximal oxygen consumption measured during exercise
At peak exercise; cross-sectional
Heart Rate Variability
Tidsramme: Resting baseline; cross-sectional
Ratio of low-frequency to high-frequency power for heart rate variability
Resting baseline; cross-sectional

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

VA Office of Research and Development

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2013

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

18. december 2012

Først indsendt, der opfyldte QC-kriterier

18. december 2012

Først opslået (Skøn)

21. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • F1079-P
  • 1I21RX001079-01A (Andet bevillings-/finansieringsnummer: VA ORD RR&D)
  • 1I21RX001079-01 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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