- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01708356
Cycling, Air Pollution and Health (CAPaH)
Introduction: Cycling is currently promoted at the municipal, provincial and national level as a form of active transportation that increases physical activity while at the same time reducing traffic congestion, traffic-related air pollution and greenhouse gas emissions. While at a population level the health benefits of exercise via cycling are estimated to substantially exceed any health impacts related to air pollution exposure and injuries from traffic accidents , cyclists are known to experience elevated exposures to traffic-related air pollutants. Combined with exposure to elevated concentrations of air pollutants, cyclists also are subject to substantially increased inhaled doses due to their level of exertion and consequently increased inhalation rate. Therefore, given that cyclists experience exposures to relatively high concentrations of traffic-related air pollutants and that their inhalation of these pollutants is increased, it is important to evaluate the potential health impacts of this scenario. Research on the potential health impacts related to exercise (cycling) and urban air pollution exposure can help inform public communication strategies related to air quality and its health impacts. In addition, as our previous work suggests substantial variability in air pollution exposures to cyclists that is related to the route type and the levels of traffic along cycling routes, there is potential for transportation planners to promote increased cycling by enhancing infrastructure while at the same time developing routes that also minimize exposure to air pollution. The cyclist population is also interested in information regarding the air pollution exposures and potential health impacts related to cycling.
The objective of this study is to investigate the relationship between traffic-related air pollution exposure, and respiratory and cardiovascular health impacts in commuting cyclists. Specifically, the investigators propose to:
- determine commuting cyclists' exposure to traffic-related air pollutants (PM 2.5, PM10, ultrafine particulate, black carbon) while cycling along two different bicycle routes in the city of Vancouver;
- estimate the pollutant dose received by each cyclist, and relate this to the health effects observed; and
- determine if there is a change in lung function, endothelial function, and C-reactive protein level related to the level of air pollution exposure and dose
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z3
- Air Pollution Exposure Lab, Vancouver General Hospital through the School of Population and Public Health, University of British Columbia
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 19- 39
- male or female
- able to bicycle comfortably on city streets for 1 hour
Exclusion Criteria:
- Smokers of any substance (smoking more than 1x every 2 weeks)
- Must be of height to safely ride a test bike (<5'2", >6'5" )
- Diagnosed asthma or active allergy (hav fever) symptoms
- Irregular menstrual cycle, pregnant, breastfeeding, non-monocyclic contraceptive medication or device
- Taking medication for heart or lung condition
- Answers yes to any questions on physical activity readiness questionnaire (PAR-Q)
- requires pain medication daily
- visual or hearing impairment that prevents safe cycling on streets with motor vehicles
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Normal cycling
Cycling on a residential and downtown route (crossover design)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in endothelial function, as measured by peripheral arterial tonometry (EndoPAT) score of reactive hyperemia index (RHI)
Tidsramme: Baseline (1 hour pre-expousre) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
|
Baseline (1 hour pre-expousre) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in lung function (using spirometry to assess lung function values)
Tidsramme: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
|
Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in blood levels of C-reactive protein (a marker of systemic inflammation)
Tidsramme: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
|
Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
|
Change in blood levels of Interleukin-6 (a marker of systemic inflammation)
Tidsramme: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
|
Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
|
Change in blood levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG)(a marker of oxidative stress)
Tidsramme: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
|
Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Michael Brauer, ScD, The University of British Columbia
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- H10-00902
- H1008-111481/001/XSB (Anden identifikator: UBC CREB)
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 .
Kliniske forsøg med Endotel dysfunktion
-
IVI MadridAfsluttetVaskulær endothelial vækstfaktor overekspression
-
Centre Hospitalier Régional Metz-ThionvilleAfsluttetDescemets Stripping Automated Endothelial Keratoplasty
-
IVI BilbaobTI VitoriaAfsluttetVaskulær endothelial vækstfaktor overekspressionSpanien
-
Al-Azhar UniversityAfsluttetVaskulær endothelial vækstfaktor overekspression | Membrane AlterationEgypten
-
Stimdia Medical, Inc.AfsluttetVentilator-induceret diaphragmatic dysfunction (VIDD)Irland, Tjekkiet
-
Oslo University HospitalRekrutteringDescemet Stripping Automated Endothelial Keratoplasty (DSAEK) | Descemet Membrane Endothelial Keratoplasty (DMEK)Norge
-
Heinrich-Heine University, DuesseldorfAfsluttetPerifer blod mononukleær celle | Rød blodcelle | Endothelial NO-syntaseTyskland
-
University of East AngliaAfsluttetEicosapentaensyre | Kardiovaskulære fysiologiske fænomener | Endothelial nitrogenoxidsyntase | Docosahexaensyre (All-Z-isomer)Det Forenede Kongerige
-
Nationwide Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutteringPædiatrisk Sepsis-induceret Multiple Organ Dysfunction SyndromeForenede Stater
-
University of WaterlooAfsluttetMeibomian Gland Dysfunction (MGD)Canada
Kliniske forsøg med Cycling on a residential route
-
Academia Sinica, TaiwanNational Health Research Institutes, TaiwanIkke rekrutterer endnuOvervægt og fedme
-
Onconova Therapeutics, Inc.AfsluttetAvanceret solid tumor | HepatomForenede Stater
-
elbion AGAfsluttet
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)UkendtKastrationsresistent prostatakarcinom | Metastatisk prostatakarcinom | Stadie IVB prostatakræft AJCC v8 | Kastrationsniveauer af testosteron | Prostatakarcinom Metastatisk i knoglerneForenede Stater
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk bugspytkirteladenokarcinom | Stadie IV Bugspytkirtelkræft AJCC v6 og v7 | Fase IV kolorektal cancer AJCC v7 | Stage IVA tyktarmskræft AJCC v7 | Fase IVB tyktarmskræft AJCC v7 | Metastatisk Gastroøsofageal Junction Adenocarcinoma | Metastatisk kolorektalt karcinom | Metastatisk malignt fordøjelsessystemet... og andre forholdForenede Stater
-
Thomas Jefferson UniversityAbbVieRekrutteringMyelodysplastisk syndrom | Tilbagevendende myelodysplastisk syndrom | Refraktært myelodysplastisk syndromForenede Stater
-
National Cancer Institute (NCI)AfsluttetStadie IV Ovariekimcelletumor | Tilbagevendende kimcelletumor i æggestokkene | Stadie III testikelkræft | Tilbagevendende malign testikel-kimcelletumor | Tilbagevendende ekstragonadal seminom | Tilbagevendende malign ekstragonadal kimcelletumor | Tilbagevendende malign ekstragonadal ikke-seminomatøs... og andre forholdForenede Stater
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityAfsluttetPrimær myelofibrose | Anæmi | Tilbagevendende Hodgkin-lymfom | Refraktært Hodgkin-lymfom | Anatomisk fase IV brystkræft AJCC v8 | Tilbagevendende akut myeloid leukæmi | Tilbagevendende myelodysplastisk syndrom | Refraktær akut myeloid leukæmi | Refraktær kronisk myelomonocytisk leukæmi | Refraktært myelodysplastisk... og andre forholdForenede Stater
-
Sidney Kimmel Cancer Center at Thomas Jefferson...AfsluttetAdenocarcinom i bugspytkirtlen | Uoperabelt pancreascarcinom | Tilbagevendende pancreascarcinom | Stadie III Bugspytkirtelkræft | Stadie IV BugspytkirtelkræftForenede Stater
-
Mayo ClinicNational Cancer Institute (NCI)RekrutteringTilbagevendende Hodgkin-lymfom | Kronisk myelomonocytisk leukæmi | Refraktær lymfom | Tilbagevendende diffust stort B-cellet lymfom | Refraktært diffust stort B-cellet lymfom | Tilbagevendende lymfom | Klonal cytopeni af ubestemt betydning | Højgradig B-celle lymfom med MYC og BCL2 eller BCL6 omlejringerForenede Stater