- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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British Columbia
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Vancouver, British Columbia, Canadá, V6T 1Z3
- Air Pollution Exposure Lab, Vancouver General Hospital through the School of Population and Public Health, University of British Columbia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Normal cycling
Cycling on a residential and downtown route (crossover design)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in endothelial function, as measured by peripheral arterial tonometry (EndoPAT) score of reactive hyperemia index (RHI)
Periodo de tiempo: Baseline (1 hour pre-expousre) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
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Baseline (1 hour pre-expousre) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in lung function (using spirometry to assess lung function values)
Periodo de tiempo: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
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Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in blood levels of C-reactive protein (a marker of systemic inflammation)
Periodo de tiempo: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
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Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
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Change in blood levels of Interleukin-6 (a marker of systemic inflammation)
Periodo de tiempo: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
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Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
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Change in blood levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG)(a marker of oxidative stress)
Periodo de tiempo: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
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Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael Brauer, ScD, The University of British Columbia
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- H10-00902
- H1008-111481/001/XSB (Otro identificador: UBC CREB)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .