- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Normal cycling
Cycling on a residential and downtown route (crossover design)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Change in endothelial function, as measured by peripheral arterial tonometry (EndoPAT) score of reactive hyperemia index (RHI)
Prazo: 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 resultados secundários
Medida de resultado |
Prazo |
---|---|
Change in lung function (using spirometry to assess lung function values)
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Prazo |
---|---|
Change in blood levels of C-reactive protein (a marker of systemic inflammation)
Prazo: 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)
Prazo: 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)
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- H10-00902
- H1008-111481/001/XSB (Outro identificador: UBC CREB)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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