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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01147952
The Effect of Exercise on Peripheral Blood Gene Expression in Angina
A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina
Regular exercise is known to produce significant health benefits and to reduce the risk of heart diseases, although how this benefit occurs is not well understood. White blood cells are known to be involved in triggering heart attacks, and which genes are switched on or off in white blood cells determines whether they have beneficial or harmful effects. Previous studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood gene expression (which reflects white blood cell gene expression) is able to distinguish between patients with and without coronary artery disease, or patients who are able to develop good compared with poor coronary collateral arteries. Therefore, the gene expression signature in peripheral blood may provide novel diagnostic or prognostic information, and insight into the pathogenesis of heart disease.
We therefore hypothesise that exercise alters peripheral blood gene expression in patients with coronary artery disease and angina. This will identify possible ways that exercise improves angina and reduces the risk of heart disease.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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South Yorkshire
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Sheffield, South Yorkshire, Reino Unido, S5 7AU
- NIHR Cardiovascular Biomedical Research Unit
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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:
- Class I to III angina pectoris (classified according to the Canadian Cardiovascular Society [CCS])with documented myocardial ischemia or coronary artery disease on angiography
- Ability to read and speak English to a level allowing satisfactory completion of written questionnaires and to understand instruction during the exercise programme.
Exclusion Criteria:
- Acute coronary syndromes or recent myocardial infarction (<2 months)
- Left main coronary artery stenosis >25% or high-grade proximal left anterior descending artery stenosis
- Known reduced left ventricular function (ejection fraction <40%)
- Significant valvular heart disease
- Insulin-dependent diabetes mellitus
- Occupational, orthopedic, and other conditions that preclude regular exercise
- Patients whose ECG prevents interpretation of an exercise test (LBBB, RBBB, pacemaker implantation).
- Patients who already perform greater than 30min continuous exercise three times weekly (self-reported).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 12 week exercise training
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randomised to 12 weeks of exercise training up to three times weekly.
Training will be interval training with active recovery, with 3 min intervals conducted 10bpm below angina threshold.
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Sem intervenção: Conventional Care
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Peripheral blood gene expression
Prazo: baseline
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baseline
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Peripheral blood gene expression
Prazo: 6wks after starting 12week exercise training (or conventional care)
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6wks after starting 12week exercise training (or conventional care)
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peripheral blood gene expression
Prazo: 12 weeks after exercise training (or conventional care)
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12 weeks after exercise training (or conventional care)
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Peripheral blood gene expression
Prazo: 24 weeks after starting 12 weeks exercise training programme
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24 weeks after starting 12 weeks exercise training programme
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Angina status
Prazo: baseline
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baseline
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Angina status
Prazo: 6wks after starting 12 week exercise programme (or conventional care)
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6wks after starting 12 week exercise programme (or conventional care)
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Angina status
Prazo: 12wks after starting 12 week exercise programme (or conventional care)
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12wks after starting 12 week exercise programme (or conventional care)
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Angina Status
Prazo: 24wks after starting 12 week exercise programme (or conventional care)
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24wks after starting 12 week exercise programme (or conventional care)
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Anxiety Score
Prazo: baseline
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baseline
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Anxiety Score
Prazo: 6wks after starting 12 week exercise programme (or conventional care)
|
6wks after starting 12 week exercise programme (or conventional care)
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Anxiety Score
Prazo: 12wks after starting 12 week exercise programme (or conventional care)
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12wks after starting 12 week exercise programme (or conventional care)
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Anxiety Score
Prazo: 24wks after starting 12 week exercise programme (or conventional care)
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24wks after starting 12 week exercise programme (or conventional care)
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Depression Score
Prazo: 6wks after starting 12 week exercise programme (or conventional care)
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6wks after starting 12 week exercise programme (or conventional care)
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Depression Score
Prazo: baseline
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baseline
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Depression Score
Prazo: 12wks after starting 12 week exercise programme (or conventional care)
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12wks after starting 12 week exercise programme (or conventional care)
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Depression Score
Prazo: 24wks after starting 12 week exercise programme (or conventional care)
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24wks after starting 12 week exercise programme (or conventional care)
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Colaboradores e Investigadores
Patrocinador
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STH15565
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