- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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Sin intervención: Conventional Care
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Peripheral blood gene expression
Periodo de tiempo: baseline
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baseline
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Peripheral blood gene expression
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Angina status
Periodo de tiempo: baseline
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baseline
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Angina status
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: baseline
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baseline
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Anxiety Score
Periodo de tiempo: 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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Anxiety Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: baseline
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baseline
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Depression Score
Periodo de tiempo: 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
Periodo de tiempo: 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
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STH15565
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
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