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- Ensayo clínico NCT02875522
The Effects of Aerobic Exercise Training on Vascular, Cardiac and Cerebral Vascular Function in COPD
17 de agosto de 2016 actualizado por: University of British Columbia
The Effects of Aerobic Exercise Training on Peripheral Vascular, Cardiac and Cerebral Vascular Function in Patients With Chronic Obstructive Pulmonary Disease
The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to inflammation in the lungs and blood vessels that can lead to secondary problems such as blood vessel disease, high blood pressure and heart disease.
Aerobic exercise training has been shown to reduce the risk of heart and brain disease; however, it is currently unknown whether exercise training can have the same affect in patients with COPD.
The aim of this study is to investigate how eight weeks of aerobic exercise training improves blood vessel and heart function and brain blood flow in patients with COPD.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic obstructive pulmonary disease (COPD) is a treatable respiratory condition that is only partially reversible.
The primary cause of COPD is smoking which leads to airway inflammation and oxidative damage to the lungs, which has been linked to the development and progression of the disease.
The inflammation is not isolated to the lungs as patients with COPD also have systemic inflammation that has been linked to a number of cardiovascular comorbidities such as endothelial dysfunction, cardiovascular disease and stroke.
Evidence demonstrates that COPD patients have a greater incidence of vascular dysfunction and adverse vascular remodeling, which worsens with disease severity.
In fact, patients with COPD are at 35 times greater risk of developing cardiovascular disease and stroke than healthy aged matched individuals.
In healthy individuals and a number of chronic conditions, aerobic exercise training is well established to reduce the risk of cardiovascular and cerebrovascular disease.
The benefits of exercise are likely through improvements in endothelial function, systemic inflammation, and cardiac and cerebral vascular function.
However, whether exercise training can have the same effects in a chronic inflammatory condition like COPD has not been studied.
The purpose of this study is to determine the effectiveness of an 8 week aerobic exercise training program in patient's chronic obstructive pulmonary disease as determined by improvements in endothelial function, systemic inflammation and cardiac and cerebral vascular function.
Tipo de estudio
Intervencionista
Inscripción (Actual)
58
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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British Columbia
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Kelowna, British Columbia, Canadá, V1V 1V7
- University of British Columbia
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Non-smokers (>6 months);
- Forced expiratory volume in one second/ forced vital capacity (FEV1/FVC) < 0.7 and FEV1/FVC <lower limit of normal
- Stable (>3 months exacerbation free)
Exclusion Criteria:
- On supplemental oxygen;
- Known cardiac or cerebral vascular disease, diabetes, obstructive sleep apnea;
- Uncontrolled hypertension;
- BMI >30kg/m2
- Currently performing pulmonary rehabilitation or structured exercise training;
- Desaturate during exercise (SpO2<85%)
- Cardiovascular contraindications to exercise in the incremental test used for screening
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Patients with COPD
Stable patients with COPD participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.
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Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank.
Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation
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Comparador activo: Healthy Controls
Age, sex, BMI and activity matched controls participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.
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Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank.
Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Endothelial Function
Periodo de tiempo: 8-weeks (following 24 sessions of exercise training)
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The change in brachial artery flow mediated dilation measured using reactive hyperaemia
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8-weeks (following 24 sessions of exercise training)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Arterial Stiffness
Periodo de tiempo: 8-weeks (following 24 sessions of exercise training)
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The change in pulse wave velocity measured using tonometry
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8-weeks (following 24 sessions of exercise training)
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Carotid intima-medial thickness
Periodo de tiempo: 8-weeks (following 24 sessions of exercise training)
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The change in carotid intima-medial thickness measured by ultrasound
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8-weeks (following 24 sessions of exercise training)
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Carotid Compliance
Periodo de tiempo: 8-weeks (following 24 sessions of exercise training)
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The change in carotid compliance measured using tonometry and ultrasound for the carotid arteries
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8-weeks (following 24 sessions of exercise training)
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Inflammatory Biomarkers
Periodo de tiempo: 8-weeks (following 24 sessions of exercise training)
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The change in serum levels of CRP, IL-6, IL-10 and TNF-alpha measured using Luminex multiplex bead-based technology
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8-weeks (following 24 sessions of exercise training)
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Systolic function
Periodo de tiempo: 8-weeks (following 24 sessions of exercise training)
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The change in stroke volume using echocardiography
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8-weeks (following 24 sessions of exercise training)
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Diastolic function
Periodo de tiempo: 8-weeks (following 24 sessions of exercise training)
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The change in left ventricular end-diastolic volume using echocardiography
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8-weeks (following 24 sessions of exercise training)
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Cerebral Blood Flow
Periodo de tiempo: 8-weeks (following 24 sessions of exercise training)
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The change in cerebral and neck blood flow using ultrasound
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8-weeks (following 24 sessions of exercise training)
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Cerebrovascular Reactivity
Periodo de tiempo: 8-weeks (following 24 sessions of exercise training)
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The change in middle cerebral artery velocity in response to carbon dioxide
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8-weeks (following 24 sessions of exercise training)
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Cerebrovascular Autoregulation
Periodo de tiempo: 8-weeks (following 24 sessions of exercise training)
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The change in phase delay measured by transfer function analysis
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8-weeks (following 24 sessions of exercise training)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Neil Eves, PhD, University of British Columbia
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Gelinas JC, Lewis NC, Harper MI, Ainslie PN, Rolf JD, Eves ND. Aerobic Exercise Training on Peripheral Vascular Structure and Function in Patients with Chronic Obstructive Pulmonary Disease. American Journal of Respiratory and Critical Care Medicine, 191:A5305, 2015.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2012
Finalización primaria (Actual)
1 de mayo de 2015
Finalización del estudio (Actual)
1 de mayo de 2015
Fechas de registro del estudio
Enviado por primera vez
4 de agosto de 2016
Primero enviado que cumplió con los criterios de control de calidad
17 de agosto de 2016
Publicado por primera vez (Estimar)
23 de agosto de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
23 de agosto de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2016
Última verificación
1 de agosto de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H11-02770
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. .