- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02300064
Exercise in Health and Chronic Obstructive Pulmonary Disease
28 de mayo de 2016 actualizado por: Russell Richardson, University of Utah
Mechanisms of Adaptation to Exercise in Health and Chronic Obstructive Pulmonary Disease (COPD); Oxidative Stress Links Aging, Activity and Mobility
The purpose of this study is to find out more about the effects of chronic obstructive pulmonary disease (COPD) on the function of blood vessels, the heart, and muscle at rest and during exercise.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Oxidative stress, defined as an imbalance between pro and antioxidant molecular species in favor of the former, has recently been recognized as a potential mechanism in the peripheral muscle dysfunction associated with COPD. a series of studies are proposed to better understand the role and source of oxidative stress in the skeletal muscle of patients with COPD.
Specifically, three main aims will address the following questions regarding COPD, skeletal muscle, and oxidative stress: where is oxidative stress most prevalent, why does oxidative stress occur, and what are the consequences of oxidative stress in COPD? the overall hypothesis to be tested is that COPD results in a shift toward greater intramuscular oxidative stress and this is, at least in part, responsible for the diminished mechanical efficiency and greater peripheral muscle fatiguability during muscular work often associated with this disease.
The vascular consequence of this augmented free radical load is altered vascular function and a disruption of the local matching of perfusion and metabolism in skeletal muscle during exercise.
These crucial changes result in a cascade of factors such as local hypoxia and elevated vascular shear stress, entering a vicious cycle that leads to the generation of more free radicals, especially during physical work.
It is proposed that this imbalance between pro and antioxidant potential, toward oxidative stress, plays a significant role in the attenuated exercise capacity and reduced muscle fatigue resistance associated with COPD.
Tipo de estudio
Intervencionista
Inscripción (Actual)
185
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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Utah
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Salt Lake City, Utah, Estados Unidos, 84148
- Veterans Affairs Salt Lake City Heath Care System
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Chronic Obstructive Pulmonary Disease (COPD) patients (over 18 years old) and
- age-matched healthy controls (over 18 years old)
Exclusion Criteria:
- Severe Chronic Obstructive Pulmonary Disease (volume exhaled at the end of the first section of forced expiration is predicted to be under 30 percent),
- Severe Heart Failure
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: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Healthy volunteers
Healthy volunteers will undergo one or more exercise interventions: knee-extensor exercise test; exercise test with restricting/releasing blood flow; exercise test with variable oxygen concentration and MRI; or exercise test with oral antioxidant or placebo cocktail.
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Steady-state, single leg knee-extensor exercise at 20 Watts for 10 minutes
10 minute submaximal (20 Watts) single leg knee-extensor exercise with blood flow clamped 10-15% lower by arterial infustion of phenylephrine; 10 minute passive single leg knee-extensor exercise with blood flow matched to the 20 Watt work rate level by arterial adenosine infusion; 10 minute seated rest with blood flow matched to the 20 Watt work rate level by adenosine infusion.
Each test separated by at least 30 minutes rest.
Two bouts of single leg knee-extensor exercise to maximal effort breathing regular air (21% oxygen) or 100% oxygen through a mouthpiece, with a 90 minute rest period between each bout.
The same experiment performed again on a separate day in an magnetic resonance imaging (MRI) machine
Antioxidants (Vitamin E - 400 international units, Vitamin C - 1000 milligrams and Alpha lipoic acid - 600 milligrams) or matching placebo capsules administered orally followed by femoral nerve stimulation and single leg knee-extensor exercise for 30 minutes at 50% maximum effort
|
|
Experimental: COPD patients
Patients with Chronic Obstructive Pulmonary Disease (COPD) will undergo one or more exercise interventions: knee-extensor exercise test; exercise test with restricting/releasing blood flow; exercise test with variable oxygen concentration and MRI; or exercise test with oral antioxidant or placebo cocktail.
|
Steady-state, single leg knee-extensor exercise at 20 Watts for 10 minutes
10 minute submaximal (20 Watts) single leg knee-extensor exercise with blood flow clamped 10-15% lower by arterial infustion of phenylephrine; 10 minute passive single leg knee-extensor exercise with blood flow matched to the 20 Watt work rate level by arterial adenosine infusion; 10 minute seated rest with blood flow matched to the 20 Watt work rate level by adenosine infusion.
Each test separated by at least 30 minutes rest.
Two bouts of single leg knee-extensor exercise to maximal effort breathing regular air (21% oxygen) or 100% oxygen through a mouthpiece, with a 90 minute rest period between each bout.
The same experiment performed again on a separate day in an magnetic resonance imaging (MRI) machine
Antioxidants (Vitamin E - 400 international units, Vitamin C - 1000 milligrams and Alpha lipoic acid - 600 milligrams) or matching placebo capsules administered orally followed by femoral nerve stimulation and single leg knee-extensor exercise for 30 minutes at 50% maximum effort
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in Free Radical Concentration in Muscle Tissue Following Exercise
Periodo de tiempo: Baseline to two hours
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Baseline to two hours
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in Free Radical Concentration in Muscle Venous Outflow following Exercise
Periodo de tiempo: Baseline to two hours
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Baseline to two hours
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Russell Richardson, Ph.D., US Department of Veterans Affairs
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 2009
Finalización primaria (Actual)
1 de mayo de 2016
Finalización del estudio (Actual)
1 de mayo de 2016
Fechas de registro del estudio
Enviado por primera vez
14 de noviembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
20 de noviembre de 2014
Publicado por primera vez (Estimar)
24 de noviembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
1 de junio de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2016
Última verificación
1 de mayo de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 32404
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. .