- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01728675
Eccentric Exercise and Oxidative Stress
13 de noviembre de 2012 actualizado por: Dr. Anastasios Theodorou, European University Cyprus
The Effect of Eccentric Exercise on Oxidative Stress in the Elderly
The purpose of the present investigation is to compare the responses and adaptations of young and elderly individuals to repeated eccentric exercise in regards to muscle function and redox homeostasis in a side-by-side comparison.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Despite the progress of analytic techniques and the refinement of study designs, striking disagreement exists among studies regarding the influence of exercise on muscle function and redox homeostasis in the elderly.
A specific exercise protocol will be applied (the repeated eccentric model) to produce long-lasting and extensive changes in redox biomarkers and to examine more easily the potential effects of aging.
Ten young men and ten elderly men will underwent an isokinetic eccentric exercise session, which will be repeated after three weeks.
Muscle function indices and redox biomarkers will be assessed in urine, plasma or erythrocytes pre exercise, immediately post exercise, 2 and 4 days post exercise.
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
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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Nicosia, Chipre, 1516
- European University Cyprus
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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 a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- subject provides written informed consent
- physiological health profile
- stable at their anthropometric characteristics for at least the last year
Exclusion Criteria:
- muscle disease
- prior history of musculoskeletal injury to the lower limbs
- smokers
- consumed any nutritional supplement the last 3 months
- performed intense eccentric exercise the last 6 months
- non Caucasian
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: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Young group
Participants will underwent two isokinetic eccentric exercise sessions
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Participants will perform two isokinetic eccentric exercise bouts
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Experimental: Elderly group
Participants will underwent two isokinetic eccentric exercise sessions
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Participants will perform two isokinetic eccentric exercise bouts
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Muscle torque (torque)
Periodo de tiempo: Change in muscle torque from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in muscle torque from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Range of motion, ROM (degrees)
Periodo de tiempo: Change in ROM from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in ROM from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Delayed onset muscle soreness, DOMS (scale 1-10)
Periodo de tiempo: Change in DOMS from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in DOMS from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Creatine kinase, CK (activity IU)
Periodo de tiempo: Change in CK from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in CK from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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F2-isoprostanes (pg/mg creatinine)
Periodo de tiempo: Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Protein carbonyls (nmol/mg protein)
Periodo de tiempo: Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Glutathione, GSH (μmol/g Hb)
Periodo de tiempo: Change in GSH from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in GSH from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Catalase (U/g Hb)
Periodo de tiempo: Change in catalase from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in catalase from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Superoxide dismutase, SOD (U/g Hb)
Periodo de tiempo: Change in SOD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in SOD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Glutathione peroxidase, GPx (U/g Hb)
Periodo de tiempo: Change in GPx from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in GPx from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Glucose-6-phosphate dehydrogenase, G6PD (U/g Hb)
Periodo de tiempo: Change in G6PD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in G6PD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Uric acid (mM)
Periodo de tiempo: Change in uric acid from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in uric acid from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Albumin (μM)
Periodo de tiempo: Change in albumin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in albumin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Bilirubin (μM)
Periodo de tiempo: Change in bilirubin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in bilirubin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Michalis G Nikolaidis, PhD, Aristotle University Of Thessaloniki
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
- Nikolaidis MG, Kyparos A, Vrabas IS. F(2)-isoprostane formation, measurement and interpretation: the role of exercise. Prog Lipid Res. 2011 Jan;50(1):89-103. doi: 10.1016/j.plipres.2010.10.002. Epub 2010 Oct 15.
- Nikolaidis MG, Jamurtas AZ. Blood as a reactive species generator and redox status regulator during exercise. Arch Biochem Biophys. 2009 Oct 15;490(2):77-84. doi: 10.1016/j.abb.2009.08.015. Epub 2009 Aug 25.
- Nikolaidis MG, Kyparos A, Spanou C, Paschalis V, Theodorou AA, Vrabas IS. Redox biology of exercise: an integrative and comparative consideration of some overlooked issues. J Exp Biol. 2012 May 15;215(Pt 10):1615-25. doi: 10.1242/jeb.067470.
- Theodorou AA, Nikolaidis MG, Paschalis V, Sakellariou GK, Fatouros IG, Koutedakis Y, Jamurtas AZ. Comparison between glucose-6-phosphate dehydrogenase-deficient and normal individuals after eccentric exercise. Med Sci Sports Exerc. 2010 Jun;42(6):1113-21. doi: 10.1249/MSS.0b013e3181c67ecd.
- Panayiotou G, Paschalis V, Nikolaidis MG, Theodorou AA, Deli CK, Fotopoulou N, Fatouros IG, Koutedakis Y, Sampanis M, Jamurtas AZ. No adverse effects of statins on muscle function and health-related parameters in the elderly: an exercise study. Scand J Med Sci Sports. 2013 Oct;23(5):556-67. doi: 10.1111/j.1600-0838.2011.01437.x. Epub 2012 Jan 31.
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 mayo de 2012
Finalización primaria (Actual)
1 de julio de 2012
Finalización del estudio (Actual)
1 de julio de 2012
Fechas de registro del estudio
Enviado por primera vez
6 de noviembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
13 de noviembre de 2012
Publicado por primera vez (Estimar)
20 de noviembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de noviembre de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
13 de noviembre de 2012
Última verificación
1 de noviembre de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- EUC-017
- EUC-019 (Otro número de subvención/financiamiento: European University Cyprus)
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. .