- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00113061
Effect of Exercise on Elevated C-reactive Protein Concentrations in Formerly Inactive Adults
INFLAME: Inflammation and Exercise
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
BACKGROUND:
CRP, a marker of systemic inflammation, has been reported to be an independent predictor of cardiovascular disease in both women and men. Recently published data from cross-sectional analyses showed that CRP is inversely related to cardiorespiratory fitness, and that this association is independent of body mass index. Regular exercise may affect CRP levels, and can possibly be used as a means of reducing elevated CRP levels. Though there are a number of studies focusing on related topics, there are no published reports from randomized clinical trials on the effect of exercise training alone on CRP levels.
DESIGN NARRATIVE:
An estimated 200 individuals will be randomly assigned to either a no exercise control group or an exercise group. Exercising individuals will participate in 3 or 4 training sessions each week for 4 months, and will progress to a total energy expenditure of 16 kcal [kg(-1), week(-1)], which is an exercise dose at the upper end of current public health recommendations for physical activity. The target exercise intensity will be 50-70% of baseline volume of oxygen consumed (V02 max). VO2 max is the maximal rate of oxygen consumption during exercise, and is a measurement of fitness. The primary outcome measure will be plasma CRP concentration. Secondary outcomes will be changes in variables that are potential mechanisms through which regular exercise might reduce CRP. These variables include visceral adiposity, the cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), and heart rate variability as a measure of autonomic balance. Although the primary outcome is CRP level, this study will also contribute significantly to the limited body of literature examining the effect of exercise on the variables of visceral adiposity, cytokines, and heart rate variability.
Tipo de estudio
Inscripción
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
- Pennington Biomedical Research Center, LSU System
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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:
- Physically inactive
- C-reactive protein level at least 2.0 mg/L but less than 10.0 mg/L upon study entry
- Body mass index between 18.5 kg/square meter and 40.0 kg/square meter as measured at study entry
- Does not smoke
- Total cholesterol at least 240 mg/dl with LDL-C at least 160 mg/dl OR LDL less than 190 mg/dl and Framingham less than 10%
- Triglyceride levels no higher than 300 mg/dl
- Fasting glucose level less than 126
- Systolic blood pressure less than 140 mm Hg and/or diastolic blood pressure less than 90 mm Hg as measured at study entry
- If taking an oral contraceptive, aspirin, ibuprofen, or other anti-inflammatory medications, must be on a stable dose for 6 months prior to study entry
- If taking a cholesterol medication, including statins, blood pressure medication (including ace inhibitors), or multi-vitamins, must be on a stable dose for 2 months prior to study entry
Exclusion Criteria:
- Using a beta blocker, hormone replacement therapy, or corticosteroids (except inhalers)
- Any rheumatologic, orthopedic, neurological, or autoimmune diseases, or seizure disorder
- Any significant cardiovascular disease or disorders including, but not limited to, stent or coronary artery bypass grafting
- Cardiac dysrhythmias including, but not limited to, left bundle branch block, atrial fibrillation, pacemaker, or automatic implantable cardioverter defibrillator
- Any surgery, broken bones, blood donation, or anaphylactic shock within 6 months of study entry
- Any sprain or strain, removal of wisdom teeth, or use of antibiotics within 3 months of study entry
- History of stroke or TIA
- History of cancer within at least 5 years of study entry
- Diabetes or glucose intolerance
- Planning on participating in any other research trials during the next year
- Currently pregnant
- Planning to becoming pregnant during the next year
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Plasma CRP concentration (measured at Month 4)
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Medidas de resultado secundarias
Medida de resultado |
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Changes in visceral adiposity, the cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), and heart rate variability (measured at Month 4)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Timothy S. Church, Pennington Biomedical Research Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
- 180
- R01HL075442 (Subvención/contrato del NIH de EE. UU.)
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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