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- Ensayo clínico NCT01478334
Exercise-induced Improvements of Inflammatory Status in Patients With Rheumatoid Arthritis
Exercise-induced Improvements of Inflammatory Status in Patients With Rheumatoid Arthritis - Improvements of Cardiovascular Risk Factors and Quality of Life
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Rheumatoid arthritis (RA) is a chronic, systemic inflammatory disorder that may affect many tissues and organs, but principally attacks synovial joints. Although the cause of rheumatoid arthritis is unknown, autoimmunity plays a role in both the chronicity and progression, and RA is considered as a systemic autoimmune disease.
Due to chronic inflammatory status, RA-patients are at higher risk of developing cardiovascular disease (CVD) compared to the general population. Accumulating evidence indicates that regular physical activity has beneficial effects on RA. The mechanisms behind exercise-induce improvements are none the less unclear and more research is needed to better understand the beneficial effects of exercise training in this patient group.
Recently, promising results from gene expression studies of blood cells have revealed unexplored fields of biomarker discovery and gene expression profiling of disease. Due to easy accessible and minimally invasive sample collection, gene expression profiling of whole blood might turn out to be a promising tool in molecular diagnostics and clinical medicine. To our knowledge, whole-genome transcriptional changes have not previously been studied in RA-patients undergoing a high-intensity exercise program.
Hypothesis: Ten weeks of high intensity interval training improves the inflammatory status, quality of life, and known risk factors for cardiovascular diseases.
In addition to measure traditionally inflammatory markers in the blood, whole genome analysis will be made.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Trondheim, Noruega, 7006
- Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,
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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:
- Ability to exercise
- written consent
Exclusion Criteria:
- Inability to exercise
- Known ischemic cardiovascular disease
- Severe pulmonary disease
- High activity level
- Pregnancy
- drug/alcohol abuse
- Unstable RA
- diagnosis before 2000
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Exercise then control
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First 10 week of high intensity interval training, twice a week. The interval training session consists of 10 minutes warm up at 70 percent of maximal heart rate and continues with 4 times 4 minutes of high intensity intervals at 90 to 95 percent of maximal heart rate separated by 3 minutes of active brakes in between at 70 percent of maximal heart rate. Training will be performed by cycling. Training intensity will be supervised through the use of polar puls monitors and the BORG scale of subjective perceived exhaustion. Second 10 weeks participants are instructed not to change their dietary patterns or physical activity levels during the study period. |
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Experimental: Control then exercise
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First 10 weeks participants are instructed not to change their dietary patterns or physical activity levels, and to continue their habitually lifestyle. Second 10 week of high intensity interval training, twice a week. The interval training session consists of 10 minutes warm up at 70 percent of maximal heart rate and continues with 4 times 4 minutes of high intensity intervals at 90 to 95 percent of maximal heart rate separated by 3 minutes of active brakes in between at 70 percent of maximal heart rate. Training will be performed by cycling. Training intensity will be supervised through the use of polar puls monitors and the BORG scale of subjective perceived exhaustion. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Inflammatory markers in blood
Periodo de tiempo: 10 weeks
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C-reactive Protein (CRP), TNF-alfa, COMP, Pentraxin 3 using ELISA Whole-genome gene expression in blood cells using RNA(HumanHT-12 v4 Expression BeadChip)
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10 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Endothelial function
Periodo de tiempo: 10 weeks
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Flow mediated dilatation (FMD).
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10 weeks
|
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quality of life
Periodo de tiempo: 10 weeks
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Questionnaire SF-36
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10 weeks
|
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HDL
Periodo de tiempo: 10 weeks
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Standard biochemical analysis procedure at St.Olavs hospital
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10 weeks
|
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Total Cholesterol
Periodo de tiempo: 10 weeks
|
Standard biochemical analysis procedure at St.Olavs hospital
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10 weeks
|
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Blood glucose
Periodo de tiempo: 10 weeks
|
Standard biochemical analysis procedure at St.Olavs hospital
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10 weeks
|
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whole-genome gene expression in blood cells
Periodo de tiempo: 10 weeks
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total RNA isolated from whole blood (Qiagen, Bioanalyzer, NanoDrop).
Gene expression analysis on HumanHT-12 v4 Expression BeadChip.
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10 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Dorthe Stensvold
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
- RA-2011
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