Q3142944 (Q3142944): Difference between revisions
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(Created claim: summary (P836): The main objective is to check the non-inferiority of supervised physical exercise versus antidepressant treatment in reducing the depressive symptoms of patients with clinical criteria of depressive episode (IED 10) over a follow-up period of 6 months. This is a randomised clinical trial conducted in Primary Care in which a total of 312 patients over 65 years of age with clinically significant depression will be randomly assigned to a supervis...) |
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The main objective is to check the non-inferiority of supervised physical exercise versus antidepressant treatment in reducing the depressive symptoms of patients with clinical criteria of depressive episode (IED 10) over a follow-up period of 6 months. This is a randomised clinical trial conducted in Primary Care in which a total of 312 patients over 65 years of age with clinically significant depression will be randomly assigned to a supervised physical exercise program or will receive treatment with antidepressants commonly used in clinical practice. Initially, the physical fitness of the participants will be evaluated and evaluations will be carried out after 15 days, 1, 3 and 6 months. The supervised exercise program will consist of 2 sessions per week in groups of 10-12 patients over a 6-month period in which a sports monitor will train patients to perform at least 30 minutes of moderate-intensity regular activity with an almost daily frequency, including aerobic exercise and muscle strengthening, flexibility, and balance exercises. In both groups, the status of depressive symptoms, level of physical activity, self-perception of health status, occurrence of adverse effects and adherence to the exercise program or antidepressant treatment will be periodically evaluated, among other variables. The main outcome variable will be the reduction of pre-treatment score on depressive symptom scales (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale). (English) | |||||||||||||||
| Property / summary: The main objective is to check the non-inferiority of supervised physical exercise versus antidepressant treatment in reducing the depressive symptoms of patients with clinical criteria of depressive episode (IED 10) over a follow-up period of 6 months. This is a randomised clinical trial conducted in Primary Care in which a total of 312 patients over 65 years of age with clinically significant depression will be randomly assigned to a supervised physical exercise program or will receive treatment with antidepressants commonly used in clinical practice. Initially, the physical fitness of the participants will be evaluated and evaluations will be carried out after 15 days, 1, 3 and 6 months. The supervised exercise program will consist of 2 sessions per week in groups of 10-12 patients over a 6-month period in which a sports monitor will train patients to perform at least 30 minutes of moderate-intensity regular activity with an almost daily frequency, including aerobic exercise and muscle strengthening, flexibility, and balance exercises. In both groups, the status of depressive symptoms, level of physical activity, self-perception of health status, occurrence of adverse effects and adherence to the exercise program or antidepressant treatment will be periodically evaluated, among other variables. The main outcome variable will be the reduction of pre-treatment score on depressive symptom scales (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale). (English) / rank | |||||||||||||||
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| Property / summary: The main objective is to check the non-inferiority of supervised physical exercise versus antidepressant treatment in reducing the depressive symptoms of patients with clinical criteria of depressive episode (IED 10) over a follow-up period of 6 months. This is a randomised clinical trial conducted in Primary Care in which a total of 312 patients over 65 years of age with clinically significant depression will be randomly assigned to a supervised physical exercise program or will receive treatment with antidepressants commonly used in clinical practice. Initially, the physical fitness of the participants will be evaluated and evaluations will be carried out after 15 days, 1, 3 and 6 months. The supervised exercise program will consist of 2 sessions per week in groups of 10-12 patients over a 6-month period in which a sports monitor will train patients to perform at least 30 minutes of moderate-intensity regular activity with an almost daily frequency, including aerobic exercise and muscle strengthening, flexibility, and balance exercises. In both groups, the status of depressive symptoms, level of physical activity, self-perception of health status, occurrence of adverse effects and adherence to the exercise program or antidepressant treatment will be periodically evaluated, among other variables. The main outcome variable will be the reduction of pre-treatment score on depressive symptom scales (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale). (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 14:05, 12 October 2021
Project Q3142944 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | No label defined |
Project Q3142944 in Spain |
Statements
41,200.0 Euro
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51,500.0 Euro
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80.0 percent
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1 January 2016
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31 March 2020
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FUNDACION DEL HOSPITAL NACIONAL DE PARAPLEJICOS
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38°59'42.32"N, 1°51'21.31"W
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02003
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El objetivo principal es comprobar la no inferioridad del ejercicio físico supervisado frente al tratamiento antidepresivo en la reducción de los síntomas depresivos de pacientes con criterios clínicos de episodio depresivo (CIE 10) a lo largo de un periodo de seguimiento de 6 meses. Se trata de un ensayo clínico aleatorizado realizado en Atención Primaria en el que un total de 312 pacientes mayores de 65 años con depresión clínicamente significativa serán asignados aleatoriamente a un programa de ejercicio físico supervisado o bien recibirán tratamiento con fármacos antidepresivos utilizados habitualmente en la práctica clínica. Inicialmente se evaluará la aptitud física de los participantes y se realizarán evaluaciones al cabo de 15 días y 1, 3 y 6 meses. El programa de ejercicio supervisado consistirá en 2 sesiones semanales en grupos de 10-12 pacientes durante un periodo de 6 meses en las que un monitor deportivo adiestrará a los pacientes para realizar al menos 30 minutos de actividad regular de intensidad moderada con una frecuencia casi diaria, incluyendo ejercicio aeróbico y ejercicios de fortalecimiento muscular, flexibilidad y equilibrio. En ambos grupos se evaluará periódicamente, entre otras variables, el estado de los síntomas depresivos, nivel de actividad física, autopercepción del estado de salud, aparición de efectos adversos y adherencia al programa de ejercicio físico o al tratamiento antidepresivo. La principal variable de resultado será la reducción de la puntuación previa al tratamiento en las escalas de síntomas depresivos (Montgomery-Asberg Depression Rating Scale y Geriatric Depression Scale). (Spanish)
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The main objective is to check the non-inferiority of supervised physical exercise versus antidepressant treatment in reducing the depressive symptoms of patients with clinical criteria of depressive episode (IED 10) over a follow-up period of 6 months. This is a randomised clinical trial conducted in Primary Care in which a total of 312 patients over 65 years of age with clinically significant depression will be randomly assigned to a supervised physical exercise program or will receive treatment with antidepressants commonly used in clinical practice. Initially, the physical fitness of the participants will be evaluated and evaluations will be carried out after 15 days, 1, 3 and 6 months. The supervised exercise program will consist of 2 sessions per week in groups of 10-12 patients over a 6-month period in which a sports monitor will train patients to perform at least 30 minutes of moderate-intensity regular activity with an almost daily frequency, including aerobic exercise and muscle strengthening, flexibility, and balance exercises. In both groups, the status of depressive symptoms, level of physical activity, self-perception of health status, occurrence of adverse effects and adherence to the exercise program or antidepressant treatment will be periodically evaluated, among other variables. The main outcome variable will be the reduction of pre-treatment score on depressive symptom scales (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale). (English)
12 October 2021
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Albacete
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Identifiers
PI15_01486
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