Computerized Cognitive Training for the Elderly
12 de enero de 2018 actualizado por: Rogerio Panizzutti, Universidade Federal do Rio de Janeiro
The purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for the elderly
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Cognitive impairments are prominent features of aging and are mostly characterized by memory difficulties. Neuroplasticity based computerized cognitive trainings have been emerging for the last two decades and are an attempt to help the elderly population with their impairments.
The aim of this study is to perform a computerized cognitive training to improve attention, concentration, learning, and quality of life in elderly participants. The investigators are interested in testing the differential efficacy between a bottom-up to top-down versus a top-down to bottom-up computerized cognitive training.
The investigators will conduct a 40 hours computerized, adaptable, cognitive training program in participants 60 years of age and above. Participants will come for 1 hour, daily, and perform a bottom-up to top-down or top-down to bottom-up training, or control games for about 2 months. Bottom-up to top-down and top-down to bottom-up exercises are chosen to target cognitive domains such as divided and selective attention, short-term and working memory, orientation skills and social cognition. Cognitive and emotional data will be collected before the training, half way through, and after the training, to assess progress in several aspects of their functioning.
The investigators hypothesize bottom-up to top-down and top-down to bottom-up trainings will be effective as compared to the control games. They also expect that bottom-up to top-down training to be more efficient compared to top-down to bottom-up training because the first targets more basic cognitive functions which then allows triggering higher cognitive functions, reaching optimal cognitive performance levels more rapidly, where as the second may start with a too high demand on cognitive functions, which may compromise participants ability to reach optimal levels of cognitive performance as fast as the first type of training, if they do not have the "bottom-up lever" first. The investigators also hypothesize that both trainings will improve quality of life.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
150
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.
Estudio Contacto
- Nombre: Rogério Panizzutti, M.D, PhD
- Número de teléfono: +552139386390
- Correo electrónico: rogerio@icb.ufrj.br
Copia de seguridad de contactos de estudio
- Nombre: Linda Scoriels, PhD
- Número de teléfono: +552139385588
- Correo electrónico: lindascor@yahoo.fr
Ubicaciones de estudio
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RJ
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Rio de Janeiro, RJ, Brasil, 21941590
- Reclutamiento
- Federal University of Rio de Janeiro
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Contacto:
- Linda Scoriels, Ph.D.
- Número de teléfono: +552139385588
- Correo electrónico: lindascor@yahoo.fr
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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
60 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- age above 60 years old; Portuguese as main language (learned before 12 years of age); Mini Mental State Examination above 26 points;
Exclusion Criteria:
- Intellectual Quotient below 70; serious medical or neurological condition preventing from participation in the study; substance abuse (according to Diagnostic and Statistical Manual of mental disorders-IV criteria).
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Bottom-up to top-down cognitive training
Participants are given 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes
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40 hours of a computerized cognitive training, given 1 hour daily
Otros nombres:
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Comparador activo: Top-down to bottom-up cognitive training
Participants are given 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes
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40 hours of a computerized cognitive training, given 1 hour daily
Otros nombres:
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Comparador de placebos: Computer games
Participants are given 40 hours of computer games commonly found on the internet and which do not involve a high demand in cognitive functions (e.g.
fishing game, pinball game, tetris, etc).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Global cognition score change
Periodo de tiempo: through study completion, an average of 1 year
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An average of all the cognitive measures will be done to calculate the global cognition score and change will be made between endpoint and midpoint and midpoint and baseline
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through study completion, an average of 1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Processing speed score change
Periodo de tiempo: through study completion, an average of 1 year
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Processing speed score will be measured using the identification task from Cogstate tests battery
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through study completion, an average of 1 year
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Attention score change
Periodo de tiempo: through study completion, an average of 1 year
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Attention score will be measured using the detection task from Cogstate tests battery
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through study completion, an average of 1 year
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Concentration score change
Periodo de tiempo: through study completion, an average of 1 year
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Concentration score will be measured using the Trail Making Test
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through study completion, an average of 1 year
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Short-term memory score change
Periodo de tiempo: through study completion, an average of 1 year
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Short- term memory score will be measured using the Rey Auditory-Verbal learning test
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through study completion, an average of 1 year
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long-term memory score change
Periodo de tiempo: through study completion, an average of 1 year
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long- term memory score will be measured using the Rey Auditory-Verbal learning test
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through study completion, an average of 1 year
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learning score change
Periodo de tiempo: through study completion, an average of 1 year
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learning score will be measured using the Rey Auditory-Verbal learning test
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through study completion, an average of 1 year
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working memory score change
Periodo de tiempo: through study completion, an average of 1 year
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working memory score will be measured using the 1-back and 2-back tasks from the Cogstate tests battery
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through study completion, an average of 1 year
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Semantic memory score change
Periodo de tiempo: through study completion, an average of 1 year
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semantic memory score will be measured using the Verbal fluency test
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through study completion, an average of 1 year
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Cognitive flexibility score change
Periodo de tiempo: through study completion, an average of 1 year
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Cognitive flexibility score will be measured using the Set shifting task from the Cogstate tests battery
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through study completion, an average of 1 year
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social cognition score change
Periodo de tiempo: through study completion, an average of 1 year
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Social cognition score will be measured using the Social-Emotional Cognition task from the Cogstate tests battery
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through study completion, an average of 1 year
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Depression score change
Periodo de tiempo: through study completion, an average of 1 year
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Depression score will be measured using the Geriatric Depression Scale
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through study completion, an average of 1 year
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Instrumental activity of daily living score change
Periodo de tiempo: through study completion, an average of 1 year
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Instrumental activity of daily living score will be measured using the Lawton instrumental activity of daily living scale
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through study completion, an average of 1 year
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Independence in activities of daily living score change
Periodo de tiempo: through study completion, an average of 1 year
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Independence in activities of daily living score will be measured using the Katz Independence in activities of daily living scale
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through study completion, an average of 1 year
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Functional status score change
Periodo de tiempo: through study completion, an average of 1 year
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Functional status score will be measured using the Direct Assessment of Functional Status questionnaire
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through study completion, an average of 1 year
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Timed instrumental activities of daily living score change
Periodo de tiempo: through study completion, an average of 1 year
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Timed instrumental activities of daily living score will be measured using the Timed instrumental activities of daily living scale
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through study completion, an average of 1 year
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Physical activity score change
Periodo de tiempo: through study completion, an average of 1 year
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Physical activity score will be measured using the International Physical Activity Questionnaire
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through study completion, an average of 1 year
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Praxis score change
Periodo de tiempo: through study completion, an average of 1 year
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Praxis score will be measured using the Cambridge Cognition Examination test
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through study completion, an average of 1 year
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Episodic memory score change
Periodo de tiempo: through study completion, an average of 1 year
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Episodic memory score will be measured using the Cambridge Cognition Examination test
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through study completion, an average of 1 year
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Quality of life score change
Periodo de tiempo: through study completion, an average of 1 year
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Quality of life will be assessed with the World Health Organization Quality of Life questionnaire
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through study completion, an average of 1 year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Rogério Panizzutti, M.D, PhD, Universidade Federal do Rio de Janeiro
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 2014
Finalización primaria (Anticipado)
1 de diciembre de 2018
Finalización del estudio (Anticipado)
1 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
14 de diciembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
15 de diciembre de 2015
Publicado por primera vez (Estimar)
16 de diciembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de enero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
12 de enero de 2018
Última verificación
1 de enero de 2018
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 110.180/2013
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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