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Computerized Cognitive Training for the Elderly

2018年1月12日 更新者: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

研究概览

详细说明

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.

研究类型

介入性

注册 (预期的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • RJ
      • Rio de Janeiro、RJ、巴西、21941590
        • 招聘中
        • Federal University of Rio de Janeiro
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器: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
40 hours of a computerized cognitive training, given 1 hour daily
其他名称:
  • 认知训练
  • 训练
有源比较器: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
40 hours of a computerized cognitive training, given 1 hour daily
其他名称:
  • 认知训练
  • 训练
安慰剂比较: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).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Global cognition score change
大体时间:through study completion, an average of 1 year
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
through study completion, an average of 1 year

次要结果测量

结果测量
措施说明
大体时间
Processing speed score change
大体时间:through study completion, an average of 1 year
Processing speed score will be measured using the identification task from Cogstate tests battery
through study completion, an average of 1 year
Attention score change
大体时间:through study completion, an average of 1 year
Attention score will be measured using the detection task from Cogstate tests battery
through study completion, an average of 1 year
Concentration score change
大体时间:through study completion, an average of 1 year
Concentration score will be measured using the Trail Making Test
through study completion, an average of 1 year
Short-term memory score change
大体时间:through study completion, an average of 1 year
Short- term memory score will be measured using the Rey Auditory-Verbal learning test
through study completion, an average of 1 year
long-term memory score change
大体时间:through study completion, an average of 1 year
long- term memory score will be measured using the Rey Auditory-Verbal learning test
through study completion, an average of 1 year
learning score change
大体时间:through study completion, an average of 1 year
learning score will be measured using the Rey Auditory-Verbal learning test
through study completion, an average of 1 year
working memory score change
大体时间:through study completion, an average of 1 year
working memory score will be measured using the 1-back and 2-back tasks from the Cogstate tests battery
through study completion, an average of 1 year
Semantic memory score change
大体时间:through study completion, an average of 1 year
semantic memory score will be measured using the Verbal fluency test
through study completion, an average of 1 year
Cognitive flexibility score change
大体时间:through study completion, an average of 1 year
Cognitive flexibility score will be measured using the Set shifting task from the Cogstate tests battery
through study completion, an average of 1 year
social cognition score change
大体时间:through study completion, an average of 1 year
Social cognition score will be measured using the Social-Emotional Cognition task from the Cogstate tests battery
through study completion, an average of 1 year
Depression score change
大体时间:through study completion, an average of 1 year
Depression score will be measured using the Geriatric Depression Scale
through study completion, an average of 1 year
Instrumental activity of daily living score change
大体时间:through study completion, an average of 1 year
Instrumental activity of daily living score will be measured using the Lawton instrumental activity of daily living scale
through study completion, an average of 1 year
Independence in activities of daily living score change
大体时间:through study completion, an average of 1 year
Independence in activities of daily living score will be measured using the Katz Independence in activities of daily living scale
through study completion, an average of 1 year
Functional status score change
大体时间:through study completion, an average of 1 year
Functional status score will be measured using the Direct Assessment of Functional Status questionnaire
through study completion, an average of 1 year
Timed instrumental activities of daily living score change
大体时间:through study completion, an average of 1 year
Timed instrumental activities of daily living score will be measured using the Timed instrumental activities of daily living scale
through study completion, an average of 1 year
Physical activity score change
大体时间:through study completion, an average of 1 year
Physical activity score will be measured using the International Physical Activity Questionnaire
through study completion, an average of 1 year
Praxis score change
大体时间:through study completion, an average of 1 year
Praxis score will be measured using the Cambridge Cognition Examination test
through study completion, an average of 1 year
Episodic memory score change
大体时间:through study completion, an average of 1 year
Episodic memory score will be measured using the Cambridge Cognition Examination test
through study completion, an average of 1 year
Quality of life score change
大体时间:through study completion, an average of 1 year
Quality of life will be assessed with the World Health Organization Quality of Life questionnaire
through study completion, an average of 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Rogério Panizzutti, M.D, PhD、Universidade Federal do Rio de Janeiro

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年1月1日

初级完成 (预期的)

2018年12月1日

研究完成 (预期的)

2019年12月1日

研究注册日期

首次提交

2015年12月14日

首先提交符合 QC 标准的

2015年12月15日

首次发布 (估计)

2015年12月16日

研究记录更新

最后更新发布 (实际的)

2018年1月17日

上次提交的符合 QC 标准的更新

2018年1月12日

最后验证

2018年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • 110.180/2013

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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