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临床试验/NCT02632604
NCT02632604Unknown不适用

Computerized Cognitive Training for the Elderly

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Global cognition score change

研究概览

简要总结

The purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for the elderly

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age above 60 years old; Portuguese as main language (learned before 12 years of age); Mini Mental State Examination above 26 points;

排除标准

  • 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).

研究组 & 干预措施

Bottom-up to top-down cognitive training

Active Comparator

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

干预措施: Computerized cognitive training (Behavioral)

Top-down to bottom-up cognitive training

Active Comparator

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

干预措施: Computerized cognitive training (Behavioral)

Computer games

Placebo Comparator

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).

干预措施: Computer games (Behavioral)

结局指标

主要结局

Global cognition score change

时间窗: 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

次要结局

  • Functional status score change(through study completion, an average of 1 year)
  • Short-term memory score change(through study completion, an average of 1 year)
  • Praxis score change(through study completion, an average of 1 year)
  • Quality of life score change(through study completion, an average of 1 year)
  • Cognitive flexibility score change(through study completion, an average of 1 year)
  • Independence in activities of daily living score change(through study completion, an average of 1 year)
  • Concentration score change(through study completion, an average of 1 year)
  • working memory score change(through study completion, an average of 1 year)
  • Instrumental activity of daily living score change(through study completion, an average of 1 year)
  • Processing speed score change(through study completion, an average of 1 year)
  • learning score change(through study completion, an average of 1 year)
  • social cognition score change(through study completion, an average of 1 year)
  • Depression score change(through study completion, an average of 1 year)
  • Timed instrumental activities of daily living score change(through study completion, an average of 1 year)
  • Physical activity score change(through study completion, an average of 1 year)
  • Episodic memory score change(through study completion, an average of 1 year)
  • Attention score change(through study completion, an average of 1 year)
  • long-term memory score change(through study completion, an average of 1 year)
  • Semantic memory score change(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rogerio Panizzutti

Professor

Universidade Federal do Rio de Janeiro

研究点 (1)

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