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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

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (予想される)

150

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • RJ
      • Rio de Janeiro、RJ、ブラジル、21941590
        • 募集
        • Federal University of Rio de Janeiro
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

60年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:トリプル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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
他の名前:
  • 認知トレーニング
  • トレーニング
アクティブコンパレータ: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
他の名前:
  • 認知トレーニング
  • トレーニング
プラセボコンパレーター: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).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Global cognition score change
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Processing speed score change
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Rogério Panizzutti, M.D, PhD、Universidade Federal do Rio de Janeiro

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年1月1日

一次修了 (予想される)

2018年12月1日

研究の完了 (予想される)

2019年12月1日

試験登録日

最初に提出

2015年12月14日

QC基準を満たした最初の提出物

2015年12月15日

最初の投稿 (見積もり)

2015年12月16日

学習記録の更新

投稿された最後の更新 (実際)

2018年1月17日

QC基準を満たした最後の更新が送信されました

2018年1月12日

最終確認日

2018年1月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 110.180/2013

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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