Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia
2020年1月25日 更新者：Madrid Salud
Cognitive Training in Elders Without Dementia Using UMAM Method. Genetic, Brain Volume and Cognitive Reserve Predictors: A Randomized Controlled Study
The study is oriented to analyze the effectiveness of a cognitive training method (UMAM) on cognitive functions, subjective memory and mood state in elderly people without dementia.
On the other hand, the study aims to examine whether variables such as cognitive reserve (e.g.
educational level), APOE genotype and intracranial volume are related to increased benefit after the intervention.
The researchers hope to find that greater cognitive reserve, not having the APOE allele ε4, and a greater volume of memory-related brain areas, are associated with better outcomes after the cognitive intervention.
調査の概要
研究の種類
介入
入学 (実際)
199
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
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Madrid、スペイン、28006
- Centro de Prevención del Deterioro Cognitivo
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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:
- Being over 60 years old.
- Having a global cognitive performance > 23 in the Mini Mental State Examination Test.
- Having no history of neurological or serious psychiatric disorders (severe psycho-affective disorders and psychosis or other psychiatric disorders like alcoholism).
Exclusion Criteria:
- Chronic use of anxiolytics.
- Chronic use of neuroleptics.
- Chronic use of anticonvulsants.
- Having hearing or vision impairments that would preclude testing.
- Magnetic Resonance Imaging (MRI) contraindications.
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Experimental Group
The experimental group carried out a 30-session multi-factorial group memory training program (UMAM method), with a frequency of three weekly sessions of 90 minutes each. The training program consists of four modules: 1- Stimulation of cognitive processes; learning and practicing internal memory strategies and solving everyday forgetfulness; 2- Instruction in basic concepts about memory; 3- Intervention on daily living and forgetting experiences, using internal and external strategies to solve everyday memory failures; 4- Metacognition or metamemory: the subjects were to reflect about their cognitive failures by analyzing the causes and variables of those failures. In addition, the experimental group followed the standard activities in which all users attending the Center are involved (planned interviews, dialogue-conferences, general health recommendations, etc.). |
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介入なし：Control Group
The Control Group followed the standard activities in which all users attending the Center are involved (planned interviews, dialogue-conferences, general health recommendations, etc.).
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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 |
|---|---|---|
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Change in general cognition
時間枠：This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in general cognition, assessed with the Mini Mental State Examination Test (MMSE) and the 7 Minutes Test (7M).The score ranges from 0 to 30 points (MMSE) and from 0 to 89 points (7M).
In both cases, the higher scores indicate a better outcome.
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This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in verbal memory
時間枠：This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in verbal memory, assessed with the Word List Test of the Wechsler Memory Scale-III.
The score ranges from 0 to 48 points.
Higher scores indicate a better outcome.
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This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in logical memory
時間枠：This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in immediate and delayed logical memory, assessed with the Logical Memory Test (immediate and delayed units) of the Wechsler Memory Scale-III.
The score ranges from 0 to 75 points (immediate units) and from 0 to 50 (delayed units).
Higher scores indicate a better outcome.
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This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in visual memory
時間枠：This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in visual memory, assessed with the Rey memory test (form B).
The score ranges from 0 to 22 points.
Higher scores indicate a better outcome.
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This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in daily memory
時間枠：This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in daily memory, assessed with the Rivermead Behavioral Memory Test.
The score ranges from 0 to 24 points.
Higher scores indicate a better outcome.
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This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in attentional amplitude
時間枠：This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in attentional amplitude, assessed with the Direct Digit Test of the Wechsler Memory Scale-III.
The score ranges from 0 to 16 points.
Higher scores indicate a better outcome.
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This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in attentional control
時間枠：This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in attentional control, assessed with the Inverse Digit Test of the Wechsler Memory Scale-III.
The score ranges from 0 to 14 points.
Higher scores indicate a better outcome.
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This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in attention and processing speed
時間枠：This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in attention, assessed with the Trail Making Test, form A. The score ranges from 0 to 200 points.
Higher scores indicate a worse outcome.
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This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in alternating attention and planning
時間枠：This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in alternating attention and planning, assessed with the Trail Making Test, form B. The score ranges from 0 to 400 points.
Higher scores indicate a worse outcome.
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This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in naming ability (language)
時間枠：This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in naming ability, assessed with the Boston Naming Test.
The score ranges from 0 to 60 points.
Higher scores indicate a better outcome.
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This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in verbal fluency (language)
時間枠：This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in phonologic and semantic verbal fluency, assessed with the Phonological Verbal Fluency Test and the Semantic Fluency Test respectively.
The score goes from zero onwards (there is no upper limit).
Higher scores indicate a better outcome.
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This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in subjective memory
時間枠：This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in Subjective Memory, assessed with the Memory Failures of Everyday Questionnaire.The score ranges from 0 to 56 points.
Higher scores indicate a worse outcome.
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This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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Change in mood
時間枠：This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The measure of the post-intervention change in mood, assessed with the Geriatric Depression Scale.
The score ranges from 0 to 15 points.
Higher scores indicate a worse outcome.
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This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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The Cognitive Reserve as a predictor of change.
時間枠：Cognitive Reserve was assessed in the pre-intervention assessment.
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The Cognitive Reserve was assessed with Rami Test.
The score ranges from 0 to 25 points.
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Cognitive Reserve was assessed in the pre-intervention assessment.
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The Genetic Profile as a predictor of change.
時間枠：The Genetic Profile was assessed in the pre-intervention assessment.
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The Genetic Profile was obtained by genetic analysis employing a blood test.
APOE gene has been coded as 1 (meaning no ε4 allele), or 0 (for at least one ε4 allele).
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The Genetic Profile was assessed in the pre-intervention assessment.
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The Brain Volume as a predictor of change.
時間枠：The Brain Volume was assessed in the pre-intervention assessment.
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The Brain Volume (total gray volume, left hippocampus, right hippocampus and total intracranial volume) was assessed by magnetic resonance imaging.
Unit of measure: mm3.
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The Brain Volume was assessed in the pre-intervention assessment.
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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。
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 (実際)
2013年10月1日
一次修了 (実際)
2015年5月1日
研究の完了 (実際)
2015年5月1日
試験登録日
最初に提出
2019年12月22日
QC基準を満たした最初の提出物
2020年1月25日
最初の投稿 (実際)
2020年1月29日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月29日
QC基準を満たした最後の更新が送信されました
2020年1月25日
最終確認日
2020年1月1日
詳しくは
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。