Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia
25 janvier 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
199
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Madrid, Espagne, 28006
- Centro de Prevención del Deterioro Cognitivo
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
60 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in general cognition
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 octobre 2013
Achèvement primaire (Réel)
1 mai 2015
Achèvement de l'étude (Réel)
1 mai 2015
Dates d'inscription aux études
Première soumission
22 décembre 2019
Première soumission répondant aux critères de contrôle qualité
25 janvier 2020
Première publication (Réel)
29 janvier 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 15/382-E_BS
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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