Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia
25 januari 2020 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
199
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Madrid, Spanje, 28006
- Centro de Prevención del Deterioro Cognitivo
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
60 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in general cognition
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 oktober 2013
Primaire voltooiing (Werkelijk)
1 mei 2015
Studie voltooiing (Werkelijk)
1 mei 2015
Studieregistratiedata
Eerst ingediend
22 december 2019
Eerst ingediend dat voldeed aan de QC-criteria
25 januari 2020
Eerst geplaatst (Werkelijk)
29 januari 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 januari 2020
Laatste update ingediend die voldeed aan QC-criteria
25 januari 2020
Laatst geverifieerd
1 januari 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 15/382-E_BS
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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