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Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia

25. januar 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

199

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Madrid, Spanien, 28006
        • Centro de Prevención del Deterioro Cognitivo

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.).
Andet: Multifactorial Memory Training Program (UMAM method)
Ingen indgriben: 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.).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in general cognition
Tidsramme: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in verbal memory
Tidsramme: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in logical memory
Tidsramme: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in visual memory
Tidsramme: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in daily memory
Tidsramme: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in attentional amplitude
Tidsramme: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in attentional control
Tidsramme: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in attention and processing speed
Tidsramme: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in alternating attention and planning
Tidsramme: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in naming ability (language)
Tidsramme: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in verbal fluency (language)
Tidsramme: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in subjective memory
Tidsramme: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in mood
Tidsramme: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
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.
This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The Cognitive Reserve as a predictor of change.
Tidsramme: Cognitive Reserve was assessed in the pre-intervention assessment.
The Cognitive Reserve was assessed with Rami Test. The score ranges from 0 to 25 points.
Cognitive Reserve was assessed in the pre-intervention assessment.
The Genetic Profile as a predictor of change.
Tidsramme: The Genetic Profile was assessed in the pre-intervention assessment.
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).
The Genetic Profile was assessed in the pre-intervention assessment.
The Brain Volume as a predictor of change.
Tidsramme: The Brain Volume was assessed in the pre-intervention assessment.
The Brain Volume (total gray volume, left hippocampus, right hippocampus and total intracranial volume) was assessed by magnetic resonance imaging. Unit of measure: mm3.
The Brain Volume was assessed in the pre-intervention assessment.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Madrid Salud

Samarbejdspartnere

Universidad Complutense de Madrid
Hospital San Carlos, Madrid
Centro de Tecnología Biomédica, Madrid

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2013

Primær færdiggørelse (Faktiske)

1. maj 2015

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

22. december 2019

Først indsendt, der opfyldte QC-kriterier

25. januar 2020

Først opslået (Faktiske)

29. januar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15/382-E_BS

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