- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT04245579
Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia
Cognitive Training in Elders Without Dementia Using UMAM Method. Genetic, Brain Volume and Cognitive Reserve Predictors: A Randomized Controlled Study
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Madrid, Spanyolország, 28006
- Centro de Prevención del Deterioro Cognitivo
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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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Nincs beavatkozás: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Change in general cognition
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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.
Időkeret: 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.
Időkeret: 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.
Időkeret: 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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Együttműködők és nyomozók
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 15/382-E_BS
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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