Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia
25 stycznia 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
199
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
-
Madrid, Hiszpania, 28006
- Centro de Prevención del Deterioro Cognitivo
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
60 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.). |
|
|
Brak interwencji: 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.).
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in general cognition
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 października 2013
Zakończenie podstawowe (Rzeczywisty)
1 maja 2015
Ukończenie studiów (Rzeczywisty)
1 maja 2015
Daty rejestracji na studia
Pierwszy przesłany
22 grudnia 2019
Pierwszy przesłany, który spełnia kryteria kontroli jakości
25 stycznia 2020
Pierwszy wysłany (Rzeczywisty)
29 stycznia 2020
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
29 stycznia 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
25 stycznia 2020
Ostatnia weryfikacja
1 stycznia 2020
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 15/382-E_BS
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Nie
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .