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Computerized Cognitive Training for the Elderly

12. ledna 2018 aktualizováno: Rogerio Panizzutti, Universidade Federal do Rio de Janeiro
The purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for the elderly

Přehled studie

Postavení

Neznámý

Podmínky

Intervence / Léčba

Detailní popis

Cognitive impairments are prominent features of aging and are mostly characterized by memory difficulties. Neuroplasticity based computerized cognitive trainings have been emerging for the last two decades and are an attempt to help the elderly population with their impairments.

The aim of this study is to perform a computerized cognitive training to improve attention, concentration, learning, and quality of life in elderly participants. The investigators are interested in testing the differential efficacy between a bottom-up to top-down versus a top-down to bottom-up computerized cognitive training.

The investigators will conduct a 40 hours computerized, adaptable, cognitive training program in participants 60 years of age and above. Participants will come for 1 hour, daily, and perform a bottom-up to top-down or top-down to bottom-up training, or control games for about 2 months. Bottom-up to top-down and top-down to bottom-up exercises are chosen to target cognitive domains such as divided and selective attention, short-term and working memory, orientation skills and social cognition. Cognitive and emotional data will be collected before the training, half way through, and after the training, to assess progress in several aspects of their functioning.

The investigators hypothesize bottom-up to top-down and top-down to bottom-up trainings will be effective as compared to the control games. They also expect that bottom-up to top-down training to be more efficient compared to top-down to bottom-up training because the first targets more basic cognitive functions which then allows triggering higher cognitive functions, reaching optimal cognitive performance levels more rapidly, where as the second may start with a too high demand on cognitive functions, which may compromise participants ability to reach optimal levels of cognitive performance as fast as the first type of training, if they do not have the "bottom-up lever" first. The investigators also hypothesize that both trainings will improve quality of life.

Typ studie

Intervenční

Zápis (Očekávaný)

150

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Brazílie
    • RJ
      • Rio de Janeiro, RJ, Brazílie, 21941590
        • Nábor
        • Federal University of Rio de Janeiro
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

60 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • age above 60 years old; Portuguese as main language (learned before 12 years of age); Mini Mental State Examination above 26 points;

Exclusion Criteria:

  • Intellectual Quotient below 70; serious medical or neurological condition preventing from participation in the study; substance abuse (according to Diagnostic and Statistical Manual of mental disorders-IV criteria).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Bottom-up to top-down cognitive training
Participants are given 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes
Behaviorální: Computerized cognitive training
40 hours of a computerized cognitive training, given 1 hour daily
Ostatní jména:
  • kognitivní trénink
  • výcvik
Aktivní komparátor: Top-down to bottom-up cognitive training
Participants are given 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes
Behaviorální: Computerized cognitive training
40 hours of a computerized cognitive training, given 1 hour daily
Ostatní jména:
  • kognitivní trénink
  • výcvik
Komparátor placeba: Computer games
Participants are given 40 hours of computer games commonly found on the internet and which do not involve a high demand in cognitive functions (e.g. fishing game, pinball game, tetris, etc).
Behaviorální: Computer games

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Global cognition score change
Časové okno: through study completion, an average of 1 year
An average of all the cognitive measures will be done to calculate the global cognition score and change will be made between endpoint and midpoint and midpoint and baseline
through study completion, an average of 1 year

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Processing speed score change
Časové okno: through study completion, an average of 1 year
Processing speed score will be measured using the identification task from Cogstate tests battery
through study completion, an average of 1 year
Attention score change
Časové okno: through study completion, an average of 1 year
Attention score will be measured using the detection task from Cogstate tests battery
through study completion, an average of 1 year
Concentration score change
Časové okno: through study completion, an average of 1 year
Concentration score will be measured using the Trail Making Test
through study completion, an average of 1 year
Short-term memory score change
Časové okno: through study completion, an average of 1 year
Short- term memory score will be measured using the Rey Auditory-Verbal learning test
through study completion, an average of 1 year
long-term memory score change
Časové okno: through study completion, an average of 1 year
long- term memory score will be measured using the Rey Auditory-Verbal learning test
through study completion, an average of 1 year
learning score change
Časové okno: through study completion, an average of 1 year
learning score will be measured using the Rey Auditory-Verbal learning test
through study completion, an average of 1 year
working memory score change
Časové okno: through study completion, an average of 1 year
working memory score will be measured using the 1-back and 2-back tasks from the Cogstate tests battery
through study completion, an average of 1 year
Semantic memory score change
Časové okno: through study completion, an average of 1 year
semantic memory score will be measured using the Verbal fluency test
through study completion, an average of 1 year
Cognitive flexibility score change
Časové okno: through study completion, an average of 1 year
Cognitive flexibility score will be measured using the Set shifting task from the Cogstate tests battery
through study completion, an average of 1 year
social cognition score change
Časové okno: through study completion, an average of 1 year
Social cognition score will be measured using the Social-Emotional Cognition task from the Cogstate tests battery
through study completion, an average of 1 year
Depression score change
Časové okno: through study completion, an average of 1 year
Depression score will be measured using the Geriatric Depression Scale
through study completion, an average of 1 year
Instrumental activity of daily living score change
Časové okno: through study completion, an average of 1 year
Instrumental activity of daily living score will be measured using the Lawton instrumental activity of daily living scale
through study completion, an average of 1 year
Independence in activities of daily living score change
Časové okno: through study completion, an average of 1 year
Independence in activities of daily living score will be measured using the Katz Independence in activities of daily living scale
through study completion, an average of 1 year
Functional status score change
Časové okno: through study completion, an average of 1 year
Functional status score will be measured using the Direct Assessment of Functional Status questionnaire
through study completion, an average of 1 year
Timed instrumental activities of daily living score change
Časové okno: through study completion, an average of 1 year
Timed instrumental activities of daily living score will be measured using the Timed instrumental activities of daily living scale
through study completion, an average of 1 year
Physical activity score change
Časové okno: through study completion, an average of 1 year
Physical activity score will be measured using the International Physical Activity Questionnaire
through study completion, an average of 1 year
Praxis score change
Časové okno: through study completion, an average of 1 year
Praxis score will be measured using the Cambridge Cognition Examination test
through study completion, an average of 1 year
Episodic memory score change
Časové okno: through study completion, an average of 1 year
Episodic memory score will be measured using the Cambridge Cognition Examination test
through study completion, an average of 1 year
Quality of life score change
Časové okno: through study completion, an average of 1 year
Quality of life will be assessed with the World Health Organization Quality of Life questionnaire
through study completion, an average of 1 year

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Universidade Federal do Rio de Janeiro

Vyšetřovatelé

  • Vrchní vyšetřovatel: Rogério Panizzutti, M.D, PhD, Universidade Federal do Rio de Janeiro

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. ledna 2014

Primární dokončení (Očekávaný)

1. prosince 2018

Dokončení studie (Očekávaný)

1. prosince 2019

Termíny zápisu do studia

První předloženo

14. prosince 2015

První předloženo, které splnilo kritéria kontroly kvality

15. prosince 2015

První zveřejněno (Odhad)

16. prosince 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. ledna 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. ledna 2018

Naposledy ověřeno

1. ledna 2018

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 110.180/2013

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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