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Computerized Cognitive Training for the Elderly

12. Januar 2018 aktualisiert von: 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

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

150

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Brasilien
    • RJ
      • Rio de Janeiro, RJ, Brasilien, 21941590
        • Rekrutierung
        • Federal University of Rio de Janeiro
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

60 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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
Verhalten: Computerized cognitive training
40 hours of a computerized cognitive training, given 1 hour daily
Andere Namen:
  • kognitives Training
  • Ausbildung
Aktiver Komparator: 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
Verhalten: Computerized cognitive training
40 hours of a computerized cognitive training, given 1 hour daily
Andere Namen:
  • kognitives Training
  • Ausbildung
Placebo-Komparator: 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).
Verhalten: Computer games

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Global cognition score change
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Processing speed score change
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universidade Federal do Rio de Janeiro

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2014

Primärer Abschluss (Voraussichtlich)

1. Dezember 2018

Studienabschluss (Voraussichtlich)

1. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

14. Dezember 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Dezember 2015

Zuerst gepostet (Schätzen)

16. Dezember 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Januar 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Januar 2018

Zuletzt verifiziert

1. Januar 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 110.180/2013

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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