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Computerized Cognitive Training for the Elderly

12. januar 2018 oppdatert av: 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

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • RJ
      • Rio de Janeiro, RJ, Brasil, 21941590
        • Rekruttering
        • Federal University of Rio de Janeiro
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv 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
40 hours of a computerized cognitive training, given 1 hour daily
Andre navn:
  • kognitiv trening
  • opplæring
Aktiv 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
40 hours of a computerized cognitive training, given 1 hour daily
Andre navn:
  • kognitiv trening
  • opplæring
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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Global cognition score change
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Processing speed score change
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2014

Primær fullføring (Forventet)

1. desember 2018

Studiet fullført (Forventet)

1. desember 2019

Datoer for studieregistrering

Først innsendt

14. desember 2015

Først innsendt som oppfylte QC-kriteriene

15. desember 2015

Først lagt ut (Anslag)

16. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. januar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. januar 2018

Sist bekreftet

1. januar 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 110.180/2013

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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