Computerized Cognitive Training for the Elderly

Sponsor
Universidade Federal do Rio de Janeiro (Other)
Overall Status
Unknown status
CT.gov ID
NCT02632604
Collaborator
(none)
150
1
3
71
2.1

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for the elderly

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Computerized cognitive training
  • Behavioral: Computer games
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Computerized Cognitive Training for the Elderly
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

Behavioral: Computerized cognitive training
40 hours of a computerized cognitive training, given 1 hour daily
Other Names:
  • cognitive training
  • training
  • Active Comparator: 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

    Behavioral: Computerized cognitive training
    40 hours of a computerized cognitive training, given 1 hour daily
    Other Names:
  • cognitive training
  • training
  • Placebo Comparator: 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).

    Behavioral: Computer games

    Outcome Measures

    Primary Outcome Measures

    1. Global cognition score change [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

    Secondary Outcome Measures

    1. Processing speed score change [through study completion, an average of 1 year]

      Processing speed score will be measured using the identification task from Cogstate tests battery

    2. Attention score change [through study completion, an average of 1 year]

      Attention score will be measured using the detection task from Cogstate tests battery

    3. Concentration score change [through study completion, an average of 1 year]

      Concentration score will be measured using the Trail Making Test

    4. Short-term memory score change [through study completion, an average of 1 year]

      Short- term memory score will be measured using the Rey Auditory-Verbal learning test

    5. long-term memory score change [through study completion, an average of 1 year]

      long- term memory score will be measured using the Rey Auditory-Verbal learning test

    6. learning score change [through study completion, an average of 1 year]

      learning score will be measured using the Rey Auditory-Verbal learning test

    7. working memory score change [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

    8. Semantic memory score change [through study completion, an average of 1 year]

      semantic memory score will be measured using the Verbal fluency test

    9. Cognitive flexibility score change [through study completion, an average of 1 year]

      Cognitive flexibility score will be measured using the Set shifting task from the Cogstate tests battery

    10. social cognition score change [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

    11. Depression score change [through study completion, an average of 1 year]

      Depression score will be measured using the Geriatric Depression Scale

    12. Instrumental activity of daily living score change [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

    13. Independence in activities of daily living score change [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

    14. Functional status score change [through study completion, an average of 1 year]

      Functional status score will be measured using the Direct Assessment of Functional Status questionnaire

    15. Timed instrumental activities of daily living score change [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

    16. Physical activity score change [through study completion, an average of 1 year]

      Physical activity score will be measured using the International Physical Activity Questionnaire

    17. Praxis score change [through study completion, an average of 1 year]

      Praxis score will be measured using the Cambridge Cognition Examination test

    18. Episodic memory score change [through study completion, an average of 1 year]

      Episodic memory score will be measured using the Cambridge Cognition Examination test

    19. Quality of life score change [through study completion, an average of 1 year]

      Quality of life will be assessed with the World Health Organization Quality of Life questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Federal University of Rio de Janeiro Rio de Janeiro RJ Brazil 21941590

    Sponsors and Collaborators

    • Universidade Federal do Rio de Janeiro

    Investigators

    • Principal Investigator: RogĂ©rio Panizzutti, M.D, PhD, Universidade Federal do Rio de Janeiro

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rogerio Panizzutti, Professor, Universidade Federal do Rio de Janeiro
    ClinicalTrials.gov Identifier:
    NCT02632604
    Other Study ID Numbers:
    • 110.180/2013
    First Posted:
    Dec 16, 2015
    Last Update Posted:
    Jan 17, 2018
    Last Verified:
    Jan 1, 2018

    Study Results

    No Results Posted as of Jan 17, 2018