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Cognitive/Physical Computer-Game Blended Training of Elderly: Neuroscientific LLM Studies (LLM-AUTH)

Primary Purpose

Mild Cognitive Impairment, So Stated, Mild Dementia, Healthy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LLM
FFA
Brain Fitness
VideoGrade
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment, So Stated

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • no severe cognitive impairment [MMSE ≥ 18]
  • fluent language skills
  • agreement of a medical doctor
  • time commitment to the test and exercise protocol.

Exclusion Criteria:

  • concurrent participation in another study
  • severe physical or psychological disorders which precluded participation in the intervention (i.e., inability to follow instructions)
  • unrecovered neurological disorders such as stroke, traumatic brain injury, unstable medication within the past three months
  • severe and uncorrectable vision problems, or hearing aid for less than three months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Active Comparator

    Arm Label

    LLM

    PTC

    CTC

    Passive

    Active

    Arm Description

    LLM training Participants use the FitForAll exergaming computer platform as the physical training component (PTC); Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)

    Physical training only. Participants use the FitForAll exergaming computer platform as the physical training component (PTC).

    Cognitive training only. Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)

    Passive Control Participants do not receive an intervention serving as passive controls

    Active Control Participants receive an alternative cognitive training scheme; software was built on purpose by the AUTH team. The software is called VideoGrade and uses YouTube documentaries.

    Outcomes

    Primary Outcome Measures

    overall cognition
    Greek versions of the California Verbal Learning Test [CVLT], the Digit Span Test and the Trail Making Test [TMT] were used to assess cognitive outcomes

    Secondary Outcome Measures

    physical fitness
    Physical capacity was measured by means of the Senior Fitness Test
    Episodic memory
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
    working memory
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
    executive function
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
    Quality of Life
    WHOQoL
    Instrumental Activities of daily living
    IADL
    Depressive symptoms
    GDS
    Brain function
    changes in abnormal brain waves that correlate with mild cognitive decline and dementia as measured by EEG and/or ERPs; changes in resting state networks; localisation of brain region activations/de-activations

    Full Information

    First Posted
    December 8, 2014
    Last Updated
    December 10, 2014
    Sponsor
    Aristotle University Of Thessaloniki
    Collaborators
    Greek Alzheimer's Association and Related Disorders
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02313935
    Brief Title
    Cognitive/Physical Computer-Game Blended Training of Elderly: Neuroscientific LLM Studies
    Acronym
    LLM-AUTH
    Official Title
    Effects of Cognitive and/or Physical Exercises Blended by Computer Games in Elderly: The LLM Project Neuroscientific Investigations in Thessaloniki, Greece by the LLM Team at the Aristotle University of Thessaloniki
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aristotle University Of Thessaloniki
    Collaborators
    Greek Alzheimer's Association and Related Disorders

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study involved Information and Communication Technologies (ICT) and more specifically computer exercises blended with game activities. It was hypothesized that ICT facilitated, game blended cognitive and/or physical exercise improves global cognition when compared to control groups; moreover, these improvements may be manifested by brain activity changes; we explored the impact of potential moderators on combined exercise-induced cognitive benefits, as well as, individual/separate training schemes.
    Detailed Description
    The study was conducted in the Thessaloniki (Greece), in various centers. It was part of the Long Lasting Memories (LLM) project (www.longlastingmemories.eu), which was funded by the European Commission (Information and Communication Technologies Policy Support Program (ICT-PSP) for a three year period (2009-2012). It used a pre-post-test design with the between-participant factor group [intervention(s) vs. passive and/or active control]. Post-test was conducted within 2 weeks after completion of the exercise period. Interventions were carried out in Thessaloniki (Greece) within day care centers, hospitals, senior care centers, a memory outpatient center, local parishes, and at participants' homes. Centers had to provide 8 exercise weeks, with a frequency of at least 2 physical and 3 cognitive exercise sessions per week, resulting in at least 16 physical and 24 cognitive exercise sessions in total. A similar trial was registered with Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02267499

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment, So Stated, Mild Dementia, Healthy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    581 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LLM
    Arm Type
    Experimental
    Arm Description
    LLM training Participants use the FitForAll exergaming computer platform as the physical training component (PTC); Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
    Arm Title
    PTC
    Arm Type
    Experimental
    Arm Description
    Physical training only. Participants use the FitForAll exergaming computer platform as the physical training component (PTC).
    Arm Title
    CTC
    Arm Type
    Experimental
    Arm Description
    Cognitive training only. Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
    Arm Title
    Passive
    Arm Type
    No Intervention
    Arm Description
    Passive Control Participants do not receive an intervention serving as passive controls
    Arm Title
    Active
    Arm Type
    Active Comparator
    Arm Description
    Active Control Participants receive an alternative cognitive training scheme; software was built on purpose by the AUTH team. The software is called VideoGrade and uses YouTube documentaries.
    Intervention Type
    Other
    Intervention Name(s)
    LLM
    Other Intervention Name(s)
    PTC+CTC
    Intervention Description
    LLM training Participants use the FitForAll exergaming computer platform as the physical training component (PTC); Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
    Intervention Type
    Other
    Intervention Name(s)
    FFA
    Intervention Description
    PTC training Participants use the FitForAll exergaming computer platform as the physical training component (PTC)
    Intervention Type
    Other
    Intervention Name(s)
    Brain Fitness
    Intervention Description
    CTC training Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
    Intervention Type
    Other
    Intervention Name(s)
    VideoGrade
    Intervention Description
    Active cognitive training by use of the VideoGrade software by AUTH.
    Primary Outcome Measure Information:
    Title
    overall cognition
    Description
    Greek versions of the California Verbal Learning Test [CVLT], the Digit Span Test and the Trail Making Test [TMT] were used to assess cognitive outcomes
    Time Frame
    2 Monhths
    Secondary Outcome Measure Information:
    Title
    physical fitness
    Description
    Physical capacity was measured by means of the Senior Fitness Test
    Time Frame
    2 months / 6+2 months / 12+2 months
    Title
    Episodic memory
    Description
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
    Time Frame
    2 months / 6+2 months / 12+2 months
    Title
    working memory
    Description
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
    Time Frame
    2 months / 6+2 months / 12+2 months
    Title
    executive function
    Description
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
    Time Frame
    2 months / 6+2 months / 12+2 months
    Title
    Quality of Life
    Description
    WHOQoL
    Time Frame
    2 months / 6+2 months / 12+2 months
    Title
    Instrumental Activities of daily living
    Description
    IADL
    Time Frame
    2 months / 6+2 months / 12+2 months
    Title
    Depressive symptoms
    Description
    GDS
    Time Frame
    2 months / 6+2 months / 12+2 months
    Title
    Brain function
    Description
    changes in abnormal brain waves that correlate with mild cognitive decline and dementia as measured by EEG and/or ERPs; changes in resting state networks; localisation of brain region activations/de-activations
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: no severe cognitive impairment [MMSE ≥ 18] fluent language skills agreement of a medical doctor time commitment to the test and exercise protocol. Exclusion Criteria: concurrent participation in another study severe physical or psychological disorders which precluded participation in the intervention (i.e., inability to follow instructions) unrecovered neurological disorders such as stroke, traumatic brain injury, unstable medication within the past three months severe and uncorrectable vision problems, or hearing aid for less than three months.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24705268
    Citation
    Bamidis PD, Vivas AB, Styliadis C, Frantzidis C, Klados M, Schlee W, Siountas A, Papageorgiou SG. A review of physical and cognitive interventions in aging. Neurosci Biobehav Rev. 2014 Jul;44:206-20. doi: 10.1016/j.neubiorev.2014.03.019. Epub 2014 Apr 4.
    Results Reference
    background
    PubMed Identifier
    23912068
    Citation
    Ladas A, Frantzidis C, Bamidis P, Vivas AB. Eye Blink Rate as a biological marker of Mild Cognitive Impairment. Int J Psychophysiol. 2014 Jul;93(1):12-6. doi: 10.1016/j.ijpsycho.2013.07.010. Epub 2013 Aug 1.
    Results Reference
    background
    PubMed Identifier
    25206333
    Citation
    Frantzidis CA, Vivas AB, Tsolaki A, Klados MA, Tsolaki M, Bamidis PD. Functional disorganization of small-world brain networks in mild Alzheimer's Disease and amnestic Mild Cognitive Impairment: an EEG study using Relative Wavelet Entropy (RWE). Front Aging Neurosci. 2014 Aug 26;6:224. doi: 10.3389/fnagi.2014.00224. eCollection 2014.
    Results Reference
    result
    PubMed Identifier
    24472698
    Citation
    Frantzidis CA, Ladas AK, Vivas AB, Tsolaki M, Bamidis PD. Cognitive and physical training for the elderly: evaluating outcome efficacy by means of neurophysiological synchronization. Int J Psychophysiol. 2014 Jul;93(1):1-11. doi: 10.1016/j.ijpsycho.2014.01.007. Epub 2014 Jan 25.
    Results Reference
    result
    PubMed Identifier
    26973445
    Citation
    Klados MA, Styliadis C, Frantzidis CA, Paraskevopoulos E, Bamidis PD. Beta-Band Functional Connectivity is Reorganized in Mild Cognitive Impairment after Combined Computerized Physical and Cognitive Training. Front Neurosci. 2016 Feb 29;10:55. doi: 10.3389/fnins.2016.00055. eCollection 2016.
    Results Reference
    derived
    PubMed Identifier
    25945260
    Citation
    Styliadis C, Kartsidis P, Paraskevopoulos E, Ioannides AA, Bamidis PD. Neuroplastic effects of combined computerized physical and cognitive training in elderly individuals at risk for dementia: an eLORETA controlled study on resting states. Neural Plast. 2015;2015:172192. doi: 10.1155/2015/172192. Epub 2015 Apr 7.
    Results Reference
    derived
    Links:
    URL
    http://www.longlastingmemories.eu/
    Description
    The LLM project web site

    Learn more about this trial

    Cognitive/Physical Computer-Game Blended Training of Elderly: Neuroscientific LLM Studies

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