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Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The LLM Project (LLM)

Primary Purpose

Mild Cognitive Impairment, Mild Dementia, Healthy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LLM training
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 focused on measuring cognitive training, physical training, exercise games, novelty serious games, computer training, mild cognitive impairment, mild dementia, healthy elderly

Eligibility Criteria

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

Inclusion Criteria:

no severe cognitive impairment [Mini-Mental State Examination, MMSE ≥ 18], fluent language skills, agreement of a medical doctor and 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 Type

    Experimental

    No Intervention

    Arm Label

    LLM training

    Passive Control

    Arm Description

    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)

    Participants do not receive an intervention serving as passive controls

    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 (WHO Quality of Life)
    Instrumental Activities of daily living
    IADL
    Depressive symptoms
    GDS (Geriatric depression scale)
    Brain function
    changes in abnormal brain waves that correlate with mild cognitive decline and dementia as measured by EEG

    Full Information

    First Posted
    October 14, 2014
    Last Updated
    October 17, 2014
    Sponsor
    Aristotle University Of Thessaloniki
    Collaborators
    National and Kapodistrian University of Athens, University of Ulm, Greek Alzheimer's Association and Related Disorders
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02267499
    Brief Title
    Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The LLM Project
    Acronym
    LLM
    Official Title
    The Effects of Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The Long Lasting Memories Project (LLM)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    April 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
    National and Kapodistrian University of Athens, University of Ulm, 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 combined cognitive and physical exercise improves global cognition when compared to a control group; and that the number of sessions within exercising participants predict cognitive benefits. In addition, we explored the impact of potential moderators on combined exercise-induced cognitive benefits.
    Detailed Description
    The multicenter study 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 vs. passive control]. Post-test was conducted within 2 weeks after completion of the exercise period. Interventions were carried out in Athens and Thessaloniki (Greece) within day care centers, hospitals, senior care centers, a memory outpatient center, local parishes, at university campus facilities (university community installations), and at participants' homes. Institutions had to provide at least 5 exercise weeks, with a frequency of at least 1 physical and 2 cognitive exercise sessions per week, resulting in at least 5 physical and 10 cognitive exercise sessions in total.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment, Mild Dementia, Healthy
    Keywords
    cognitive training, physical training, exercise games, novelty serious games, computer training, mild cognitive impairment, mild dementia, healthy elderly

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    322 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LLM training
    Arm Type
    Experimental
    Arm Description
    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
    Passive Control
    Arm Type
    No Intervention
    Arm Description
    Participants do not receive an intervention serving as passive controls
    Intervention Type
    Other
    Intervention Name(s)
    LLM training
    Other Intervention Name(s)
    PTC+CTC
    Intervention Description
    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)
    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 months
    Secondary Outcome Measure Information:
    Title
    physical fitness
    Description
    Physical capacity was measured by means of the Senior Fitness Test
    Time Frame
    2 months
    Title
    Episodic memory
    Description
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
    Time Frame
    2 months
    Title
    working memory
    Description
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
    Time Frame
    2 months
    Title
    executive function
    Description
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
    Time Frame
    2 months
    Title
    Quality of Life
    Description
    WHOQoL (WHO Quality of Life)
    Time Frame
    2 months
    Title
    Instrumental Activities of daily living
    Description
    IADL
    Time Frame
    2 months
    Title
    Depressive symptoms
    Description
    GDS (Geriatric depression scale)
    Time Frame
    2 months
    Title
    Brain function
    Description
    changes in abnormal brain waves that correlate with mild cognitive decline and dementia as measured by EEG
    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 [Mini-Mental State Examination, MMSE ≥ 18], fluent language skills, agreement of a medical doctor and 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

    Links:
    URL
    http://www.longlastingmemories.eu
    Description
    The LLM project web site

    Learn more about this trial

    Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The LLM Project

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