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

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Completed
CT.gov ID
NCT02313935
Collaborator
Greek Alzheimer's Association and Related Disorders (Other)
581
5
29

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: LLM
  • Other: FFA
  • Other: Brain Fitness
  • Other: VideoGrade
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
581 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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 Start Date :
Nov 1, 2010
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: LLM

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)

Other: LLM
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)
Other Names:
  • PTC+CTC
  • Experimental: PTC

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

    Other: FFA
    PTC training Participants use the FitForAll exergaming computer platform as the physical training component (PTC)

    Experimental: CTC

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

    Other: Brain Fitness
    CTC training Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)

    No Intervention: Passive

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

    Active Comparator: Active

    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.

    Other: VideoGrade
    Active cognitive training by use of the VideoGrade software by AUTH.

    Outcome Measures

    Primary Outcome Measures

    1. overall cognition [2 Monhths]

      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

    1. physical fitness [2 months / 6+2 months / 12+2 months]

      Physical capacity was measured by means of the Senior Fitness Test

    2. Episodic memory [2 months / 6+2 months / 12+2 months]

      calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)

    3. working memory [2 months / 6+2 months / 12+2 months]

      calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)

    4. executive function [2 months / 6+2 months / 12+2 months]

      calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)

    5. Quality of Life [2 months / 6+2 months / 12+2 months]

      WHOQoL

    6. Instrumental Activities of daily living [2 months / 6+2 months / 12+2 months]

      IADL

    7. Depressive symptoms [2 months / 6+2 months / 12+2 months]

      GDS

    8. Brain function [2 months]

      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

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Aristotle University Of Thessaloniki
    • Greek Alzheimer's Association and Related Disorders

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Panos Bamidis, Project Co-ordinator, Aristotle University Of Thessaloniki
    ClinicalTrials.gov Identifier:
    NCT02313935
    Other Study ID Numbers:
    • 84171-A
    First Posted:
    Dec 10, 2014
    Last Update Posted:
    Dec 11, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 11, 2014