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

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ClinicalTrials.gov Identifier: NCT02313935
Recruitment Status : Completed
First Posted : December 10, 2014
Last Update Posted : December 11, 2014
Sponsor:
Collaborator:
Greek Alzheimer's Association and Related Disorders
Information provided by (Responsible Party):
Panos Bamidis, Aristotle University Of Thessaloniki

Tracking Information
First Submitted Date  ICMJE December 8, 2014
First Posted Date  ICMJE December 10, 2014
Last Update Posted Date December 11, 2014
Study Start Date  ICMJE November 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
overall cognition [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
  • physical fitness [ Time Frame: 2 months / 6+2 months / 12+2 months ]
    Physical capacity was measured by means of the Senior Fitness Test
  • Episodic memory [ Time Frame: 2 months / 6+2 months / 12+2 months ]
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
  • working memory [ Time Frame: 2 months / 6+2 months / 12+2 months ]
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
  • executive function [ Time Frame: 2 months / 6+2 months / 12+2 months ]
    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
  • Quality of Life [ Time Frame: 2 months / 6+2 months / 12+2 months ]
    WHOQoL
  • Instrumental Activities of daily living [ Time Frame: 2 months / 6+2 months / 12+2 months ]
    IADL
  • Depressive symptoms [ Time Frame: 2 months / 6+2 months / 12+2 months ]
    GDS
  • Brain function [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive/Physical Computer-Game Blended Training of Elderly: Neuroscientific LLM Studies
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Mild Cognitive Impairment, So Stated
  • Mild Dementia
  • Healthy
Intervention  ICMJE
  • 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 Name: PTC+CTC
  • Other: FFA
    PTC training Participants use the FitForAll exergaming computer platform as the physical training component (PTC)
  • Other: Brain Fitness
    CTC training Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
  • Other: VideoGrade
    Active cognitive training by use of the VideoGrade software by AUTH.
Study Arms  ICMJE
  • 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)
    Intervention: Other: LLM
  • Experimental: PTC
    Physical training only. Participants use the FitForAll exergaming computer platform as the physical training component (PTC).
    Intervention: Other: FFA
  • Experimental: CTC
    Cognitive training only. Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
    Intervention: Other: Brain Fitness
  • 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.
    Intervention: Other: VideoGrade
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2014)
581
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02313935
Other Study ID Numbers  ICMJE 84171-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Panos Bamidis, Aristotle University Of Thessaloniki
Study Sponsor  ICMJE Aristotle University Of Thessaloniki
Collaborators  ICMJE Greek Alzheimer's Association and Related Disorders
Investigators  ICMJE Not Provided
PRS Account Aristotle University Of Thessaloniki
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP