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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Mild Cognitive Impairment, So Stated, Mild Dementia, Healthy

Intervention / Treatment
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* Other: LLM
* Other: FFA
* Other: Brain Fitness
* Other: VideoGrade


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LLM<br>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<br>* 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)<br>* Other names: PTC+CTC;|
| Experimental: PTC<br>Physical training only. Participants use the FitForAll exergaming computer platform as the physical training component (PTC). | Other: FFA<br>* PTC training Participants use the FitForAll exergaming computer platform as the physical training component (PTC)<br>|
| Experimental: CTC<br>Cognitive training only. Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC) | Other: Brain Fitness<br>* CTC training Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)<br>|
| No Intervention: Passive<br>Passive Control Participants do not receive an intervention serving as passive controls | |
| Active Comparator: Active<br>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<br>* Active cognitive training by use of the VideoGrade software by AUTH.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 Monhths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical fitness | Physical capacity was measured by means of the Senior Fitness Test | 2 months / 6+2 months / 12+2 months | 
| Episodic memory | calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome) | 2 months / 6+2 months / 12+2 months | 
| working memory | calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome) | 2 months / 6+2 months / 12+2 months | 
| executive function | calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome) | 2 months / 6+2 months / 12+2 months | 
| Quality of Life | WHOQoL | 2 months / 6+2 months / 12+2 months | 
| Instrumental Activities of daily living | IADL | 2 months / 6+2 months / 12+2 months | 
| Depressive symptoms | GDS | 2 months / 6+2 months / 12+2 months | 
| 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 | 2 months |