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Completed

NCT Number: NCT02313935

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

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.

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Key information

Conditions

Mild Cognitive Impairment, So Stated Cognition Disorders Cognitive Dysfunction Healthy Mental Disorders Mild Dementia Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LLM

Other

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

FFA

Other

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

Brain Fitness

Other

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

VideoGrade

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. physical fitness

    Time frame: 2 months / 6+2 months / 12+2 months

    Physical capacity was measured by means of the Senior Fitness Test

  2. 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)

  3. 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)

  4. 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)

  5. Quality of Life

    Time frame: 2 months / 6+2 months / 12+2 months

    WHOQoL

  6. Instrumental Activities of daily living

    Time frame: 2 months / 6+2 months / 12+2 months

    IADL

  7. Depressive symptoms

    Time frame: 2 months / 6+2 months / 12+2 months

    GDS

  8. 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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Greek Alzheimer's Association and Related Disorders

Registry information

Official study 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

Acronym: LLM-AUTH

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Dec 10, 2014
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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