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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

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
Mild Cognitive Impairment, So Stated Mild Dementia Healthy Other: LLM Other: FFA Other: Brain Fitness Other: VideoGrade Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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 : November 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : April 2013

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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Panos Bamidis, Project Co-ordinator, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02313935    
Other Study ID Numbers: 84171-A
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders
Cognition Disorders