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

NCT ID: NCT02313935

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

581 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-04-30

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

Conditions

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Mild Cognitive Impairment, So Stated Mild Dementia Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type EXPERIMENTAL

LLM

Intervention Type 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)

PTC

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

Group Type EXPERIMENTAL

FFA

Intervention Type OTHER

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

CTC

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

Group Type EXPERIMENTAL

Brain Fitness

Intervention Type OTHER

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

Passive

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

VideoGrade

Intervention Type OTHER

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

Interventions

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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 Type OTHER

FFA

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

Intervention Type OTHER

Brain Fitness

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

Intervention Type OTHER

VideoGrade

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

Intervention Type OTHER

Other Intervention Names

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PTC+CTC

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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Greek Alzheimer's Association and Related Disorders

OTHER

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Panos Bamidis

Project Co-ordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Bamidis PD, Vivas AB, Styliadis C, Frantzidis C, Klados M, Schlee W, Siountas A, Papageorgiou SG. A review of physical and cognitive interventions in aging. Neurosci Biobehav Rev. 2014 Jul;44:206-20. doi: 10.1016/j.neubiorev.2014.03.019. Epub 2014 Apr 4.

Reference Type BACKGROUND
PMID: 24705268 (View on PubMed)

Ladas A, Frantzidis C, Bamidis P, Vivas AB. Eye Blink Rate as a biological marker of Mild Cognitive Impairment. Int J Psychophysiol. 2014 Jul;93(1):12-6. doi: 10.1016/j.ijpsycho.2013.07.010. Epub 2013 Aug 1.

Reference Type BACKGROUND
PMID: 23912068 (View on PubMed)

Frantzidis CA, Vivas AB, Tsolaki A, Klados MA, Tsolaki M, Bamidis PD. Functional disorganization of small-world brain networks in mild Alzheimer's Disease and amnestic Mild Cognitive Impairment: an EEG study using Relative Wavelet Entropy (RWE). Front Aging Neurosci. 2014 Aug 26;6:224. doi: 10.3389/fnagi.2014.00224. eCollection 2014.

Reference Type RESULT
PMID: 25206333 (View on PubMed)

Frantzidis CA, Ladas AK, Vivas AB, Tsolaki M, Bamidis PD. Cognitive and physical training for the elderly: evaluating outcome efficacy by means of neurophysiological synchronization. Int J Psychophysiol. 2014 Jul;93(1):1-11. doi: 10.1016/j.ijpsycho.2014.01.007. Epub 2014 Jan 25.

Reference Type RESULT
PMID: 24472698 (View on PubMed)

Klados MA, Styliadis C, Frantzidis CA, Paraskevopoulos E, Bamidis PD. Beta-Band Functional Connectivity is Reorganized in Mild Cognitive Impairment after Combined Computerized Physical and Cognitive Training. Front Neurosci. 2016 Feb 29;10:55. doi: 10.3389/fnins.2016.00055. eCollection 2016.

Reference Type DERIVED
PMID: 26973445 (View on PubMed)

Styliadis C, Kartsidis P, Paraskevopoulos E, Ioannides AA, Bamidis PD. Neuroplastic effects of combined computerized physical and cognitive training in elderly individuals at risk for dementia: an eLORETA controlled study on resting states. Neural Plast. 2015;2015:172192. doi: 10.1155/2015/172192. Epub 2015 Apr 7.

Reference Type DERIVED
PMID: 25945260 (View on PubMed)

Related Links

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http://www.llmcare.gr

The Greek LLM continuation project/business activity

Other Identifiers

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84171-A

Identifier Type: -

Identifier Source: org_study_id