NCT02313935

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
581

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

1.5 years

First QC Date

December 8, 2014

Last Update Submit

December 10, 2014

Conditions

Mild Cognitive Impairment, So StatedMild DementiaHealthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • physical fitness

    2 months / 6+2 months / 12+2 months

  • Episodic memory

    2 months / 6+2 months / 12+2 months

  • working memory

    2 months / 6+2 months / 12+2 months

  • executive function

    2 months / 6+2 months / 12+2 months

  • Quality of Life

    2 months / 6+2 months / 12+2 months

  • +3 more secondary outcomes

Study Arms (5)

LLM

EXPERIMENTAL

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

PTC

EXPERIMENTAL

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

Other: FFA

CTC

EXPERIMENTAL

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

Other: Brain Fitness

Passive

NO INTERVENTION

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

Active

ACTIVE COMPARATOR

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

Interventions

LLMOTHER

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)

Also known as: PTC+CTC
LLM
FFAOTHER

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

PTC
Brain FitnessOTHER

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

CTC
VideoGradeOTHER

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

Active

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • no severe cognitive impairment \[MMSE ≥ 18\]
  • fluent language skills
  • agreement of a medical doctor
  • time commitment to the test and exercise protocol.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 24705268BACKGROUND

  • 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.

    PMID: 23912068BACKGROUND

  • 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.

    PMID: 25206333RESULT

  • 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.

    PMID: 24472698RESULT

  • 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.

    PMID: 26973445DERIVED

  • 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.

    PMID: 25945260DERIVED

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Co-ordinator

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 10, 2014

Study Start

November 1, 2010

Primary Completion

May 1, 2012

Study Completion

April 1, 2013

Last Updated

December 11, 2014

Record last verified: 2014-12