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

Healthy Clinical Trial

— LLM-AUTH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313935
• Other study ID #: 84171-A
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: December 10, 2014
• Start date: November 2010
• Est. completion date: April 2013

Study information

• Verified date: December 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 581
• Est. completion date: April 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Healthy
• Mild Cognitive Impairment
• Mild Cognitive Impairment, So Stated
• Mild Dementia

Intervention

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)
• FFA
PTC training Participants use the FitForAll exergaming computer platform as the physical training component (PTC)
• Brain Fitness
CTC training Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
• VideoGrade
Active cognitive training by use of the VideoGrade software by AUTH.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Greek Association of Alzheimer's Disease and Related Disorders

References & Publications (4)

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. Review. — View Citation

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.2014.0 — View Citation

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 Agi — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	physical fitness	Physical capacity was measured by means of the Senior Fitness Test	2 months / 6+2 months / 12+2 months	No
Secondary	Episodic memory	calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)	2 months / 6+2 months / 12+2 months	No
Secondary	working memory	calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)	2 months / 6+2 months / 12+2 months	No
Secondary	executive function	calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)	2 months / 6+2 months / 12+2 months	No
Secondary	Quality of Life	WHOQoL	2 months / 6+2 months / 12+2 months	No
Secondary	Instrumental Activities of daily living	IADL	2 months / 6+2 months / 12+2 months	No
Secondary	Depressive symptoms	GDS	2 months / 6+2 months / 12+2 months	No
Secondary	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	No

External Links

•   The Greek LLM continuation project/business activity
•   The LLM project web site