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

Not Applicable

Completed

• Conditions: Healthy; Mild Cognitive Impairment, So Stated; Mild Dementia
• Interventions: Other: Brain Fitness; Other: FFA; Other: LLM; Other: VideoGrade

• Registration Number: NCT02313935
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2012-05
• Study Completion: 2013-04
• Status Verified: 2014-12
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-10
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 581

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTC	Brain Fitness	Cognitive training only. Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
PTC	FFA	Physical training only. Participants use the FitForAll exergaming computer platform as the physical training component (PTC).
LLM	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)
Active	VideoGrade	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.

Primary Outcome Measures

Name	Time	Method
overall cognition	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

Name	Time	Method
Instrumental Activities of daily living	2 months / 6+2 months / 12+2 months	IADL
physical fitness	2 months / 6+2 months / 12+2 months	Physical capacity was measured by means of the Senior Fitness Test
Brain function	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
Episodic memory	2 months / 6+2 months / 12+2 months	calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
Depressive symptoms	2 months / 6+2 months / 12+2 months	GDS
working memory	2 months / 6+2 months / 12+2 months	calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
executive function	2 months / 6+2 months / 12+2 months	calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
Quality of Life	2 months / 6+2 months / 12+2 months	WHOQoL