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

December 10, 2014 updated by: Panos Bamidis, Aristotle University Of Thessaloniki

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

581

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)
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 Names:
  • PTC+CTC
Experimental: PTC
Physical training only. Participants use the FitForAll exergaming computer platform as the physical training component (PTC).
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)
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.
Active cognitive training by use of the VideoGrade software by AUTH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 Monhths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical fitness
Time Frame: 2 months / 6+2 months / 12+2 months
Physical capacity was measured by means of the Senior Fitness Test
2 months / 6+2 months / 12+2 months
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)
2 months / 6+2 months / 12+2 months
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)
2 months / 6+2 months / 12+2 months
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)
2 months / 6+2 months / 12+2 months
Quality of Life
Time Frame: 2 months / 6+2 months / 12+2 months
WHOQoL
2 months / 6+2 months / 12+2 months
Instrumental Activities of daily living
Time Frame: 2 months / 6+2 months / 12+2 months
IADL
2 months / 6+2 months / 12+2 months
Depressive symptoms
Time Frame: 2 months / 6+2 months / 12+2 months
GDS
2 months / 6+2 months / 12+2 months
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
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 84171-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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