Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The LLM Project

NCT ID: NCT02267499

Last Updated: 2014-10-20

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

322 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 combined cognitive and physical exercise improves global cognition when compared to a control group; and that the number of sessions within exercising participants predict cognitive benefits. In addition, we explored the impact of potential moderators on combined exercise-induced cognitive benefits.

Detailed Description

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The multicenter study 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 \[intervention vs. passive control\]. Post-test was conducted within 2 weeks after completion of the exercise period. Interventions were carried out in Athens and Thessaloniki (Greece) within day care centers, hospitals, senior care centers, a memory outpatient center, local parishes, at university campus facilities (university community installations), and at participants' homes.

Institutions had to provide at least 5 exercise weeks, with a frequency of at least 1 physical and 2 cognitive exercise sessions per week, resulting in at least 5 physical and 10 cognitive exercise sessions in total.

Conditions

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Mild Cognitive Impairment Mild Dementia Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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 training

Intervention Type OTHER

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)

Passive Control

Participants do not receive an intervention serving as passive controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Other Intervention Names

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PTC+CTC

Eligibility Criteria

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Inclusion Criteria

no severe cognitive impairment \[Mini-Mental State Examination, MMSE ≥ 18\], fluent language skills, agreement of a medical doctor and 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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National and Kapodistrian University of Athens

OTHER

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role collaborator

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

Assist. Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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238904

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

84171

Identifier Type: -

Identifier Source: org_study_id

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