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Completed

NCT Number: NCT02267499

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LLM training

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)

Other names: PTC+CTC

Primary outcomes

  1. overall cognition

    Time frame: 2 months

    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 outcomes

  1. physical fitness

    Time frame: 2 months

    Physical capacity was measured by means of the Senior Fitness Test

  2. Episodic memory

    Time frame: 2 months

    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)

  3. working memory

    Time frame: 2 months

    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)

  4. executive function

    Time frame: 2 months

    calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)

  5. Quality of Life

    Time frame: 2 months

    WHOQoL (WHO Quality of Life)

  6. Instrumental Activities of daily living

    Time frame: 2 months

    IADL

  7. Depressive symptoms

    Time frame: 2 months

    GDS (Geriatric depression scale)

  8. Brain function

    Time frame: 2 months

    changes in abnormal brain waves that correlate with mild cognitive decline and dementia as measured by EEG

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Greek Alzheimer's Association and Related Disorders
  • National and Kapodistrian University of Athens
  • University of Ulm

Registry information

Official study title

The Effects of Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The Long Lasting Memories Project (LLM)

Acronym: LLM

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Oct 17, 2014
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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