Clinical trial NCT02267499: Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The LLM Project
Official title: The Effects of Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The Long Lasting Memories Project (LLM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Mild Dementia
Healthy
Keywords: cognitive training
physical training
exercise games
novelty serious games
computer training
mild cognitive impairment
mild dementia
healthy elderly
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: University of Ulm
name: Greek Alzheimer's Association and Related Disorders
First posted: 2014-10-17
Enrollment: 322
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall cognition
timeFrame: 2 months
Secondary outcomes:
measure: physical fitness
timeFrame: 2 months
measure: Episodic memory
timeFrame: 2 months
measure: working memory
timeFrame: 2 months
measure: executive function
timeFrame: 2 months
measure: Quality of Life
timeFrame: 2 months
measure: Instrumental Activities of daily living
timeFrame: 2 months
measure: Depressive symptoms
timeFrame: 2 months
measure: Brain function
timeFrame: 2 months
Other outcomes:
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