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临床试验/NCT02313935
NCT02313935已完成不适用

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

Aristotle University Of Thessaloniki0 个研究点目标入组 581 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
581
主要终点
overall cognition

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • no severe cognitive impairment [MMSE ≥ 18]
  • fluent language skills
  • agreement of a medical doctor
  • time commitment to the test and exercise protocol.

排除标准

  • 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.

结局指标

主要结局

overall cognition

时间窗: 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

次要结局

  • Depressive symptoms(2 months / 6+2 months / 12+2 months)
  • Instrumental Activities of daily living(2 months / 6+2 months / 12+2 months)
  • Brain function(2 months)
  • physical fitness(2 months / 6+2 months / 12+2 months)
  • Episodic memory(2 months / 6+2 months / 12+2 months)
  • working memory(2 months / 6+2 months / 12+2 months)
  • executive function(2 months / 6+2 months / 12+2 months)
  • Quality of Life(2 months / 6+2 months / 12+2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Panos Bamidis

Project Co-ordinator

Aristotle University Of Thessaloniki

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