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临床试验/NCT04835909
NCT04835909Unknown不适用

Effectiveness on Cognition of a Cognitive Training Intervention Based on Modern Board and Card Games in Mild Cognitive Impairment Patients: a Randomized Controlled Trial

Brain In Game scientific-technical service4 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2021年2月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
112
试验地点
4
主要终点
Change in visuospatial short-term memory from baseline to post intervention

研究概览

简要总结

Nowadays, on geriatric centres, cognitive decline used to be prevented by pen and paper exercises (Calero García & Navarro Gonzalez, 2006). However, as Lampit et al. (2014) suggest, studies based on the efficacy and effectiveness of new cognitive-based interventions in order to improve these cognitive processes are fundamental (Lampit et al., 2014). Cognitive-based interventions are interventions that directly or indirectly try to improve cognitive processes (Chiu et al., 2017). Between the different kinds of cognitive-based interventions, cognitive training permits stablish randomized controlled trials. Cognitive training consists of repeating during a concrete time a standardized set of tasks in order to maintain or improve one or some cognitive processes. Meta-analysis studies have shown that computerized cognitive training can improve in a moderate size some cognitive processes in elderly people with mild cognitive impairment or dementia (Hill et al., 2017) and without those diagnoses (Lampit, Hallock, & Valenzuela, 2014; Chiu et al., 2017). Although it seems that computerized training is effective, safe and secure, it is important to note the social component of the definition of health (OMS, 1948). Chang, Wray & Lin (2014) found that social relationships predict the use of leisure activities and this predict a better physical health and wellbeing psychological. In fact, a comparative study found that those elderly people that have played board games have a 15% lower risk of having dementia diagnose and problems related with memory (Dartigues et al., 2013). To sum up, the aim of this research project is to test the effectiveness of a cognitive training based on modern board and card games in elderly people with a diagnose of mild-cognitive impairment in comparison to do cognitive paper and pencil tasks or in a wait-list comparison group.

研究设计

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

入排标准

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

入选标准

  • Participation in cognitive disease center
  • Amnestic MCI diagnoses (clinical diagnoses following the guidelines of Petersen et al. 2011)
  • Global deterioration scale (GDS) 2-3 values
  • Participation assessing outcomes of the caregivers in the study

排除标准

  • Participation in another cognitive training program
  • Dementia, neurologic or other disease non-neurodegenerative, which could affect cognitive change over time (medical-reported)
  • Severe visual impairment, language impairment or motoric impairment of the upper extremity which significantly affects ability to solve jigsaw puzzles (medical-reported)

结局指标

主要结局

Change in visuospatial short-term memory from baseline to post intervention

时间窗: Baseline and post intervention (after 16 weeks)

Visual Memory Test Forward

Change in visuospatial processing from baseline to post intervention

时间窗: Baseline and post intervention (after 16 weeks)

Trail Making Test A and Symbol Digit Modalities Test (SDMT)

Change in cognitive impairment from baseline to post intervention

时间窗: Baseline and post intervention (after 16 weeks)

Addenbrooke's Cognitive Examination

Change in visuoconstruction, immediate memory and long-term memory from baseline to post intervention

时间窗: Baseline and post intervention (after 16 weeks)

Copy, draw after 3 and after 25 minuts of Rey-Osterrieth Complex Figure Test

Change in verbal long-term memory from baseline to post intervention

时间窗: Baseline and post intervention (after 16 weeks)

Rey Auditory Verbal Learning Test (RAVLT)

Change in visuospatial working memory from baseline to post intervention

时间窗: Baseline and post intervention (after 16 weeks)

Visual Memory Test Backward

Change in flexibility from baseline to post intervention

时间窗: Baseline and post intervention (after 16 weeks)

Trail Making Test B and 5 digits test

Change in phonemic and semantic fluency from baseline to post intervention

时间窗: Baseline and post intervention (after 16 weeks)

Animals category and P, M, R letters, Spanish version

Change in inhibition from baseline to post intervention

时间窗: Baseline and post intervention (after 16 weeks)

5 digits test

Change in verbal short-term memory from baseline to post intervention

时间窗: Baseline and post intervention (after 16 weeks)

Digit Memory Test Forward

Change in verbal working memory from baseline to post intervention

时间窗: Baseline and post intervention (after 16 weeks)

Digit Memory Test Backward

次要结局

  • Change in neuropsychiatric symptoms from baseline to post intervention(Baseline and post intervention (after 16 weeks))
  • Change in psychological well-being from baseline to post intervention(Baseline and post intervention (after 16 weeks))
  • Change in depressive symptoms from baseline to post intervention(Baseline and post intervention (after 16 weeks))

研究者

发起方
Brain In Game scientific-technical service
申办方类型
Other
责任方
Principal Investigator
主要研究者

jaume march llanes

Effectiveness on Cognition of a Cognitive Training Intervention Based on Modern Board and Card Games in Mild Cognitive Impairment Patients: a Randomized Controlled Trial

Brain In Game scientific-technical service

研究点 (4)

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