跳至主要内容
临床试验/NCT03771131
NCT03771131已完成不适用

A Group Study on the Effects of a Short Multi-Domain Cognitive Training in Healthy Elderly Italian People

University of Milano Bicocca1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
Mean change from pre-training in Trail Making test scores

研究概览

简要总结

Alongside physiological cognitive ageing, nowadays there is an alarming increase in the incidence of dementia that requires communities to invest in its prevention. The engagement in cognitively stimulating activities and strong social networks have been identified among those protective factors promoting successful cognitive ageing. One aspect regarding cognitive stimulation concerns the relevance of the frequency of an external intervention. For these reasons, the aim of this study was to evaluate the efficacy of a 3-month multi-domain cognitive training program, administered once per week in a group of healthy elderly aged over 60 years old. Their results obtained on a series of neuropsychological tests, both pre- (t0) and post-training (t1), were compared with those of a passive control group who did not receive the cognitive training.

详细描述

Participants were assigned to the experimental or control group based on their time of application to the program. Both experimental and control group underwent a neuropsychological assessment to investigate different cognitive domains, before and after (~3 months) the training program. Based on the scores obtained during the preliminary neuropsychological assessment, the participants of the experimental training group were divided into small subgroups (ranging from 8 to 12 subjects) to further address individualization of training (i.e. level of difficulty of the exercises proposed). The experimental group attended weekly sessions of the multi-domain cognitive training. Each session lasted around one hour and the overall duration of the training was of 3 months, for a total of 13 sessions. To promote improvement transfer to everyday life, some of the exercises proposed were ecological in their nature, in that, they asked participants to solve tasks that recalled everyday situations (such as remembering names or road maps). Furthermore, throughout the training, approximately once every two sessions brief psycho-educational interventions were provided.

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
None

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age over 60 years

排除标准

  • •Negative anamnesis for neurological and/or psychiatric diseases
  • •No suspected cognitive impairment as assessed during the pre-training neuropsychological testing (>2 pathological scores)

研究组 & 干预措施

Control group

No Intervention

Passive control group

Experimental group

Experimental

Group receiving the multi-domain cognitive training

干预措施: Multi-domain cognitive training (Behavioral)

结局指标

主要结局

Mean change from pre-training in Trail Making test scores

时间窗: Pre- and post-training (after ~3 months of training)

Raw score, assessing attention. Cutoff: \> 93 (TMT A), \> 282 (TMT B), \> 186 (TMT B-A). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Stroop color and word test scores

时间窗: Pre- and post-training (after ~3 months of training)

Raw score, assessing inhibitory control. Cutoff: \> 36.92 (for Time measure), \> 4.24 (for Error measure). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Raven's coloured matrices scores

时间窗: Pre- and post-training (after ~3 months of training)

Raw score, assessing non-verbal reasoning. Cutoff: \< 18. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Short Story test scores

时间窗: Pre- and post-training (after ~3 months of training)

Raw score, assessing verbal long term memory. Cutoff: \< 7.5. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Semantic and Phonological Verbal Fluency scores

时间窗: Pre- and post-training (after ~3 months of training)

Raw score, assessing executive functions. Cutoff: \< 16 (Phonological), \< 24 (Semantic). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Montreal Congnitive Assessment (MoCA) scores

时间窗: Pre- and post-training (after ~3 months of training)

Raw score, assessing global cognitive functioning. Cutoff: \< 17.362. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Forward and Backward Digit and Corsi Span scores

时间窗: Pre- and post-training (after ~3 months of training)

Raw score, assessing verbal and visuo-spatial short term memory. Cutoff: \< 4.26 (Forward Digit Span), \< 2.65 (Backward Digit Span), \< 3.46 (Forward Corsi Span), \< 3.08 (Backward Corsi Span). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Copy and Recall of Rey-Osterrieth Complex Figure scores

时间窗: Pre- and post-training (after ~3 months of training)

Raw score, assessing constructional abilities and visuo-spatial long term memory. Cutoff: \< 28.87 (Copy), \< 9.46 (Recall). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

次要结局

  • Mean scores in the Post-training questionnaire(Post-training (after ~3 months of training))

研究者

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

Roberta Daini

Professor

University of Milano Bicocca

研究点 (1)

Loading locations...

相似试验