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临床试验/NCT03911765
NCT03911765Unknown1 期

Effect of Digital Cognitive Training on the Functionality of Older Adults With Mild Cognitive Impairment (MCI)

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月2日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
40
试验地点
1
主要终点
Performance in everyday living score change

研究概览

简要总结

The purpose of this study is to investigate the effect of digital cognitive training in the functionality of older adults with Mild Cognitive Impairment.

详细描述

Mild Cognitive Impairment (MCI) is characterized by decline in one or more cognitive domains, including memory, attention, executive functions, language and visuospatial abilities, and in a significant portion of cases may evolve to Alzheimer's Disease. According to established diagnostic criteria, independence for daily life activities is preserved, but activities are carried out less effectiveness and efficiency, affected subjects usually take more time and make more mistakes, when compared to their pre-morbid performance. Different studies have observed that impairments in functional performance in older adults with MCI are associated with impairments in executive function. This study intends to verify the impact of the use of digital cognitive training for executive function on the functionality of older adults with MCI. Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform. The active control group will play computer games available online. Both groups will play for 1 hour at least 2 times per week.

After baseline assessments, older adults with MCI will be stratified by age, education, gender, functional measurement and cognitive assessment, and randomly assigned to the intervention group with digital cognitive exercises or to the control group with computer games, in a stepped wedge design. Subjects will be evaluated at baseline and after completing 10 and 20 hours of intervention. After the first 10 hours of intervention both groups will be assigned to the intervention with digital cognitive exercises for additional 10 hours. Both groups will be comparable in terms of personal contact with staff and computer time. Our hypothesis is that the training using digital cognitive exercises will improve the executive function and that this gain has a positive impact on the functionality and accomplishment of the daily life activities of older adults with MCI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • •Age above 65 years old;
  • •Elderly enrolled in home for aged in wich the research is taking place;
  • •Montreal Cognitive Assessment above 21 points;

排除标准

  • •Clinical diagnosis of Alzheimer's Disease;
  • •Serious medical or neurological condition preventing from participation in the study;

研究组 & 干预措施

Executive Function cognitive training

Experimental

20 hours of digital cognitive training targeting executive function.

干预措施: digital cognitive training (Behavioral)

Games

Active Comparator

10 hours of computer games c available online which do not involve a high demand in cognitive functions (e.g. fishing game, pinball game, tetris, etc), followed by 10 hours of of digital cognitive training targeting executive function.

干预措施: digital cognitive training (Behavioral)

结局指标

主要结局

Performance in everyday living score change

时间窗: 3 months

Performance in everyday living score change will be measured using Canadian Occupational Performance Measure (COPM). The Canadian Occupational Performance Measure (COPM) has a client-centered design and measures outcomes according to three occupational performance areas (self-care, productivity, and leisure), examining self-perceived changes in the occupational performance of patients through a semistructured interview. At the beginning, patients start by identifying their difficulties according to the three occupational performance areas. They subsequently use a 10-point scale, ranging from not at all crucial (1) to extremely crucial (10), to identify the intensity of certain difficulties. For the top five problems or tasks selected by patients, the interviewer asks them to continue identifying their performance and satisfaction with their performance by using the same 10-point rating scale.

次要结局

  • Functional status score change(3 months)

研究者

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

Rogerio Panizzutti

Director, Clinical Research

Universidade Federal do Rio de Janeiro

研究点 (1)

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