跳至主要内容
临床试验/NCT04041999
NCT04041999已完成不适用

Randomized Study of a Daily Cognition Training Program Versus Traditional Cognitive Stimulation in Older Adults

University of Salamanca1 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2016年1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
267
试验地点
1
主要终点
Cognitive function

研究概览

简要总结

HYPOTHESIS In older adults who receive a direct intervention from the perspective of occupational therapy with a "Training Program in Daily Cognition", there are greater benefits, both in the overall cognitive performance and in the levels of daily cognition, that in the older adults who receive an intervention based on a "Traditional Cognitive Stimulation Program", achieving not only an improvement or maintenance of cognitive functions, but a generalization and transfer of that improvement in their daily lives and occupational performance.

OBJECTIVES: To evaluate the effectiveness of a "Training Program in Daily Cognition" in the elderly, to improve the levels of daily cognition and global cognitive performance.

SPECIFIC OBJECTIVES:

Compare the difference in levels of daily cognition between the participants of the control group who carry out a "Traditional Cognitive Stimulation Program" and the participants of the experimental group who carry out a "Training Program in Daily Cognition".

Analyze if there is a difference in the levels of global cognitive performance between the participants of the control group that carry out a "Traditional Cognitive Stimulation Program" and the participants of the experimental group that carry out a "Training Program in Daily Cognition".

To study the relationship between standard psychometric tests that measure cognitive performance and the ECB Daily Cognition Battery Recognition Test that measures daily cognition.

Analyze if there is a relationship between age and cognitive performance and the daily cognition of the elderly.

Describe the relationship between the educational level that the participants possess and the cognitive performance and their daily cognition Evaluate the impact of gender in the elderly with cognitive performance and daily cognition.

Check whether or not physical activity influences the cognitive performance and daily cognition of study participants.

STUDY DESIGN: Experimental, randomized, stratified, prospective, longitudinal study using a parallel scheme of fixed allocation experimental group and control group.

The protocol has been authorized by the Ethics Committee of the Salamanca health area to make the project possible.

详细描述

OBJECTIVES To evaluate the effectiveness of a "Training Program in Daily Cognition" in the elderly, to improve levels of daily cognition and overall cognitive performance.

SPECIFIC OBJECTIVES:

  • Compare the difference in levels of daily cognition between the participants of the control group who carry out a "Traditional Cognitive Stimulation Program" and the participants of the experimental group who carry out a "Training Program in Daily Cognition".
  • To analyze if there is a difference in the levels of global cognitive performance between the participants of the control group that carry out a "Traditional Cognitive Stimulation Program" and the participants of the experimental group that carry out a "Training Program in Daily Cognition".
  • To study the relationship between the standard psychometric tests that measure cognitive performance and the Recognition Test (Declarative Memory) of the ECB Daily Battery of Cognition (Everday Cognition Battery), which measures daily cognition.
  • Analyze if there is a relationship between age and cognitive performance and the daily cognition of the elderly.
  • Describe the relationship between the educational level of the participants and cognitive performance and their daily cognition
  • Evaluate the impact of gender on the elderly with performance Cognitive and everyday cognition.
  • Check whether or not physical activity influences cognitive performance and daily cognition of study participants.

STUDY DESIGN Experimental, randomized, stratified, prospective, longitudinal study using a parallel scheme of fixed allocation experimental group and control group; in which the evolution of cognitive performance in individuals who voluntarily enrolled in the Occupational Therapy Program offered by HE. Salamanca City Council in different Senior Centers in the city of Salamanca.

The study was carried out over four years with three phases without intervention between them. Each intervention phase lasted 12 weeks. Participants were assessed at the beginning and at the end of each intervention period.

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 (Participant)

入排标准

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

入选标准

  • •Be at least 60 years of age and voluntarily enroll in the Occupational Therapy Program.
  • •Be accepted in the Occupational Therapy Program.
  • •Perform the initial assessment.
  • •Voluntarily authorize their participation in the study, by signing an informed consent.

排除标准

  • •Present cognitive impairment with clinical diagnosis.
  • •Not have numerical and literacy skills.
  • •Do not authorize your participation in the study.
  • •Participate in some other cognitive stimulation program regularly.

研究组 & 干预措施

Daily Cognition Training Program

Experimental

The intervention was administered by a qualified professional, in this case an occupational therapist. And it was always individually through specific activities or exercises.

Tasks are carried out in which the subject has to exercise different cognitive functions (praxies, attention, language, memory orientation, gnosias and executive functions; mainly working memory decision making, planning, reasoning and temporal estimation) during the development of AIVD For this, similar materials are used to those that the elderly could find in daily tasks or when solving day-to-day problems.

Specifically we focus on tasks related to taking medication and adherence to treatment.

干预措施: Daily Cognition Training Program (Behavioral)

Traditional Cognitive Stimulation Program

Active Comparator

The intervention was administered by a qualified professional, in this case an occupational therapist. And it was always individually through specific activities or exercises.

Tasks are performed to work various cognitive functions.

干预措施: Daily Cognition Training Program (Behavioral)

结局指标

主要结局

Cognitive function

时间窗: Up to 3 years

Rapid evaluation of cognitive functions (ERFC)

Everyday cognition

时间窗: Up to 3 years

Everyday Cognition Battery (ECB)

次要结局

未报告次要终点

研究者

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

Prof. Dr. Eduardo J Fernández Rodríguez

PhD. Occupational therapy. University of Salamanca.

University of Salamanca

研究点 (1)

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