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临床试验/NCT03831061
NCT03831061已完成不适用

Intervention Through Cognitive Stimulation in People Aged 65 or Older With Mild Cognitive Impairment in Primary Care

Universidad de Zaragoza0 个研究点目标入组 122 人开始时间: 2011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
122
主要终点
The Spanish versions of the Mini-Mental State Examination (MEC-35),

研究概览

简要总结

The participants who carry out our program of cognitive stimulation, deteriorate at a cognitive level more slowly and can improve their score of the Spanish version of 35 points of Mini-mental State of Folstein; Mini-exam Cognoscitive of Lobo.

详细描述

The aim of our research is to evaluate the effect of a cognitive stimulation program in people aged 65 or older with mild cognitive impairment (MCI) and compare it, in the short, medium and long term, with the evolution of other people, with the same characteristics and for which this intervention has not been carried out.

The significant increase in the number of people over 65 years of age in relation to the total population, suggests a significant increase in age-related pathologies. The problem that entails population aging increases when cognitive deterioration appears.

From an economic perspective, the cognitive deterioration of the elderly person is estimated to contribute to health expenses of almost ten times more compared to people of the same age with cognitive functions preserved. Different studies show that a considerable proportion of people with MCI have a high risk of developing dementia and Alzheimer's disease.

Cognitive stimulation is a treatment that has shown profitability and has been recommended as the treatment of choice in MCI.

Our research is based on a cognitive stimulation that uses the Red Book of Mental Activation. The book consists of 4 practical exercises that work 10 cognitive aspects (memory, orientation, language, praxis, gnosis, calculation, perception, reasoning, attention and programming); in total 40 exercises. The models on which the notebook is based is the cognitive model and the human occupation model.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Older adults (age ≥ 65)
  • •Community (not institutionalized)
  • •Mini-Examen Cognoscitive (MEC) score 24-27 points
  • •Barthel index > 60 points
  • •No received cognitive stimulation in the last year
  • •Hearing problems that interfere with the intervention
  • •Blindness or vision problems that interfere with the intervention
  • •Neuropsychiatric disorders (agitation, delusions or hallucinations)
  • •Motor difficulties that interfere with the intervention.

排除标准

  • •No agree to participate and no sign the informed consent.

研究组 & 干预措施

Cognitive stimulation

Experimental

10 sessions of 45 minutes/week during 10 weeks. Each session included : (a) temporo-spatial orientation , (b) activities related to memory, orientation, language, praxis, gnosis, calculation, perception, reasoning, visual attention, and executive functions, (c) individual practical exercises and (d) correction of the practical exercises.

There are 54 participants subdivided into two groups of 27 participants that perform the same intervention in different days of the week.

干预措施: Cognitive stimulation (Other)

Control group (No intervention)

No Intervention

There are 68 participants in total. These participants did not receive intervention.

结局指标

主要结局

The Spanish versions of the Mini-Mental State Examination (MEC-35),

时间窗: baseline and change in 1 week, 6 months, baseline and 12 moths

It is a reliable and used instrument for the evaluation of cognitive impairment. It meets criteria of "feasibility", "content validity", "procedural" and "construction". Test-retest reliability: weighted kappa = 0.667, sensitivity = 89.8%, and specificity = 83.9%; with the cutoff point 23/24. A score of 28 is considered the lower limit of normal performance in adult population; scores equal or less than 27 would denote cognitive deficits.

次要结局

  • The scale of Lawton & Brody (Lawton)(baseline and change in 1 week, 6 months, baseline and 12 moths)
  • The Goldberg questionnaire (EADG)(baseline and change in 1 week, 6 months, baseline and 12 moths)
  • The Barthel Index (Barthel)(baseline and change in 1 week, 6 months, baseline and 12 moths)
  • The abbreviated Yesavage depression scale (GDS-15)(baseline and change in 1 week, 6 months, baseline and 12 moths)

研究者

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

Isabel Gómez-Soria

Clinical Professor

Universidad de Zaragoza

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