Cognitive Stimulation Program in Elderly With Normal Cognition: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 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 cognitive stimulation program maintain and / or improve their score of the 35-point 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 older adults aged 65 or over The intervention was carried out at the Foundation of Zaragoza (Spain), consisting of 10 sessions of 45 minutes/week during 10 weeks.with normal cognition 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. Prevention is essential to avoid cognitive aging and preserve higher mental functions.
From an economic perspective, it is estimated that people with mild cognitive impairment produce 16% more spending than those with normal cognition.
Cognitive stimulation is a low-cost non-pharmacological treatment that has shown its benefits in the preservation of cognitive aspects based on the brain plasticity it generates.
Our research is based on cognitive stimulation using the yellow and Orange Mental Activation notebooks, levels that correspond to the scores of Lobo's cognitive Mini-test. The book consists of 4 practical exercises that work on 10 cognitive aspects (memory, orientation, language, praxis, gnosis, calculation, perception, reasoning, attention and programming); in total 40 exercises. The models on which the laptop is based are 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)
- •Older people with an MEC between: 28-35 points with or without psychiatric pathology (depression, anxiety)
- •Non-Institutionalized People.
- •Older people with a Lawton index greater than or equal to 3.
排除标准
- •People who have received some type of cognitive stimulation therapy in the last year, that is, people who attend memory or mental activation workshops (in the major centers of the Zaragoza City Council, elderly associations, women's associations, etc. .).
- •People who present values of more than 6 points, in the abbreviated Goldberg anxiety scale and also in the Yesavage depression scale, score more than 12/15, due to presenting intense symptoms, which made it difficult to carry out the intervention.
研究组 & 干预措施
Group intervention
The experimental group consists of 101 participants have been subdivided into two groups of 25/26 that perform the same intervention but on a different day of the week.
The two subgroups have received 10 sessions of 45 minutes/week during 10 weeks. Each session included four parts: (a) Reality orientation therapy, (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.
.
干预措施: Cognitive stimulation (Behavioral)
Group Control
The control group consists of 100 participants. The no intervention group did not receive any type of 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
- Set Test(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 scale of Lawton & Brody (Lawton)(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
Isabel Gómez-Soria
Principal Investigator
Universidad de Zaragoza