Effects of a Personalised and Tailored Computerised Cognitive Stimulation Programme Versus Stimulating Leisure Activities in Older Adults with Mild Cognitive Impairment and Subjective Cognitive Impairment: Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Lobo Cognitive Mini-Test (MEC-35)
研究概览
简要总结
The aim of the study is to evaluate, at the level of global cognition, cognitive neuroconstructs, memory, verbal fluency, ADLs, IADLs, symptoms of depression and anxiety, the effectiveness of a personalised and adapted computerised cognitive stimulation programme (GI1) implemented from Primary Care versus stimulating leisure activities (GI2), in older adults aged 50 years and over with mild cognitive impairment and subjective cognitive impairment living in the community.
详细描述
A randomised controlled trial (RCT) will be conducted. The sample will consist of 59 participants aged 50 years and older, all of whom are patients in primary care practices.
Intervention Intervention group 1 (IG1) will carry out personalised and adapted computerised CE through the stimulus platform; 30 minutes/day, 5 days/week, 8 weeks; 40 sessions. The following will be worked on: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions. Stimulus is a CE platform, which allows individualised intervention through the use of ICTs with different populations.
Intervention group 2 (IG2) will perform between 2 and 5 cognitively stimulating leisure activities for 8 weeks. These leisure activities will be selected from the adapted version of the Karp et al. 2006 questionnaire (Karp et al., 2006) taking into account the three components of leisure activities (mental, physical and social). The questionnaire contains 29 activities [1) reading, 2) arts and crafts, 3) crosswords and word search puzzles, 4) interest in politics, 5) playing cards or chess, 6) visiting the second home, 7) attending courses, 8) watching television, 9) going to the theatre or concerts, 10) playing sports, 11) going to exhibitions or museums, 12) meeting friends, 13) walking, 14) listening to the radio, 15) travelling, 16) gardening, 17) painting, drawing or taking photos, 18) participating in family or charity activities, 19) outdoor activities, 20) collecting stamps or other items, 21) cooking, 22) writing, 23) doing housework, 24) attending religious activities, 25) playing musical instruments, 26) playing solitaire, 27) following the stock market or investing, 28) playing bingo, 29) singing].
In addition to indicating which cognitively stimulating leisure activities they perform on a weekly basis, participants in IG2 will indicate their daily frequency (< 30 min, 30min-1 hour, 1-2 hours, > 2 hours), commenting on whether they have carried them out individually or in a group. It will also be taken into account whether these activities were previously carried out according to their stage of life.
The control group (CG) will not receive any intervention during the study period. At the end of the study, the control group will be offered to participate in either of the following two interventions.
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
- Single (Outcomes Assessor)
盲法说明
The professionals responsible for the assessments will be blinded and will be different from the professionals carrying out the intervention. Both will be trained.
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 50 years old, resident in the community.
- •Diagnosis of MCI or having between 24 and 27 points on the MEC-35 (this score seems to indicate the presence of MCI) (Calero, M. D and Navarro, 2006).
- •Subjective cognitive impairment (score between 28-31 points on the MEC-35) (Gómez-Soria et al. 2023)
排除标准
- •Institutionalisation.
- •Taking acetylcholinesterase inhibitors as they may act on global cognition and/or cognitive functions.
- •Sensory deficits (deafness and blindness) preventing intervention.
- •Agitation.
- •Having received cognitive stimulation in the last 12 months.
结局指标
主要结局
Lobo Cognitive Mini-Test (MEC-35)
时间窗: Post-intervention (1 week), 3 months, 6 months, 12 months
The MEC-35 is one of the most widely used short cognitive tests for the study of cognitive abilities in the primary care setting. The MEC-35 assesses eight cognitive functions: temporal and spatial orientation (10 items), fixation memory (3 items), attention (3 items), calculation (5 items), short-term memory (3 items) and language and praxis (11 items) (Lobo et al. 1999) (figure 1). Its sensitivity is 89.8% and its specificity 83.9% (Calero MD, Navarro E, Robles P, 2000). Unlike the MMSE, the MEC-35 includes a series of three digits to repeat two similar items in reverse order. Subtraction is performed 3 by 3 from 30, instead of 7 by 7 from 100 (Folstein et al., 1975).
次要结局
- Test of Memory Alteration (T@M)(Post-intervention (1 week), 3 months, 6 months, 12 months)
研究者
Isabel Gómez-Soria
Assistant professor doctor
Universidad de Zaragoza
