Multiple Interventions to Prevent Cognitive Decline
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adherence to the Mediterranean diet
研究概览
简要总结
The investigators aim to test the feasibility of a pragmatic non-pharmacological strategy, that may prevent cognitive decline in patients with mild cognitive impairment. This strategy is based on five different interventions: cognitive training, physical activity, nutrition education, adaption to memory loss, diagnosis and correction of hearing impairment.
A quasi-experimental study will be implemented in Porto (Portugal), including patients that fulfill all of the following criteria: a) age 18-85 years; b) Montreal Cognitive Assessment (MoCA) score greater than or equal to two standard deviations below the normative reference value for the corresponding age and education level in the Portuguese population OR diagnosis of Mild Cognitive Impairment, performed by a Neurologist, during the six previous months, considering the results of a neuropsychological battery; c) Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Dementia Risk Score of at least six points. Patients who have any medical disability that contraindicates physical activity or have a lack of autonomy in daily activities will be excluded.
The program will be implemented in groups of 10 participants, over a period of 10 consecutive months.
详细描述
Detailed description
This is a quasi-experimental study in which the investigators aim to test the feasibility of a non-pharmacological strategy to prevent cognitive decline in patients with a diagnosis of mild cognitive impairment. This strategy is based on five different interventions:
a) Cognitive training
This comprises training using using the cogweb software, both in person and remotely:
i) in person training: 30-minute sessions, supervised by a trained nurse, twice weekly .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a) Age 18-85 years;
- •b1) Montreal Cognitive Assessment score ≥ to two standard deviations below the normative reference value for the corresponding age and education level in the Portuguese population;
- •b2) clinical diagnosis of Mild Cognitive Impairment;
- •c) Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score ≥ six points.
排除标准
- •medical disability that contraindicates physical activity;
- •lack of autonomy in daily activities.
研究组 & 干预措施
Non-pharmacological intervention
Non-pharmacological strategy, implemented in groups of 10 participants, over 10 consecutive months, based on five different interventions:
cognitive training, physical activity; nutrition education; adaption to memory loss; detection and correction of hearing impairment.
干预措施: Cognitive training (Other)
Non-pharmacological intervention
Non-pharmacological strategy, implemented in groups of 10 participants, over 10 consecutive months, based on five different interventions:
cognitive training, physical activity; nutrition education; adaption to memory loss; detection and correction of hearing impairment.
干预措施: Physical activity (Behavioral)
Non-pharmacological intervention
Non-pharmacological strategy, implemented in groups of 10 participants, over 10 consecutive months, based on five different interventions:
cognitive training, physical activity; nutrition education; adaption to memory loss; detection and correction of hearing impairment.
干预措施: Nutrition education (Behavioral)
Non-pharmacological intervention
Non-pharmacological strategy, implemented in groups of 10 participants, over 10 consecutive months, based on five different interventions:
cognitive training, physical activity; nutrition education; adaption to memory loss; detection and correction of hearing impairment.
干预措施: Adaption to memory loss (Behavioral)
Non-pharmacological intervention
Non-pharmacological strategy, implemented in groups of 10 participants, over 10 consecutive months, based on five different interventions:
cognitive training, physical activity; nutrition education; adaption to memory loss; detection and correction of hearing impairment.
干预措施: Diagnosis of hearing impairment (Diagnostic Test)
结局指标
主要结局
Adherence to the Mediterranean diet
时间窗: 10 months
Variation of participant's self-reported adherence to the Mediterranean diet, assessed using the Mediterranean food pattern (PREDIMED) scale, between the baseline assessment and the end of follow-up. This scale varies from 0 (lowest adherence to the Mediterranean diet) to 14 points (highest adherence to the Mediterranean diet). A score over 10 points indicates good adherence to the Mediterranean diet.
Number of steps
时间窗: 10 months
Variation of participant's number of steps, assessed using a portable accelerometer, between the baseline assessment and the end of follow-up.
Adherence to each intervention
时间窗: 10 months
Proportion of adherence to each intervention and component of each intervention, calculated as the number of sessions attended/total number of sessions implemented. For remote cognitive training the outcome will be the absolute number of sessions.
Dropout
时间窗: 10 months
Proportion of participants who dropped out of the study, calculated as the number of participants who dropped out after attending at least one session/total number of participants who attended at least one session.
Cognitive performance 1
时间窗: 10 months
Variation of participant's cognitive performance assessed using the Montreal Cognitive Assessment, between the baseline assessment and the end of follow-up. This scale varies from 0 (worst cognitive performance) to 30 points (best cognitive performance).
Body mass index
时间窗: 10 months
Variation of participant's body mass index between the baseline assessment and the end of follow-up.
次要结局
- Cognitive performance 2(10 months)
- Memory complaints(10 months)
- Anxiety and depression(10 months)
- Reported quality of life: EQ-5D scale(10 months)
- Handgrip strength(10 months)
- Agility 1(10 months)
- Agility 2(10 months)
- Time of follow-up(10 months)
- Implemented sessions(10 months)
- Complete assessment of participants(10 months)