Multiple Interventions to Prevent Cognitive Decline (MIND-Matosinhos) - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Adherence to the Mediterranean diet
研究概览
简要总结
The present study aims to quantify the impact of a multidomain approach to prevent cognitive decline in individuals from the general population at-high risk of dementia. It will be based on five distinct components: 1) cognitive training; 2) physical exercise; 3) nutrition education; 4) capacitation to deal with cognitive decline; 5) assessment and correction of hearing loss.
详细描述
This is a community-based randomized controlled trial (RCT), which will be implemented in Matosinhos municipality (Portugal) and will be conducted over three months, possibly extensible up to 12 months.
Eligible individuals (n=300) will be randomized (1:1) into two arms: intervention and control groups. The intervention plan will be composed by five non-pharmacological strategies, namely: 1) cognitive training; 2) physical exercise; 3) nutrition education; 4) capacitation to deal with cognitive decline; 5) assessment and correction of hearing loss. This plan will be applied to both groups, but with lower intensity among the control group.
Participants' characteristics will be assessed at baseline and at three months; for those who complete one year of intervention, additional follow-ups at six and 12 months after the beginning of the intervention will be conducted. These evaluations will cover the following domains: sociodemographic, lifestyle, health and anthropometric characteristics; cognitive function; subjective memory complains; symptoms of anxiety and depression; quality of life; physical performance; levels of glycated hemoglobin and 24-hour urinary sodium, potassium, creatinine excretion as well as pH.
The results of the present study may guide future clinical practices and health policies aiming to prevent cognitive decline and reduce the overall burden of dementia.
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 (Outcomes Assessor)
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
- •Age 18-85 years;
- •Score equal or higher than the validated cutoff points defined as 2 standard deviations below the mean for age and education in the Montreal Cognitive Assessment (MoCA);
- •≥6 points on the Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score (CAIDE);
- •≥4 years of schooling.
排除标准
- •Medical disability that contraindicates physical activity;
- •Lack of autonomy in daily activities;
- •Previous diagnosis of dementia or severe incapacity.
结局指标
主要结局
Adherence to the Mediterranean diet
时间窗: Up to 12 months
Variation of participant's self-reported adherence to the Mediterranean diet, assessed using the Mediterranean food pattern scale (MEDAS), 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.
Self-reported quality of life
时间窗: Up to 12 months
Variation of participant's quality of life, assessed using the EuroQol Group scale - 5 dimensions (EQ-5D) scale, between the baseline assessment and the end of follow-up. This scale is subdivided in two subscales: a) five multiple choice questions, with five response possibilities, which produce a score that varies from 5 (best score) to 25 points (worst score); b) visual analogic scale, that varies from 0 (worst score) to 100 (best score).
次要结局
- Handgrip strength(Up to 12 months)
- Agility 1(Up to 12 months)
- Aerobic endurance(Up to 12 months)
- Levels of glycated hemoglobin(Up to 12 months)
- Lower body strength(Up to 12 months)
- Upper body flexibility(Up to 12 months)
- Lower body flexibility(Up to 12 months)
- Lower limb function(Up to 12 months)
- 24-hour urinary potassium excretion(Up to 12 months)
- Body mass index(Up to 12 months)
- Cognitive performance 1(Up to 12 months)
- 24-hour urinary sodium excretion(Up to 12 months)
- Agility 2(Up to 12 months)
- Memory complaints(Up to 12 months)
- Cognitive performance 2(Up to 12 months)
- Anxiety and depression(Up to 12 months)
- Agility 3(Up to 12 months)
- Upper body strength(Up to 12 months)
- Blood pressure(Up to 12 months)
- Adherence to each component of the intervention(Up to 12 months)
- Dropout(Up to 12 months)
- Functional capacity to perform instrumental activities of daily living(Up to 12 months)
- Implemented sessions(Up to 12 months)
- Time of follow-up(Up to 12 months)
- Complete assessment of participants(Up to 12 months)