Preliminary Efficacy and Feasibility Analysis of Cognitive Training, Group Social Activities, Physical Exercise, and MIND Diet in Patients With Mild Cognitive Impairment

Xuanwu Hospital, Beijing1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2025年5月1日最近更新: 2025年5月9日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Xuanwu Hospital, Beijing
入组人数: 30
试验地点: 1
主要终点: Participation rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This clinical study aims to evaluate the feasibility and preliminary effectiveness of a comprehensive lifestyle intervention program for patients with mild cognitive impairment. The intervention consists of four components: cognitive training, physical exercise, MIND diet, and group social activities.

The hypothesis is that this integrated healthy lifestyle intervention may slow cognitive decline, improve daily functional abilities, and enhance the quality of life in MCI patients. Feasibility will be assessed based on participation rates, program completion rates, and participant satisfaction. Effectiveness will be evaluated using scales such as MoCA, MMSE.

The study participants will be clinically diagnosed mild cognitive impairment patients. If feasibility is confirmed, the results will provide a basis for larger-scale clinical trials and offer insights into non-pharmacological intervention strategies for brain health in high-risk populations.

详细描述

Research Background

MCI Status and Impact Mild Cognitive Impairment (MCI) is an intermediate state between normal aging and dementia, characterized by cognitive decline. Globally, the prevalence of MCI among individuals aged 65 and older is approximately 15%-20%, while in China, the prevalence among those aged 60 and older is 15.5%, affecting approximately 38.77 million people.

MCI patients experience cognitive decline, reduced quality of life, and increased economic burden on families (approximately 20%-30% higher than healthy elderly individuals). The prevalence of depressive symptoms in MCI patients is significantly higher than in healthy elderly individuals.

MCI patients have a high risk of progressing to dementia, with an annual conversion rate of 10%-15%, and up to 50% progressing within five years. However, early intervention can reverse or delay the progression to dementia. 2. Importance of Healthy Lifestyle Interventions. A healthy lifestyle, including observable behaviors (e.g., diet, exercise) and indirect behaviors (e.g., psychological state, cognitive ability), plays a significant role in preventing and intervening in MCI.

Exercise Intervention: Regular exercise (e.g., brisk walking, resistance training, Tai Chi) improves cognitive function. It is recommended that older adults with cognitive decline engage in 150-300 minutes of moderate-intensity activity per week.

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: Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

性别: All
接受健康志愿者: 否

入选标准

•To meet the diagnostic criteria of MCI, refer to the diagnostic criteria of MCI in "2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment (5) : Diagnosis and Treatment of Mild Cognitive Impairment".
•Have caregiver > 6 months.
•Participate in the study voluntarily and sign the informed consent.

排除标准

•Have received other cognitive intervention therapy recently (within 6 months).
•Diagnosis of functional encephalopathy or obvious mental disorders, such as Parkinson's disease, epilepsy, schizophrenia.
•Suffering from serious cardiovascular diseases, malignant tumors and other major physical diseases.
•Have visual, hearing, speech or limb dysfunction, unable to complete the test.
•Patients with chronic diseases who have special dietary needs or require special dietary management.

研究组 & 干预措施

the usual care group

Sham Comparator

The usual care group was given a health education booklet on the importance of proper diet, physical activity, cognitive exercise, and social interaction to help participants establish a basic understanding of these healthy lifestyles and try to do them. The manual teaches about common healthy ingredients, the appropriate frequency and intensity of aerobic exercise, and the benefits of brain games, reading, and learning new skills. And specific forms of social communication, such as participation in community activities, regular gatherings with relatives and friends.

干预措施: Health Education Manual (Behavioral)