Xuanwu Hospital, Capital Medical University
Beijing, 100053, China
NCT Number: NCT06942780
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.
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Interventional
Not applicable
Beijing, 100053, China
Research Background
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.
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.
Social Intervention: Active social participation (e.g., interest groups, health education) reduces the risk of cognitive decline. It is recommended that MCI patients participate in social activities at least twice a week.
Dietary Intervention: The MIND diet (a combination of the Mediterranean and DASH diets) emphasizes antioxidant and anti-inflammatory foods, reducing MCI risk and slowing age-related cognitive decline.
Cognitive Intervention: Cognitive training (e.g., digital cognitive therapy) is effective in improving intervention outcomes. It is recommended that MCI patients undergo at least 3 sessions per week, each lasting 30 minutes, with a total training time of no less than 20 hours.
This study combines exercise, social activities, diet, and cognitive training to systematically evaluate the comprehensive effects of multidimensional healthy lifestyle interventions. The findings will provide evidence for developing personalized and precise intervention strategies, helping to reduce the risk of dementia conversion, alleviate family and societal burdens, and promote healthy aging.
Statistical Methods The SPSS 23.0 statistical software was used to build the database and conduct statistical analyses. Descriptive statistics were applied to describe the basic characteristics of the study subjects and the outcome indicators of the feasibility analysis. For measurement data, the Shapiro-Wilk test was used to test for normality. Normally distributed data were described using means and standard deviations, while non-normally distributed data were described using medians and interquartile ranges. Categorical data were described using frequencies and percentages.
For the outcome indicators of the effectiveness validation of the study subjects, between-group differences were analyzed. Normally distributed data were analyzed using the independent samples t-test, while non-normally distributed data were analyzed using the Mann-Whitney U test. A two-tailed p-value ≤0.05 was considered statistically significant.
Innovations
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The multi-component exercise mode is adopted, and the three-stage structured design of "warm-up preparation - main training - finishing and relaxation" is adopted, and the participants' heart rate is monitored in real time with the exercise bracelet throughout the whole process to ensure that the training intensity is reached. The movement process is guided synchronously by the video music teaching system, and the specific process is as follows:
The duration of each intervention was 40min, mainly group social interaction, guided by professionals (medical social workers). Divided into three stages:
The first stage (3min) : The facilitator will go through small jokes, soothing music, etc.Create a relaxed atmosphere and briefly introduce the theme of the week.
The second stage (35min) : During the activity, participants began to chat around the theme, and the host guided them timely.
The third stage (2min) : Summarize the intervention and praise the participants.
The researcher distributed the health education manual of the cognitive disorder diagnosis and treatment center, and conducted a 5-minute MIND diet health education, explaining relevant dietary requirements and focusing on the collocation of one type of food every week. The participants were then given homework that asked them to strictly follow the MIND diet in their daily diet. At the same time, the participants' caregivers are required to upload photos of their daily meals to the wechat group for supervision and feedback.
Cognitive digital therapy was adopted, and participants were supervised by their caregivers for 5 days a week and 30min each time for cloud-based home training (avoiding 2 hospital intervention days) for 8 weeks. The training covers core cognitive functions such as attention, memory and logical reasoning.
Distribute health education handbooks to guide patients to establish a good awareness of a healthy lifestyle. The manual can popularize health knowledge, covering various aspects such as diet, exercise, and rest, enabling patients to understand the importance of a healthy lifestyle, encouraging them to actively improve their living habits, slow down the progression of the disease, and enhance their quality of life.
Time frame: Baseline
Recruitment success rate : number of people who agree to participate/total number of people eligible and invited
Time frame: 4 weeks and 8weeks
Number of participants with full protocol compliance, including: attending interventions as scheduled, verifying target exercise intensity via fitness trackers, and recording MIND diet adherence in the WeChat group.
Time frame: Baseline and 8 weeks
Seven sub-dimensions, including visuospatial/executive function, naming, attention, language, abstract ability, delayed recall and orientation, were scored out of 30, with higher scores indicating better cognitive ability. The sensitivity and specificity of the Beijing version of MoCA scale were 0.92, 0.84, 0.86, and 0.82 Cronbach'sa coefficient of internal consistency.
Time frame: Baseline and 8 weeks
The scale includes the assessment of orientation, attention and computing ability, immediate recall, delayed recall, language function and visuospatial ability. The total score is 30 points, the higher the score is, the better the cognitive function, >27 is normal, <27 is cognitive dysfunction. The Chinese MMSE retest reliability is 0.90.
Time frame: Baseline and 8 weeks
The total score of the scale ranges from 12 to 65 points. The higher the scale score, the better the quality of life. When the 12-item Short-Form Health Survey was applied to the elderly population in China, the Cronbach'sa coefficient of the scale was 0.775, indicating good reliability and validity.
Time frame: Baseline and 8 weeks
The scale consisted of 10 items and 3 dimensions (subjective support, objective support and utilization of social support), with a total score of 12 to 66 points, and the higher the score, the better the social support. The retest reliability of the scale was 0.92, and the prediction validity was good.
Time frame: Baseline and 8 weeks
Geriatric Depression Scale is adapted by Sheikh and other scholars on the basis of the standard edition, with a total of 15 items, each item is 1 point. The scale scores range from 0 to 15 points. The higher the score, the more likely it is to have depressive symptoms. The Chinese version of GDS-15 scale has good applicability in the elderly population in China, with a one-week retest reliability of 0.728 and a Cronbach'sa coefficient of 0.793.
Time frame: Baseline
demographic information (age, sex, education, marital status, etc.), health status (medical history, drug use, smoking and alcohol use), lifestyle (physical activity, eating habits, social activities).
Time frame: 8weeks
The satisfaction questionnaire covers four aspects (cognitive training, exercise, MIND diet and social activities), and gives the scores of acceptability (interest/difficulty), time commitment and overall satisfaction (5-point Likert scale), with a total score ranging from 13 to 65 points. The higher the score is, the more satisfied one will be. Open-ended questions will collect suggestions for improvement.
Time frame: From enrollment to the end of the intervention at eight weeks
The number of cases of falls and muscle injuries during exercise, indigestion and gastrointestinal reactions caused by following the MIND diet
Contact information is provided by the study sponsor or research team.
Xuanwu Hospital, Beijing
Other
Preliminary Efficacy and Feasibility Analysis of Cognitive Training, Group Social Activities, Physical Exercise, and MIND Diet in Patients With Mild Cognitive Impairment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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