Evaluation of the Effect of Healthy Lifestyle Intervention for Patients With Mild Cognitive Impairment

Official title

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

Overview

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.

Detailed description

Research Background

1. 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.

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. 3. Research Status and Significance Current research on healthy lifestyle interventions for MCI patients is limited, with most studies focusing on single interventions rather than comprehensive approaches.

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

1. Perspective Innovation Starting from an overall healthy lifestyle and focusing on MCI patients, this study integrates multi-factorial interventions (exercise, diet, social interaction, and cognitive training), breaking the limitations of traditional single-factor research. Meanwhile, the intervention effects are evaluated from multiple dimensions to comprehensively measure the impact of lifestyle interventions on MCI patients. 2. Methodological Innovation Combining multi-modal interventions (cognitive training, exercise, MIND diet, group social activities) with digital technology (cognitive digital therapy, fitness trackers for heart rate monitoring), this study enables real-time multi-dimensional monitoring and data collection, enhancing intervention compliance and engagement. 3. Application Innovation Focusing on modifiable factors in the lives of MCI patients, this study designs practical interventions that can be implemented in both family and community settings. Based on the research findings, an integrated promotion model of "hospital-community-family" can be established to effectively improve the accessibility and sustainability of the interventions. 4. Research Framework Innovation This study constructs a comprehensive intervention framework that integrates diet, exercise, cognition, and social interaction, providing a reference for future research.

Interventions

• Behavioral Exercise intervention
  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: 1. Warm-up preparation (3 minutes) : Warm up the
• Behavioral Social intervention
  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 a
• Behavioral Dietary intervention
  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
• Behavioral Cognitive intervention
  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.
• Behavioral Health Education Manual
  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.

Primary outcome measures

• Participation rate [Time frame: Baseline]
• Study Measures Completion [Time frame: 4 weeks and 8weeks]
• Montreal Cognitive Assessment [Time frame: Baseline and 8 weeks]
• Mini-Mental State Examination [Time frame: Baseline and 8 weeks]

Secondary outcome measures (6)

• 12-item Short-Form Health Survey [Time frame: Baseline and 8 weeks]
• Social Support Rating Scale [Time frame: Baseline and 8 weeks]
• Geriatric Depression Scale [Time frame: Baseline and 8 weeks]
• General information questionnaire [Time frame: Baseline]
• Satisfaction Questionnaire [Time frame: 8weeks]
• Occurrence of adverse events [Time frame: From enrollment to the end of the intervention at eight weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Xuanwu Hospital, Capital Medical University — Beijing

Publications

• Zhang Lixiu, Liu Xueqin. Study on the reliability and validity of the Chinese version of the Montreal Cognitive Assessment Scale J. Nursing Research, 2007, (31): 2906-7.
• The theoretical basis and research application of Social Support Rating Scale J. Journal of Clinical Psychiatry, 1994, (02): 98-100.
• Zhou Xiaoxuan, Xie Min, Tao Jing, et al. Research and application of simple intelligent mental state examination scale J. Chinese Journal of Rehabilitation Medicine, 2016, 31(06): 694-696.
• Mitchell AJ, Bird V, Rizzo M, Meader N. Diagnostic validity and added value of the Geriatric Depression Scale for depression in primary care: a meta-analysis of GDS30 and GDS15. J Affect Disord. 2010 Sep;125(1-3):10-7. doi: 10.1016/j.jad.2009.08.019. Epub 2009 Oct 2. PMID 19800132
• Sheikh J. Geriatric depression scale (GDS): recent evidence and development of ashorter version J. Clin Gerontol, 1986, 5(1): 165-173.
• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. PMID 8628042
• Chinese Expert Consensus Committee on Brain and Cognitive Health Management, Editorial Committee of Chinese Journal of Health Management. Chinese expert consensus on brain cognitive health management (2023) J. Chinese Journal of Health Management, 2023, 17(12): 881-892.
• Special Committee of Neurodegeneration, Chinese Society of Microcirculation, Neuropsychological and Behavioral Neurology Group, Chinese Society of Neurology, Neurorehabilitation Group, Chinese Society of Neurology. Chinese expert consensus on rehabilitation management of Alzheimer's disease J. Chinese Journal of Gerontology, 2020, 39(1): 9 19.

Identifiers

NCT: NCT06942780 · 202504

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗