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Clinical Trials in China / NCT06942780
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Evaluation of the Effect of Healthy Lifestyle Intervention for Patients With Mild Cognitive Impairment

NCT06942780 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Not applicable
Started
2025-05
Last updated
2025-05-09

Condition(s) studied

Mild Cognitive Impairment (MCI)

Investigational drug(s) / intervention(s)

Exercise interventionSocial interventionDietary interventionCognitive interventionHealth Education Manual

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 head and neck, shoulder joints, arms and wrists, waist and abdomen, thighs and ankles in turn, and perform 30 seconds for each movement. 2. Main training stage (60min) : aerobic exercise adopts basic steps of square dance or advanced step training; The resistance training module carries out compound resistance exercises of sitting posture, leg lift and arms forward lift. 3. Finishing and relaxing stage (12min) : select the traditional health exercise eight Duan Jin.

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 and praise the participants.

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 for supervision and feedback.

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.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 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". 2. Have caregiver \> 6 months. 3. Participate in the study voluntarily and sign the informed consent. Exclusion Criteria: 1. Have received other cognitive intervention therapy recently (within 6 months). 2. Diagnosis of functional encephalopathy or obvious mental disorders, such as Parkinson's disease, epilepsy, schizophrenia. 3. Suffering from serious cardiovascular diseases, malignant tumors and other major physical diseases. 4. Have visual, hearing, speech or limb dysfunction, unable to complete the test. 5. Patients with chronic diseases who have special dietary needs or require special dietary management.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing China

More Xuanwu Hospital, Beijing trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06942780 on ClinicalTrials.gov ↗ ← All trials in China