Effects of an Exercise Snacking Intervention on Cognitive Function in Patients With Mild Cognitive Impairment: A Nationwide Multicenter Randomized Controlled Trial (ES-MCI)
2026年9月14日 更新者:Peking University
This multicenter randomized controlled trial aims to evaluate the effects of a Baduanjin-based exercise snacking intervention on cognitive function in older adults with mild cognitive impairment (MCI).
A total of 240 participants will be randomly assigned in a 1:1 ratio to an intervention group or a control group.
The control group will receive routine health education, while the intervention group will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education.
The exercise program consists of short bouts of Baduanjin practice distributed throughout the day to facilitate integration into daily life.
Assessments will be conducted at baseline and at weeks 12, 24, and 48.
The primary outcome is global cognitive function.
Secondary outcomes include specific cognitive domains, physical function, emotional status, sleep, and other health-related measures.
Exercise adherence, physical activity, and safety will also be evaluated.
研究概览
研究类型
介入性
注册 (估计的)
240
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Xiaoli Wang, PhD
- 电话号码:+8619526438101
- 邮箱:wang18249277812@163.com
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Aged 51 to 80 years, inclusive.
Meet the NIA-AA core clinical criteria for probable amnestic mild cognitive impairment (aMCI), including all of the following:
- A self-reported and/or informant-reported history of progressive memory decline lasting for more than 6 months, confirmed by a study neurologist;
- Objective impairment in one or two cognitive domains on standardized neuropsychological testing, with memory impairment required;
- Montreal Cognitive Assessment (MoCA) score of 18-26;
- Cognitive impairment does not result in significant functional dependence, with instrumental activities of daily living (IADL) remaining normal or only mildly impaired;
- Does not meet diagnostic criteria for any type of dementia.
- Able to independently use a smartphone and complete online check-ins, questionnaires, and other digital assessment tasks.
- Able to walk independently without assistance.
- No absolute contraindications to exercise, as determined by the Physical Activity Readiness Questionnaire or by a study physician when exercise-related risks are considered manageable.
- Willing and able to provide written informed consent.
- A primary caregiver, if applicable, is informed of and supportive of study participation.
- Willing and able to comply with the 24-month follow-up schedule and complete all study assessments and intervention tasks.
- Participants taking cognition-enhancing or other cognition-active medications may be included, provided that the medication dose has remained stable for at least 1 month before screening.
Exclusion Criteria:
Cognitive impairment attributable to other causes, including:
- Meeting clinical diagnostic criteria for Alzheimer's disease or another type of dementia;
- Cognitive impairment primarily attributable to another clearly identified condition, including neurodegenerative diseases (e.g., Parkinson's disease, Huntington's disease, progressive supranuclear palsy, or multiple sclerosis), severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, or major depressive episode with psychotic features), or systemic diseases (e.g., uncontrolled thyroid dysfunction or vitamin B12 deficiency).
Severe or unstable medical conditions, including any of the following:
- Acute cardiovascular or cerebrovascular event within the previous 6 months, including myocardial infarction, unstable angina, stroke, or transient ischemic attack;
- New York Heart Association (NYHA) class III or IV heart failure;
- Poorly controlled hypertension, defined as resting blood pressure ≥180/110 mmHg;
- Poorly controlled diabetes mellitus, defined as HbA1c >9.0%;
- Severe musculoskeletal disease resulting in inability to walk continuously for more than 100 meters;
- Severe respiratory disease;
- Malignancy with an estimated life expectancy of less than 2 years.
- Severe visual or hearing impairment that prevents the participant from adequately seeing assessment materials or hearing instructions despite the use of conventional corrective devices, such as glasses or hearing aids.
High risk of falls, defined by any of the following:
- Two or more unprovoked falls during the previous year;
- A score of 0 on the balance component of the Short Physical Performance Battery (SPPB), indicating inability to stand with the feet together;
- Requirement for routine use of a walking aid or wheelchair.
- Current participation in another clinical trial that may affect cognitive function or physical activity.
- Planning to relocate outside the study area for more than 3 months during the next 24 months.
- Any other condition that, in the investigator's judgment, may compromise participant safety, data integrity, or adherence to the study protocol.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Baduanjin Exercise Snacking Group
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education.
The intervention consists of brief, repeated bouts of Baduanjin exercise performed multiple times throughout the day.
Standardized instructional videos and digital support will be provided to facilitate intervention delivery and adherence.
|
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education.
The intervention consists of brief bouts of Baduanjin exercise distributed throughout the day and is adapted to the cognitive and physical characteristics of older adults with mild cognitive impairment.
Standardized instructional videos and digital support will be used to guide exercise performance and record intervention adherence.
Exercise intensity and safety will be monitored throughout the intervention period.
|
|
有源比较器:Control Group
Participants will receive routine health education during the 24-week intervention period and will not receive the prescribed Baduanjin-based exercise snacking intervention.
|
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education.
The intervention consists of brief bouts of Baduanjin exercise distributed throughout the day and is adapted to the cognitive and physical characteristics of older adults with mild cognitive impairment.
Standardized instructional videos and digital support will be used to guide exercise performance and record intervention adherence.
Exercise intensity and safety will be monitored throughout the intervention period.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 24
大体时间:Baseline and Week 24
|
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point cognitive screening instrument covering multiple cognitive domains.
Scores range from 0 to 30, with higher scores indicating better cognitive function.
The primary outcome is the change in MoCA score from baseline to Week 24.
|
Baseline and Week 24
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 12
大体时间:Baseline and Week 12
|
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point cognitive screening instrument covering multiple cognitive domains.
Scores range from 0 to 30, with higher scores indicating better cognitive function.
The outcome is the change in MoCA score from baseline to Week 12.
|
Baseline and Week 12
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Xiaoli Wang, PhD、Peking University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月15日
初级完成 (估计的)
2026年10月15日
研究完成 (估计的)
2027年12月15日
研究注册日期
首次提交
2026年9月14日
首先提交符合 QC 标准的
2026年9月14日
首次发布 (实际的)
2026年9月16日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.