Effects of an Exercise Snacking Intervention on Cognitive Function in Patients With Mild Cognitive Impairment: A Nationwide Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 24
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the exercise intervention, participants and intervention personnel cannot be blinded to group assignment. Outcome assessors will remain blinded to group allocation throughout the study. Participants will be instructed not to disclose their group assignment to the outcome assessors.
入排标准
- 年龄范围
- 51 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Baduanjin-Based Exercise Snacking (Behavioral)
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.
干预措施: Baduanjin-Based Exercise Snacking (Behavioral)
结局指标
主要结局
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 24
时间窗: 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.
次要结局
- Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 12(Baseline and Week 12)