Effects of an Exercise Snacking Intervention on Cognitive Function in Patients With Mild Cognitive Impairment: A Nationwide Multicenter Randomized Controlled Trial (ES-MCI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Baduanjin-Based Exercise Snacking

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoli Wang, PhD; Phone Number: +8619526438101; Email: wang18249277812@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 51 to 80 years, inclusive.

2. Meet the NIA-AA core clinical criteria for probable amnestic mild cognitive impairment (aMCI), including all of the following:

   1. A self-reported and/or informant-reported history of progressive memory decline lasting for more than 6 months, confirmed by a study neurologist;
   2. Objective impairment in one or two cognitive domains on standardized neuropsychological testing, with memory impairment required;
   3. Montreal Cognitive Assessment (MoCA) score of 18-26;
   4. Cognitive impairment does not result in significant functional dependence, with instrumental activities of daily living (IADL) remaining normal or only mildly impaired;
   5. Does not meet diagnostic criteria for any type of dementia.
3. Able to independently use a smartphone and complete online check-ins, questionnaires, and other digital assessment tasks.
4. Able to walk independently without assistance.
5. 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.
6. Willing and able to provide written informed consent.
7. A primary caregiver, if applicable, is informed of and supportive of study participation.
8. Willing and able to comply with the 24-month follow-up schedule and complete all study assessments and intervention tasks.
9. 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:

1. Cognitive impairment attributable to other causes, including:

   1. Meeting clinical diagnostic criteria for Alzheimer's disease or another type of dementia;
   2. 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).

2. Severe or unstable medical conditions, including any of the following:

   1. Acute cardiovascular or cerebrovascular event within the previous 6 months, including myocardial infarction, unstable angina, stroke, or transient ischemic attack;
   2. New York Heart Association (NYHA) class III or IV heart failure;
   3. Poorly controlled hypertension, defined as resting blood pressure ≥180/110 mmHg;
   4. Poorly controlled diabetes mellitus, defined as HbA1c >9.0%;
   5. Severe musculoskeletal disease resulting in inability to walk continuously for more than 100 meters;
   6. Severe respiratory disease;
   7. Malignancy with an estimated life expectancy of less than 2 years.
3. 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.

4. High risk of falls, defined by any of the following:

   1. Two or more unprovoked falls during the previous year;
   2. A score of 0 on the balance component of the Short Physical Performance Battery (SPPB), indicating inability to stand with the feet together;
   3. Requirement for routine use of a walking aid or wheelchair.
5. Current participation in another clinical trial that may affect cognitive function or physical activity.
6. Planning to relocate outside the study area for more than 3 months during the next 24 months.
7. Any other condition that, in the investigator's judgment, may compromise participant safety, data integrity, or adherence to the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Baduanjin-Based Exercise Snacking; 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.
Active Comparator: 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.	Behavioral: Baduanjin-Based Exercise Snacking; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to 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

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Xiaoli Wang, PhD, Peking University

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 16, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise Intervention; Cognitive Function; Exercise Snacking; Baduanjin
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Behavior; Cognitive Dysfunction; Motor Activity
• Other Study ID Numbers: IRB00001052-26132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No