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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age51-80
SponsorPeking University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 51 to 80 years, inclusive.

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;

Disqualifiers

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).

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Baduanjin-Based Exercise Snacking

    Behavioral

    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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Baduanjin Exercise Snacking GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and Week 24

Secondary outcomes

1

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.

Time frame
Baseline and Week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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