Yizhi Baduanjin for Patients With Cognitive Impairment

The Validation and Beneficial Effects of Yizhi Baduanjin for Patients With Mild Cognitive Impairment: a Pilot Randomised Controlled Trial

The trial is designed to examine whether Yizhi Baduanjin could slow down and improve in memory, logical thinking and cerebral function in patients with mild cognitive impairment (MCI). 30 MCI patients will be recruited and randomly assigned to Yizhi Baduanjin intervention group control group for 6 months. The primary outcome is changes in Montreal Cognitive Assessment (MoCA) questionnaire; other outcome includes Cognitive Function Assessment questionnaire.

Study Overview

• Status: Terminated
• Conditions: Mild Cognitive Impairment (MCI)
• Intervention / Treatment: Other: Yizhi Baduanjin (Eight Pieces of Brocades for Mental Health Promotion)

Detailed Description

Alzehimer Disease (AD), generally known as dementia, is system of pathological changes of the central nervous system, with the major symptoms of progressive memory loss, cognitive disorder, personality changes and difficulty speaking. Mild Cognitive Impairment (MCI) is always regarded as "prodromal AD", and as a stage of AD in the revised diagnostic guidelines. It is a condition with minor memory decline, and minor difficulties with attention and learning. MCI patients have a much higher risk of progress to AD than the general population. AD increases along with aging, while aging is a worsening global issue. The onset of AD is difficult to recognize, and the progression is non-reversible and without cure, while the intervention during the MCI stage would be effective for preventing the progression to AD. The pathogenesis of MCI is yet to be investigated, so the pharmaceuticals are under debate. The non-drug therapies have few side effects and are more acceptable to patients, The investigators believe that Yizhi Baduajin, a newly complied routine based on the traditional Chinese medical health practice Baduanjin, is a possible intervention to prevent MCI and AD which could be practiced for long-term. Therefore, this pilot controlled trial is proposed to verify the effect of Yizhi Baduanjin and investigate how it improve and promotes mental and cerebral functions, and to explore and develop a replicable model of Yizhi Baduanjin MCI service package that includes MCI screening and education, as well as the Yizhi Baduanjin teaching.

The hypothesis is that the progression of MCI patients who practice Yizhi Baduanjin will slow down and improve in memory, logical thinking and cerebral function than MCI patients who do not practice. Also, Yizhi Baduanjin is a more acceptable intervention for middle-aged and elderly people, it is also easier to popularize in replicable model at a lower cost.

The trial will recruit 30 participants, and divide randomly into two groups with 15 participants each. The experimental group will practice Yizhi Baduanjin as an intervention for 6 months, and the participants will be examined for assessment indicators on the 1st, 3rd, 6th month after the intervention starts. The control group has no intervention until 6 months after the intervention of the experimental group started, but the participants will be examined for the same assessment indicators together with the experimental group. The Montreal Cognitive Assessment (MoCA) questionnaire and Cognitive Function Assessment questionnaire will be used as the assessment instruments, and data collected from the two groups will be compared and assessed.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. 60 to 75 years old.
2. Voluntarily and sign the informed consent form.
3. Non-handicapped, able to complete the cognitive function examination.
4. Fulfill the diagnostic criteria.
5. Montreal Cognitive Assessment (MoCA )Scale < 26

Exclusion Criteria:

1. Fail to meet the inclusion criteria.
2. Fail to comply to the requirements, or fail to complete the examination.
3. Unwilling or unable to learn and practice the Yizhi Baduanjin routine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yizhi Baduanjin group; The Yizhi Baduanjin group will practice Yizhi Baduanjin as intervention for 6 months, and the participants will be examined for assessment indicators on the 1st, 3rd, 6th month after the intervention started.	Other: Yizhi Baduanjin (Eight Pieces of Brocades for Mental Health Promotion); Yizhi Baduanjin (Eight Pieces of Brocades for Mental Health Promotion) is a newly compiled routine developed on the foundation of the traditional Baduanjin (Eight Pieces of Brocades), which is a traditional Chinese medical health exercise consisted of eight movements to be practiced by oneself.
No Intervention: Control group; The control group has no intervention until 6 months after the intervention of the experimental group started, but the participants will be examined for the same assessment indicators together with the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Montreal Cognitive Assessment (MoCA )	Questionnaire with 8 categories, 33 items with a total score of 30.	Baseline, 1-month, 3-month, 6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Cognitive Function Assessment	Questionnaire with 4 Categories, total items and scores vary according to participants' response.	Baseline, 1-month, 3-month, 6-month

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Zhangjin Zhang, MMed, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment (MCI); Baduanjin; Alzheimers Disease (AD); Non-drug intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: UW23-082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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