Mild Cognitive Impairment (MCI)NCT06453941
Yizhi Baduanjin for Patients With Cognitive Impairment
A study testing Yizhi Baduanjin (Eight Pieces of Brocades for Mental Health Promotion) in people with Mild Cognitive Impairment (MCI), run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Yizhi Baduanjin (Eight Pieces of Brocades for Mental Health Promotion)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 to 75 years old.
- Voluntarily and sign the informed consent form.
- Non-handicapped, able to complete the cognitive function examination.
- Fulfill the diagnostic criteria.
- Montreal Cognitive Assessment (MoCA )Scale < 26
Who cannot join
- Fail to meet the inclusion criteria.
- Fail to comply to the requirements, or fail to complete the examination.
- Unwilling or unable to learn and practice the Yizhi Baduanjin routine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Yizhi Baduanjin (Eight Pieces of Brocades for Mental Health Promotion)
- Keywords
- Mild Cognitive Impairment (MCI), Alzheimers Disease (AD), Non-drug intervention, Baduanjin
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yizhi Baduanjin (Eight Pieces of Brocades for Mental Health Promotion)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Yizhi Baduanjin group | Experimental | 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. Receives: Other: Yizhi Baduanjin (Eight Pieces of Brocades for Mental Health Promotion) |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Changes in Montreal Cognitive Assessment (MoCA )
Questionnaire with 8 categories, 33 items with a total score of 30.
Measured: Baseline, 1-month, 3-month, 6-month
Secondary outcomes (1)
Changes in Cognitive Function Assessment
Questionnaire with 4 Categories, total items and scores vary according to participants' response.
Measured: Baseline, 1-month, 3-month, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 May 2023
- Primary completion1 Mar 2025
- Study completion1 Apr 2025
Why it stopped: Only 1 subject has been recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Zhang Zhang-Jin, The University of Hong Kong
- Investigators
- Zhangjin Zhang, MMed, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453941
- Sponsor's protocol ID
- UW23-082
- Status last verified
- Jun 2025
- First submitted
- 10 Apr 2023
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validation and Beneficial Effects of Yizhi Baduanjin for Patients With Mild Cognitive Impairment: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06453941
- Acronym / sponsor ID
- UW23-082
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Mild Cognitive Impairment (MCI), Alzheimers Disease (AD), Non-drug intervention, Baduanjin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only 1 subject has been recruited.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yizhi Baduanjin group | Experimental | Other: Yizhi Baduanjin (Eight Pieces of Brocades for Mental Health Promotion)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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60 to 75 years old.
- Voluntarily and sign the informed consent form.
- Non-handicapped, able to complete the cognitive function examination.
- Fulfill the diagnostic criteria.
- Montreal Cognitive Assessment (MoCA )Scale < 26
Key exclusion criteria (3 listed)
- Fail to meet the inclusion criteria.
- Fail to comply to the requirements, or fail to complete the examination.
- Unwilling or unable to learn and practice the Yizhi Baduanjin routine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Yizhi Baduanjin group |
Primary outcome
Changes in Montreal Cognitive Assessment (MoCA )
Time frame: Baseline, 1-month, 3-month, 6-month
Questionnaire with 8 categories, 33 items with a total score of 30.
1 secondary outcome
Changes in Cognitive Function Assessment
Time frame: Baseline, 1-month, 3-month, 6-month
Results and safety
The study was stopped early (reason given: Only 1 subject has been recruited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhangjin Zhang, MMed, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yizhi Baduanjin (Eight Pieces of Brocades for Mental Health Promotion) in people with Mild Cognitive Impairment (MCI), run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Only 1 subject has been recruited.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Montreal Cognitive Assessment (MoCA ) (time frame: Baseline, 1-month, 3-month, 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.