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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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.

Hong Kong1 site
  • The University of Hong Kong

    Hong Kong, 000000

Other trials in Hong Kong

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.

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 groups in NCT06453941
Study groupRoleWhat they receive
Yizhi Baduanjin groupExperimentalThe 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 groupNo interventionThe 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.

  1. 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)
  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.

  1. First posted12 Jun 2024
  2. Study start1 May 2023
  3. Primary completion1 Mar 2025
  4. Study completion1 Apr 2025

Why it stopped: Only 1 subject has been recruited.

Resources

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)
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

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.

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