Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06453941 |
| Other study ID # |
UW23-082 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
June 2024 |
| Source |
The University of Hong Kong |
| Contact |
Zhangjin Zhang, MMed, PhD |
| Phone |
+852 3917 6445 |
| Email |
zhangzj[@]hku.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. The primary outcome is changes in Montreal
Cognitive Assessment (MoCA) questionnaire; other outcome includes Cognitive Function
Assessment questionnaire.
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.
