Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453941
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-04-10
Brief Title:
Yizhi Baduanjin for Patients With Cognitive Impairment
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
The Validation and Beneficial Effects of Yizhi Baduanjin for Patients With Mild Cognitive Impairment a Pilot Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None