Intervention Effect of Yizhi Baduanjin on Patients With Mild Cognitive Impairment

NCT05899777 | Unknown

• 1 other identifier: ZY(2021-2023)-0105-B99
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

With mild cognitive impairment (MCI) as the research object, the intervention effect of Yizhi Baduanjin on mild cognitive impairment was evaluated by using the Montreal Cognitive Assessment (MoCA) scale, human-computer interactive electronic cognitive function score, multi-measure EEG data and other evaluation indicators, with the intervention measures of Yizhi Baduanjin created by the Tai Chi Health Center in the early stage. This project is based on the preliminary study, followed the principles and methods of clinical epidemiology and evidence-based medicine, and designed a prospective, randomized, single-blind, parallel controlled trial to make up for the deficiency of existing drugs in the intervention of mild cognitive impairment, and to provide evidence for the clinical and community promotion and application of effective and safe traditional Chinese medicine non-pharmaceuticals in the prevention and treatment of mild cognitive impairment.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Baduanjin

Outcome Measures

Primary Outcomes (3)

• MoCA

  The MoCA (Montreal Cognitive Assessment) is a tool used to assess cognitive function, primarily for the early detection of mild cognitive impairment and dementia. The MoCA scale consists of 30 questions, including evaluations of memory, attention, language, abstraction, orientation, spatial ability, and executive function. The scale includes more specific testing items, such as clock-drawing, reaction time, and number string recall. Each question has a standard answer or scoring criteria, and scores are totaled to a maximum of 30 points.The cutoffs for MCI are \<26.

  Change from Baseline MOCA at 4 weeks

• MoCA

  The MoCA (Montreal Cognitive Assessment) is a tool used to assess cognitive function, primarily for the early detection of mild cognitive impairment and dementia. The MoCA scale consists of 30 questions, including evaluations of memory, attention, language, abstraction, orientation, spatial ability, and executive function. The scale includes more specific testing items, such as clock-drawing, reaction time, and number string recall. Each question has a standard answer or scoring criteria, and scores are totaled to a maximum of 30 points.The cutoffs for MCI are \<26.

  Change from 4 weeks MOCA at 12 weeks

• MoCA

  The MoCA (Montreal Cognitive Assessment) is a tool used to assess cognitive function, primarily for the early detection of mild cognitive impairment and dementia. The MoCA scale consists of 30 questions, including evaluations of memory, attention, language, abstraction, orientation, spatial ability, and executive function. The scale includes more specific testing items, such as clock-drawing, reaction time, and number string recall. Each question has a standard answer or scoring criteria, and scores are totaled to a maximum of 30 points.The cutoffs for MCI are \<26.

  Change from 12 weeks MOCA at 24 weeks

Secondary Outcomes (6)

• Cognitive Function Score

  Change from Baseline cognitive function score at 4 weeks

• Cognitive Function Score

  Change from 4 weeks cognitive function score at 12 weeks

• Cognitive Function Score

  Change from 12 weeks cognitive function score at 24 weeks

• EEG data

  Change from Baseline EEG data at 4 weeks

• EEG data

  Change from 4 weeks EEG data at 12 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

After proficiently mastering the complete set of Yizhi Baduanjin, the practice group is required to practice sitting posture of YizhiBaduanjin twice a day and standing posture of YizhiBaduanjin once every two days.

Other: Yizhi Baduanjin

control group

NO INTERVENTION

The control group is a waiting control group, and after 24 weeks, they will continue to learn the Yizhi Baduanjin.

Interventions

Yizhi Baduanjin OTHER

Yizhi Baduanjin is a newly compiled routine developed on the foundation of the traditional Baduanjin, aiming at the mental and cerebral health of middle-aged and elderly population, which combining the preliminary research result and principles of the traditional routine. It could be practiced in long term to prevent MCI and AD, or simply as a general health exercise for elders.

Treatment group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjective symptoms include memory loss
• MoCA score is less than 26 points
• No disability, no communication barrier, and can complete the cognitive function test of human-computer interaction
• Agree to participate in the project and sign the informed consent form

You may not qualify if:

• Alzheimer's patients
• Cognitive impairment caused by depression, cerebrovascular accident and other specific reasons
• Those who are unwilling or unable to take part in the Yizhi Baduanjin exercise

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: June 12, 2023
• Study Start: June 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share