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Intervention Effect of Yizhi Baduanjin on Patients With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yizhi Baduanjin
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Baduanjin

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment group

    control group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Cognitive Function Score
    Objective scores for the four cognitive tasks of "positional circle", "numerical circle", "numerical string", and "operation" in the MCI screening tool.
    Cognitive Function Score
    Objective scores for the four cognitive tasks of "positional circle", "numerical circle", "numerical string", and "operation" in the MCI screening tool.
    Cognitive Function Score
    Objective scores for the four cognitive tasks of "positional circle", "numerical circle", "numerical string", and "operation" in the MCI screening tool.
    EEG data
    EEG power spectrum, ApEn approximate entropy, LZ complexity, RE, NR correlation
    EEG data
    EEG power spectrum, ApEn approximate entropy, LZ complexity, RE, NR correlation
    EEG data
    EEG power spectrum, ApEn approximate entropy, LZ complexity, RE, NR correlation

    Full Information

    First Posted
    April 17, 2023
    Last Updated
    June 1, 2023
    Sponsor
    Shanghai University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05899777
    Brief Title
    Intervention Effect of Yizhi Baduanjin on Patients With Mild Cognitive Impairment
    Official Title
    Research, Development and Promotion of the Service Package of Yizhi Baduanjin for Mild Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai University of Traditional Chinese Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Mild cognitive impairment(MCI) is a critical state between normal aging and dementia, with its core symptom being age-related cognitive decline. This critical state provides a window of opportunity for preventing Alzheimer's disease. At present, there is a lack of sufficient intervention methods to improve MCI. Yizhi Baduanjin is an adaptation of traditional Baduanjin, which is more suitable for middle-aged and elderly people to practice and optimize for improving cognitive function. Previous observations and studies have provided some evidence to prove the beneficial effect of Yizhi Baduanjin on MCI. This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 100 participants.They will randomly divided into two groups: the training group with 50 cases and the control group with 50 cases. The training group will receive intervention with the Yizhi Baduanjin, and various evaluation indicators will test before and 4、12、24 weeks after the intervention. The control group is a waiting control group, and after 24 weeks, they will continue to learn the Yizhi Baduanjin. The control group and the practice group will be tested simultaneously at four time points. Finally, the intervention effect will be evaluated through inter group and intra group comparisons of test data. The main research purpose is to evaluate the clinical effect of Yizhi Baduanjin on MCI.The secondary research objective is to explore the possible mechanism of Yizhi Baduanjin in improving MCI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment
    Keywords
    Mild Cognitive Impairment, Baduanjin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    The control group is a waiting control group, and after 24 weeks, they will continue to learn the Yizhi Baduanjin.
    Intervention Type
    Other
    Intervention Name(s)
    Yizhi Baduanjin
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    MoCA
    Description
    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.
    Time Frame
    Change from Baseline MOCA at 4 weeks
    Title
    MoCA
    Description
    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.
    Time Frame
    Change from 4 weeks MOCA at 12 weeks
    Title
    MoCA
    Description
    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.
    Time Frame
    Change from 12 weeks MOCA at 24 weeks
    Secondary Outcome Measure Information:
    Title
    Cognitive Function Score
    Description
    Objective scores for the four cognitive tasks of "positional circle", "numerical circle", "numerical string", and "operation" in the MCI screening tool.
    Time Frame
    Change from Baseline cognitive function score at 4 weeks
    Title
    Cognitive Function Score
    Description
    Objective scores for the four cognitive tasks of "positional circle", "numerical circle", "numerical string", and "operation" in the MCI screening tool.
    Time Frame
    Change from 4 weeks cognitive function score at 12 weeks
    Title
    Cognitive Function Score
    Description
    Objective scores for the four cognitive tasks of "positional circle", "numerical circle", "numerical string", and "operation" in the MCI screening tool.
    Time Frame
    Change from 12 weeks cognitive function score at 24 weeks
    Title
    EEG data
    Description
    EEG power spectrum, ApEn approximate entropy, LZ complexity, RE, NR correlation
    Time Frame
    Change from Baseline EEG data at 4 weeks
    Title
    EEG data
    Description
    EEG power spectrum, ApEn approximate entropy, LZ complexity, RE, NR correlation
    Time Frame
    Change from 4 weeks EEG data at 12 weeks
    Title
    EEG data
    Description
    EEG power spectrum, ApEn approximate entropy, LZ complexity, RE, NR correlation
    Time Frame
    Change from 12 weeks EEG data at 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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