Mild Cognitive ImpairmentNCT05899777
Intervention Effect of Yizhi Baduanjin on Patients With Mild Cognitive Impairment
A study testing Yizhi Baduanjin in people with Mild Cognitive Impairment, run by Shanghai University of Traditional Chinese Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Yizhi Baduanjin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Dec 2023
- 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
- 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
Who cannot join
- 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
About this study
Official title: Research, Development and Promotion of the Service Package of Yizhi Baduanjin for Mild Cognitive Impairment
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Yizhi Baduanjin
- Keywords
- Mild Cognitive Impairment, Baduanjin
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yizhi BaduanjinOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from 12 weeks MOCA at 24 weeks
Secondary outcomes (6)
Cognitive Function Score
Objective scores for the four cognitive tasks of "positional circle", "numerical circle", "numerical string", and "operation" in the MCI screening tool.
Measured: Change from Baseline cognitive function score at 4 weeks
Cognitive Function Score
Objective scores for the four cognitive tasks of "positional circle", "numerical circle", "numerical string", and "operation" in the MCI screening tool.
Measured: Change from 4 weeks cognitive function score at 12 weeks
Cognitive Function Score
Objective scores for the four cognitive tasks of "positional circle", "numerical circle", "numerical string", and "operation" in the MCI screening tool.
Measured: Change from 12 weeks cognitive function score at 24 weeks
EEG data
EEG power spectrum, ApEn approximate entropy, LZ complexity, RE, NR correlation
Measured: Change from Baseline EEG data at 4 weeks
EEG data
EEG power spectrum, ApEn approximate entropy, LZ complexity, RE, NR correlation
Measured: Change from 4 weeks EEG data at 12 weeks
EEG data
EEG power spectrum, ApEn approximate entropy, LZ complexity, RE, NR correlation
Measured: Change from 12 weeks EEG data at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899777
- Sponsor's protocol ID
- ZY(2021-2023)-0105-B99
- Status last verified
- Feb 2023
- First submitted
- 17 Apr 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research, Development and Promotion of the Service Package of Yizhi Baduanjin for Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05899777
- Acronym / sponsor ID
- ZY(2021-2023)-0105-B99
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Baduanjin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Yizhi BaduanjinAfter 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. |
| control group | No intervention | –The control group is a waiting control group, and after 24 weeks, they will continue to learn the Yizhi Baduanjin. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yizhi BaduanjinYizhi 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. | Other | Treatment group |
Primary outcome
MoCA
Time frame: Change from Baseline MOCA at 4 weeks
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
Time frame: Change from 4 weeks MOCA at 12 weeks
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
Time frame: Change from 12 weeks MOCA at 24 weeks
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.
6 secondary outcomes
Cognitive Function Score
Time frame: Change from Baseline cognitive function score at 4 weeks
Cognitive Function Score
Time frame: Change from 4 weeks cognitive function score at 12 weeks
Cognitive Function Score
Time frame: Change from 12 weeks cognitive function score at 24 weeks
EEG data
Time frame: Change from Baseline EEG data at 4 weeks
EEG data
Time frame: Change from 4 weeks EEG data at 12 weeks
EEG data
Time frame: Change from 12 weeks EEG data at 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Yizhi Baduanjin in people with Mild Cognitive Impairment, run by Shanghai University of Traditional Chinese Medicine.
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 4 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
MoCA (time frame: Change from Baseline MOCA at 4 weeks). The study lists 3 primary outcomes in all. 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 12 Jun 2023.