Clinical trial NCT05899777: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Baduanjin
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MoCA
timeFrame: Change from Baseline MOCA at 4 weeks
measure: MoCA
timeFrame: Change from 4 weeks MOCA at 12 weeks
measure: MoCA
timeFrame: Change from 12 weeks MOCA at 24 weeks
Secondary outcomes:
measure: Cognitive Function Score
timeFrame: Change from Baseline cognitive function score at 4 weeks
measure: Cognitive Function Score
timeFrame: Change from 4 weeks cognitive function score at 12 weeks
measure: Cognitive Function Score
timeFrame: Change from 12 weeks cognitive function score at 24 weeks
measure: EEG data
timeFrame: Change from Baseline EEG data at 4 weeks
measure: EEG data
timeFrame: Change from 4 weeks EEG data at 12 weeks
measure: EEG data
timeFrame: Change from 12 weeks EEG data at 24 weeks
Other outcomes:
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