Intervention Effect of Yizhi Baduanjin on Patients With Mild Cognitive Impairment

NCT ID: NCT05899777

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2023-12-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group

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.

Group Type: EXPERIMENTAL

Yizhi Baduanjin

Intervention Type: 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.

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Yizhi Baduanjin

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ZY(2021-2023)-0105-B99

Identifier Type: -

Identifier Source: org_study_id