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Intervention Effect of Yizhi Baduanjin on Patients With Mild Cognitive Impairment

S

Shanghai University of Traditional Chinese Medicine

Status

Not yet enrolling

Conditions

Mild Cognitive Impairment

Treatments

Other: Yizhi Baduanjin

Study type

Interventional

Funder types

Other

Identifiers

NCT05899777
ZY(2021-2023)-0105-B99

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

60 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Treatment group
Experimental group
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.
Treatment:
Other: Yizhi Baduanjin
control group
No Intervention group
Description:
The control group is a waiting control group, and after 24 weeks, they will continue to learn the Yizhi Baduanjin.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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