Clinical trial NCT06375720: Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons With Mild Cognitive Impairment
Official title: Dose-effect of Different Frequencies and Duration of Tai Chi Chuan to Improve Cognitive Function in Persons With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Tai Chi Chuan
Cognitive Function
Lead sponsor: Fujian University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
First posted: 2024-04-19
Enrollment: 350
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment.

Detailed description: Mild cognitive impairment (MCI) is regarded as a prodrome to dementia and affects 16% to 20% of people aged older than 65 years. Tai Chi Chuan is an increasingly popular multi-modal physical and mental exercise. Studies have shown that Tai Chi Chuan can effectively improve the cognitive function of elderly persons with MCI. However, the relationship between the effects of different frequencies and duration of Tai Chi Chuan to improve the cognitive function of elderly persons with MCI is not yet clear. The purpose of this study is to determine the optimal frequency and duration of Tai Chi Chuan. The investigators will conduct a single-blind, randomized controlled trial in 350 persons who meet the presence of MCI without dementia. Persons will be randomly assigned to either the Tai Chi Chuan intervention group once or twice a week for 12 or 24 weeks, or the health education control group once every four weeks for 24 weeks. All groups will be followed for 52 weeks.

Eligibility criteria: Inclusion Criteria:

1. Presence of mild cognitive impairment, not demented;
2. Age ≥ 60 years old;
3. Informed consent and voluntary participation.

Exclusion Criteria:

1. Geriatric Depression Scale score ≥ 9 points;
2. Cognitive impairment caused by other reasons, taking drugs, poisoning, etc;
3. Suffer from severe musculoskeletal system diseases and other contraindications to exercise and are not suitable for Tai Chi Chuan training, such as those who suffer from stroke, Parkinson's disease, and have a history of lower limb arthritis, hip and knee joint replacement, etc;
4. Patients with severe heart, liver, kidney failure, malignant tumors, and other major diseases;
5. Individuals with visual/auditory impairments, writing/reading impairments, illiteracy, etc. that affect training and evaluation;
6. Individuals with uncontrolled hypertension (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg after medication);
7. Participating in other experiments that influence this study;
8. Engaged in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time).

Primary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: 12 weeks, 24 weeks
Secondary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: 52 weeks
measure: Wechsler Memory Scale
timeFrame: 12 weeks, 24 weeks and 52 weeks
measure: Digit Symbol Substitution Test
timeFrame: 12 weeks, 24 weeks and 52 weeks
measure: Trial Making Test part B
timeFrame: 12 weeks, 24 weeks and 52 weeks
measure: Stroop Color Word Test
timeFrame: 12 weeks, 24 weeks and 52 weeks
measure: Boston Naming Test
timeFrame: 12 weeks, 24 weeks and 52 weeks
measure: Rey-Osterrieth Complex Graphics Test
timeFrame: 12 weeks, 24 weeks and 52 weeks
measure: Rey Auditory Verbal Learning Test
timeFrame: 12 weeks, 24 weeks and 52 weeks
Other outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 weeks, 24 weeks and 52 weeks
measure: 12-Item Short Form Health Survey
timeFrame: 12 weeks, 24 weeks and 52 weeks
measure: Blood glucose metabolism index
timeFrame: 12 weeks, 24 weeks and 52 weeks
measure: Blood lipid metabolism index
timeFrame: 12 weeks, 24 weeks and 52 weeks
measure: functional Magnetic Resonance Imaging
timeFrame: 12 weeks or 24 weeks [post-intervention]
measure: Electroencephalogram
timeFrame: 12 weeks or 24 weeks [post-intervention]
measure: Heart rate variability
timeFrame: 12 weeks or 24 weeks [post-intervention]
measure: Gut microflora
timeFrame: 12 weeks, 24 weeks and 52 weeks
Locations:
Study officials:
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