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Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons With Mild Cognitive Impairment

Dose-effect of Different Frequencies and Duration of Tai Chi Chuan to Improve Cognitive Function in Persons With Mild Cognitive Impairment

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06375720
Enrollment
350
Registered
2024-04-19
Start date
2024-05-05
Completion date
2025-12-15
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

Tai Chi Chuan, Cognitive Function

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.

Interventions

BEHAVIORALLower frequency, shorter period of Tai Chi Chuan

Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3 sessions/week for 12 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.

BEHAVIORALHigher frequency, shorter period of Tai Chi Chuan

Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 12 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.

BEHAVIORALLower frequency, longer period of Tai Chi Chuan

Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3 sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.

BEHAVIORALHigher frequency, longer period of Tai Chi Chuan

Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.

Participants would take standard health education 0.5 hour/ session, 2 sessions/month for 6 months.

Sponsors

Peking University Third Hospital
CollaboratorOTHER
Lidian Chen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Montreal Cognitive Assessment12 weeks, 24 weeksGlobal cognition

Secondary

MeasureTime frameDescription
Montreal Cognitive Assessment52 weeksGlobal cognition
Wechsler Memory Scale12 weeks, 24 weeks and 52 weeksMemory function
Digit Symbol Substitution Test12 weeks, 24 weeks and 52 weeksAttention
Trial Making Test part B12 weeks, 24 weeks and 52 weeksExecutive Function
Stroop Color Word Test12 weeks, 24 weeks and 52 weeksProcessing Speed
Boston Naming Test12 weeks, 24 weeks and 52 weeksVerbal fluency
Rey-Osterrieth Complex Graphics Test12 weeks, 24 weeks and 52 weeksVisuo-spatial ability
Rey Auditory Verbal Learning Test12 weeks, 24 weeks and 52 weeksEpisodic memory

Other

MeasureTime frameDescription
12-Item Short Form Health Survey12 weeks, 24 weeks and 52 weeksGeneral health
Blood glucose metabolism index12 weeks, 24 weeks and 52 weeksfasting blood glucose
Blood lipid metabolism index12 weeks, 24 weeks and 52 weekstotal cholesterol (TC); total triglyceride (TG); low density lipoprotein (LDL);high density lipoprotein (HDL)
functional Magnetic Resonance Imaging12 weeks or 24 weeks [post-intervention]functional Magnetic Resonance Imaging
Electroencephalogram12 weeks or 24 weeks [post-intervention]The power spectrum density of the brain in a relaxed state is measured using a resting-state electroencephalogram (EEG) for the delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-100 Hz) bands.
Heart rate variability12 weeks or 24 weeks [post-intervention]Cardiac autonomic modulations
Gut microflora12 weeks, 24 weeks and 52 weeks16S rRNA amplification sequencing was used to detect intestinal microbiota.
The Pittsburgh Sleep Quality Index (PSQI)12 weeks, 24 weeks and 52 weeksSleep quality

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026