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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375720
• Other study ID #: FujianUTCM-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 5, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: April 2024
• Source: Fujian University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Lower 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.
• Higher 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.
• Lower 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.
• Higher 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.
• Standard Health Education
Participants would take standard health education 0.5 hour/ session, 2 sessions/month for 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lidian Chen	Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Pittsburgh Sleep Quality Index (PSQI)	Sleep quality	12 weeks, 24 weeks and 52 weeks
Other	12-Item Short Form Health Survey	General health	12 weeks, 24 weeks and 52 weeks
Other	Blood glucose metabolism index	fasting blood glucose	12 weeks, 24 weeks and 52 weeks
Other	Blood lipid metabolism index	total cholesterol (TC); total triglyceride (TG); low density lipoprotein (LDL);high density lipoprotein (HDL)	12 weeks, 24 weeks and 52 weeks
Other	functional Magnetic Resonance Imaging	functional Magnetic Resonance Imaging	12 weeks or 24 weeks [post-intervention]
Other	Electroencephalogram	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.	12 weeks or 24 weeks [post-intervention]
Other	Heart rate variability	Cardiac autonomic modulations	12 weeks or 24 weeks [post-intervention]
Other	Gut microflora	16S rRNA amplification sequencing was used to detect intestinal microbiota.	12 weeks, 24 weeks and 52 weeks
Primary	Montreal Cognitive Assessment	Global cognition	12 weeks, 24 weeks
Secondary	Montreal Cognitive Assessment	Global cognition	52 weeks
Secondary	Wechsler Memory Scale	Memory function	12 weeks, 24 weeks and 52 weeks
Secondary	Digit Symbol Substitution Test	Attention	12 weeks, 24 weeks and 52 weeks
Secondary	Trial Making Test part B	Executive Function	12 weeks, 24 weeks and 52 weeks
Secondary	Stroop Color Word Test	Processing Speed	12 weeks, 24 weeks and 52 weeks
Secondary	Boston Naming Test	Verbal fluency	12 weeks, 24 weeks and 52 weeks
Secondary	Rey-Osterrieth Complex Graphics Test	Visuo-spatial ability	12 weeks, 24 weeks and 52 weeks
Secondary	Rey Auditory Verbal Learning Test	Episodic memory	12 weeks, 24 weeks and 52 weeks