Effects of Tai Chi Chuan With Different Doses on Cognitive Function in Elderly Patients With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Dose-Response Effects of Tai Chi Chuan Interventions on Cognitive Function in Mild Cognitive Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06372535
• Other study ID #: FujianUTCM-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 30, 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 impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment.

Description:

Taking MCI as a potential gateway, early intervention to delay the occurrence of dementia has become an important consensus in this field. Exercise is an important means to improve cognitive function in MCI, but the effect of exercise is influenced by the dosage. Tai Chi Chuan, is a moderate intensity aerobic exercise. Previous studies by our team and others had confirmed its effect on cognitive function in MCI. However, the dose parameters of Tai Chi Chuan exercise varied in these studies, and the dose-response relationship is still unclear. The purpose of this study is to explore the dose-response relationship between different volume of Tai Chi Chuan exercise and cognitive function（global cognition and cognition of subdomains）in elderly MCI patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 540
• Est. completion date: September 30, 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 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:
• Tai Chi Chuan (dose 1)
Participants would take 24-form simplified Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 8 weeks. There were 10 minutes warm-up, 30 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.
• Tai Chi Chuan (dose 2)
Participants would take 24-form simplified Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 16 weeks. There were 10 minutes warm-up, 30 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.
• Tai Chi Chuan (dose 3)
Participants would take 24-form simplified Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 24 weeks. There were 10 minutes warm-up, 30 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.
• Tai Chi Chuan (dose 4)
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 8 weeks. There were 10 minutes warm-up, 60 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.
• Tai Chi Chuan (dose 5)
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 16 weeks. There were 10 minutes warm-up, 60 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.
• Tai Chi Chuan (dose 6)
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks. There were 10 minutes warm-up, 60 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.
• Tai Chi Chuan (dose 7)
Participants would take 24-form simplified Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 8 weeks. There were 10 minutes warm-up, 90 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.
• Tai Chi Chuan (dose 8)
Participants would take 24-form simplified Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 16 weeks. There were 10 minutes warm-up, 90 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.
• Tai Chi Chuan (dose 9)
Participants would take 24-form simplified Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 24 weeks. There were 10 minutes warm-up, 90 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.

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	Blood glucose metabolism index	fasting blood glucose	8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
Other	Blood lipid metabolism index	total cholesterol (TC), total triglyceride (TG), low density lipoprotein (LDL), high density lipoprotein (HDL)	8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
Other	Functional Magnetic Resonance Imaging	Functional Magnetic Resonance Imaging	8 weeks or 16 weeks or 24 weeks [post-intervention]
Other	Electroencephalogram	Resting-State Electroencephalogram (EEG) Power Spectrum Changes. 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. Changes in the power of these frequency bands before and after the intervention are assessed to reflect changes in the level of brain activity.; Task-Related Brain Electrophysiological Activity While performing specific cognitive tasks, brain activity is recorded using an Electroencephalogram (EEG), and task-related EEG event-related potentials are analyzed.	8 weeks or 16 weeks or 24 weeks [post-intervention]
Other	Heart rate variability	cardiac autonomic modulations	8 weeks or 16 weeks or 24 weeks [post-intervention]
Other	Gut microflora	16S rRNA amplification sequencing will be used to detect intestinal microbiota. Stool sample from each sub center will be stored within 1 h of collection at - 80 °C freezer. Subsequently, the fecal samples will be stored in dry ice and transported in batches to the laboratory within 8 hours, followed by storage in - 80 °C freezer.	8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
Other	Sleep Quality	The Pittsburgh Sleep Quality Index will be used to evaluate sleep quality, with a total score of 0-21. The higher the score, the poorer the sleep quality.	8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
Other	General health	12-Item Short Form Health Survey will be used to evaluate general health. the higher the total score, the better the individual's health status.	8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
Primary	Montreal Cognitive Assessment	Global cognition	8 weeks, 16 weeks, 24 weeks
Secondary	Montreal Cognitive Assessment	Global cognition	52 weeks
Secondary	Wechsler Memory Scale	Memory function	8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks
Secondary	Digital Symbol test	Attention	8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks
Secondary	Trial Making Test part B	Executive function	8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks
Secondary	Stroop color word test	Processing speed	8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks
Secondary	Boston naming test	Verbal fluency	8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks
Secondary	Rey-Osterrieth complex graphics test	Rey-Osterrieth complex graphics test	8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks
Secondary	Rey Auditory Verbal Learning Test	Episodic memory	8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks