Clinical trial NCT06372535: Effects of Tai Chi Chuan With Different Doses on Cognitive Function in Elderly Patients With Mild Cognitive Impairment
Official title: Dose-Response Effects of Tai Chi Chuan Interventions on Cognitive Function in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Tai Chi Chuan
Cognitive Function
Dose-response
Lead sponsor: Fujian University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
First posted: 2024-04-18
Enrollment: 540
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 impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment.

Detailed 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.

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 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: 8 weeks, 16 weeks, 24 weeks
Secondary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: 52 weeks
measure: Wechsler Memory Scale
timeFrame: 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
measure: Digital Symbol test
timeFrame: 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
measure: Trial Making Test part B
timeFrame: 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
measure: Stroop color word test
timeFrame: 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
measure: Boston naming test
timeFrame: 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
measure: Rey-Osterrieth complex graphics test
timeFrame: 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
measure: Rey Auditory Verbal Learning Test
timeFrame: 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
Other outcomes:
measure: Blood glucose metabolism index
timeFrame: 8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
measure: Blood lipid metabolism index
timeFrame: 8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
measure: Functional Magnetic Resonance Imaging
timeFrame: 8 weeks or 16 weeks or 24 weeks [post-intervention]
measure: Electroencephalogram
timeFrame: 8 weeks or 16 weeks or 24 weeks [post-intervention]
measure: Heart rate variability
timeFrame: 8 weeks or 16 weeks or 24 weeks [post-intervention]
measure: Gut microflora
timeFrame: 8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
measure: Sleep Quality
timeFrame: 8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
measure: General health
timeFrame: 8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
Locations:
Study officials:
References: