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临床试验/NCT06372535
NCT06372535Unknown不适用

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

Lidian Chen0 个研究点目标入组 540 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
540
主要终点
Montreal Cognitive Assessment

研究概览

简要总结

To determine the impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Geriatric Depression Scale score ≥ 9 points
  • Cognitive impairment caused by other reasons, taking drugs, poisoning, etc;
  • 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;
  • Patients with severe heart, liver, kidney failure, malignant tumors, and other major diseases;
  • Individuals with visual/auditory impairments, writing/reading impairments, illiteracy, etc. that affect training and evaluation;
  • Individuals with uncontrolled hypertension (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg after medication);
  • Participating in other experiments that influence this study;
  • Engaged in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time.

结局指标

主要结局

Montreal Cognitive Assessment

时间窗: 8 weeks, 16 weeks, 24 weeks

Global cognition

次要结局

  • Montreal Cognitive Assessment(52 weeks)
  • Wechsler Memory Scale(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)
  • Trial Making Test part B(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)
  • 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)
  • Rey Auditory Verbal Learning 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)
  • Digital Symbol 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)
  • Stroop color word 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)
  • Boston naming 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)

研究者

发起方
Lidian Chen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lidian Chen

PhD

Fujian University of Traditional Chinese Medicine

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