跳至主要内容
临床试验/NCT05540613
NCT05540613招募中不适用

Tai Chi Versus Conventional Exercise to Improve Cognitive Performance in Older Adults With Mild Cognitive Impairment (MCI): A Comparative Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
315
试验地点
1
主要终点
The score of the Montreal Cognitive Assessment (MoCA)

研究概览

简要总结

This randomized controlled trial aims to evaluate the effectiveness of Tai Chi and conventional exercise on improving cognitive function in older adults with mild cognitive impairment (MCI). Participants will be randomized into three six-month programmes, namely Health Education group, Tai Chi group and Conventional Exercise group. Assessments will be conducted at baseline, after the 26-week interventions, and 26-week after the competition of the intervention.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Chinese older adults aged equal or larger than 50 years
  • •Ethnic Chinese
  • •MCI under criteria of Mayo Clinic, including the following
  • •i. people with subjective complaint about a decline in cognitive function. ii. total score in the Montreal Cognitive Assessment is equal or below the 7th percentile of the age- and education- corrected normative data of Hong Kong. iii. the decline in cognitive function does not impair daily functioning, as revealed by getting ≥2 marks in every item on the Chinese Lawton Instrumental Activities of Daily Living 4-point Scale).

排除标准

  • •medical history of major chronic diseases such as cancer, stroke, cerebro- and cardio-vascular diseases, and renal disease
  • •uncontrolled diabetes
  • •diagnosed with dementia or using anti-dementia medication
  • •diagnosed with psychiatric diseases or using psychiatric medication
  • •with diseases or on medications known to severely affect cognitive performance
  • •somatic condition (e.g., limb lost) that prevent participation in exercise
  • •impaired mobility by chronic diseases (e.g., neurological, musculoskeletal and autoimmune diseases)
  • •incapable to perform physical exercise
  • •regular exercise habit (>3 times 60-min Tai Chi or moderate-intensity conventional exercise weekly) in the past 3 months

研究组 & 干预措施

Health Education

Sham Comparator

A 26 weeks brain health and general health education program with two 1.5-hour sessions weekly.

干预措施: Health Education (Behavioral)

Conventional Exercise

Active Comparator

A 26 weeks Conventional Exercise training with two 1.5-hour sessions weekly.

干预措施: Conventional Exercise (Behavioral)

Tai Chi

Experimental

A 26 weeks Tai Chi training with two 1.5-hour sessions weekly.

干预措施: Tai Chi (Behavioral)

结局指标

主要结局

The score of the Montreal Cognitive Assessment (MoCA)

时间窗: 52 weeks

Change in the score of the Montreal Cognitive Assessment. The score ranged from 0 to 30. Higher score indicates a better cognitive function. Participants scoring equal or below the 7th percentile of the age- and education-corrected normative data will be considered as having MCI.

The score of the Montreal Cognitive Assessment (MoCA)

时间窗: 26 weeks

Change in the score of the Montreal Cognitive Assessment. The score ranged from 0 to 30. Higher score indicates a better cognitive function. Participants scoring equal or below the 7th percentile of the age- and education-corrected normative data will be considered as having MCI.

次要结局

  • Clinical Dementia Rating(26 weeks and 52 weeks)
  • Neurocognitive Test(26 weeks and 52 weeks)
  • The 12-Item Short Form Survey(26 weeks and 52 weeks)
  • Subjective Cognitive Performance(26 weeks and 52 weeks)
  • Medication Use(26 weeks and 52 weeks)
  • Short Physical Performance Battery (SPPB) Test(26 weeks and 52 weeks)
  • Habitual Physical Activity(26 weeks and 52 weeks)
  • Subjective Memory complaints(26 weeks and 52 weeks)
  • The Hospital Anxiety and Depression Scale(26 weeks and 52 weeks)
  • Subjective Sleep Quality(26 weeks and 52 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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