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【ChiCTR1900026857】Combining mind body physical exercise, cognitive training, and nurse-led risk factor modification to enhance cognition among older adults with mild cognitive impairment: a randomized controlled trial

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基本信息

登记号

ChiCTR1900026857

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2019-10-24

临床申请受理号

靶点

适应症

mild cognitive impairment

试验通俗题目

Combining mind body physical exercise, cognitive training, and nurse-led risk factor modification to enhance cognition among older adults with mild cognitive impairment: a randomized controlled trial

试验专业题目

Combining mind body physical exercise, cognitive training, and nurse-led risk factor modification to enhance cognition among older adults with mild cognitive impairment: a randomized controlled trial

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临床试验信息

试验目的

The aim of this study is to examine the effectiveness of a complex intervention: cognitive training, mind body physical exercise, and nurse-led risk factor modification (CPR) on reducing cognitive decline among the older adults aged between 60 and 80 years with MCI when compared to health advice (HA) in primary care.

试验分类

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

Computer-generated allocation sequencing will be done in blocks of eight in each intervention venue to ensure the balanced allocation of participants in each venue. This will be done by a statistician who is independent from the study.

盲法

The persons who conduct the assessments or data analyses will be blinded to group allocation.

试验项目经费来源

Health and Medical Research Fund (16170421)

试验范围

目标入组人数

152

实际入组人数

第一例入组时间

2019-11-01

试验终止时间

2024-11-01

是否属于一致性

入选标准

(1) aged between 60 years and 80 years; (2) having Montreal Cognitive Assessment Hong Kong version (HK-MoCA) score within 19-25 after adjusting for years of educational (+1 point if < 6 years) suggesting MCI according to published research; (3) being physically stable, as assessed by the study physician.；

排除标准

(1) a diagnosis of dementia; (2) concurrent treatment with structured cognitive training, regular physical exercises including Tai Chi or other lifestyle modifications (e.g., diet) although no restrictions will be imposed on leisure activity; (3) a past history of bipolar affective disorder or psychosis; (4) one or more significant communicative impairments. The use of psychotropic medication; this does NOT constitute an exclusion criterion, but any use of anti-dementia and other psychotropic medications should be kept on a stable dosage for at least three months before enrolment and also throughout the study.；

研究者信息

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试验机构

香港中文大學醫學院賽馬會公共衞生及基層醫療學院

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