ChiCTR1900026857已完成Unknown
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
Health and Medical Research Fund (16170421)1 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2019年11月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- The Chinese version of the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- The persons who conduct the assessments or data analyses will be blinded to group allocation.
入排标准
- 年龄范围
- 60 至 80（—）
- 性别
- All
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.
研究组 & 干预措施
1
cognitive training, mind body physical exercise, and nurse-led risk factor modification (CPR)
2
risk factor modification (RFM)
3
health advice control (HA)
结局指标
主要结局
The Chinese version of the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog)
时间窗: at baseline, 6, 12 and 15 months post baseline
次要结局
- Common diseases(at baseline, 6, 12 and 15 months post baseline)
- CDR sum of box(at baseline, 6, 12 and 15 months post baseline)
- The Disability Assessment for Dementia (DAD)(at baseline, 6, 12 and 15 months post baseline)
- Quality of life (EQ5D)(at baseline, 6, 12 and 15 months post baseline)
- Depression and anxiety(at baseline, 6, 12 and 15 months post baseline)
- Cigarette smoking, alcohol drinking, diet and physical exercise(at baseline, 6, 12 and 15 months post baseline)
- Health service utilization(at baseline, 6, 12 and 15 months post baseline)
- Demographic data(at baseline)
研究者
研究点 (1)
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