The Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia and With Hypertension (CONTENT-Hypertension): a Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
Objective A growing body of evidence supports hypertension as a risk factor for cognitive decline. Hypertension is significantly associated with accelerated cognitive decline, poorer cognitive function, and mild cognitive impairment and dementia. Cognitive training is an effective intervention to improve cognitive function. However, the current cognitive training does not fully consider the different areas and degrees of cognitive function impairmentof older adults. This study aims to evaluate the effect of adaptive cognitive training on cognitive function of older adults with hypertension in the community.
Participants aged 60 years or older, diagnosis of hypertension, and cognitive function assessment showed no dementia.
Design The study was designed as a double-blind randomized controlled trial. 120 hypertension participants without dementia aged 60 years or older in Shijingshan and Haidian, Beijing were included. Participants will be randomized to adaptive cognitive training (intervention group) and placebo cognitive training (control group) at a ratio of 1:1. Both training will be delivered by using PADs with the same appearance. The interventions will last for 12 weeks and follow up to 24 weeks, and both groups will be followed up on the same time schedules for all outcome measurements. The primary outcome is changes in MoCA scores from baseline to the end of the 12-week intervention.
The current trial has been reviewed by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (approval number: 2024-162).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •(1) Could not complete neuropsychological tests; (2) Suffering other disease or medication use might affect cognitive function, such as a new stroke within 6 months before baseline or use tranquilizers; (3) Unable to use PADs or unable to complete the training; (4) Unacceptable or refuse to participate in cognitive training; (5) Living in the same family with a subject who has been randomly assigned.
排除标准
- 未提供
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: baseline; "post-intervention, 12 weeks"
MoCA has been widely used in the cognitive function assessment of middle-aged and elderly people in China, including executive function, memory, orientation, computation, conceptual thinking, visual perception, language, attention and attention. The MoCA scale scores ranged from 0 to 30, and the lower the score, the worse the cognitive function.
次要结局
- Montreal Cognitive Assessment (MoCA)(baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up)
- the Trail Making Test (TMT)(baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up)
- the Digit Symbol Substitution Test (DSST)(baseline; 6 week-intervention; post-intervention, 12 weeks; 24 weeks follow-up)
- the WHO-UCLA Auditory Verbal Learning Test(AVLT)(baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up)
- the Boston Naming Test (BNT)(baseline; 6 week-intervetion; "post-intervention, 12 weeks"; 24 weeks follow-up)
- Geriatric Depression Scale (GDS)(baseline; 6 week-intervention; "post-intervention, 12 weeks")
- Generalized Anxiety Disorder-7 (GAD-7)(baseline; 6 week-intervention; "post-intervention, 12 weeks")
- Pittsburgh sleep quality index (PSQI)(baseline; 6 week-intervention; "post-intervention, 12 weeks")
- Blood pressure(baseline; "post-intervention, 12 weeks")
研究者
Wuxiang Xie
Researcher, Associate professor
Peking University