Efficacy of Warmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions and Behavioral Symptoms in Older Adults with Dementia: a Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline
研究概览
简要总结
Evidence showed that both TENS and passive body heating are potential treatment strategies for improving cognitive functions in people with dementia. It is hypothesized that hat device (Warmth +TENS) over the 4 acupuncture points would induce a greater improvement in cognitive functions and behavioural symptoms when compared with other hat devices (Warmth + placebo-TENS; TENS only; Warmth alone) and Control (hat device with no warmth and no TENS).
详细描述
Acupuncture, a primary therapeutic method in traditional Chinese medicine, has been used for patients with dementia to improve memory, orientation, calculation, and self-managing ability in patients having dementia and prevent decline of cognitive functions. Results of animal studies have demonstrated that electroacupuncture on the head region is effective in managing the symptoms associated with dementia, including vascular dementia.
A review of 8 studies on effects of TENS on non-pain related cognitive and behavioural functioning in patients with Alzheimer's disease and non-demented patients concluded that TENS could improve memory, affective behaviour and rest-activity rhythm in patients having Alzheimer's disease.
Passive body heating is another novel physical intervention strategy which potentially can relieve the symptoms of dementia. A previous study demonstrated that the attention function of 15 elderly, measured by the reaction time in the Rapid Visual Processing Test, improved after passive body heating via a thermal suit. Moreover, 30 minutes of hot-water immersion improved the sleep quality in 13 people with vascular dementia.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are currently diagnosed having Alzheimer's disease, vascular dementia or mixed-type mild to major neurocognitive disorder based on the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM -5) by psychogeriatrician with more than 3 years of experience in dementia diagnosis;
- •are categorized in the mild or moderate degree of dementia based on the Global Deterioration Scale;
- •have a stable drug intake for the past 3 months;
- •live with at least 1 caregiver in the community;
- •are able to follow simple instructions;
- •are able to give informed consent by them or their family members.
排除标准
- •have unstable medical conditions or severe behavioural disturbances, which do not allow participation in the study as judged by the study psychogeriatrician,
- •have any additional medical, cardiovascular , orthopedic or cognitive conditions, such as having uncontrolled hypertension unstable angina and comorbid schizophrenia, that would hinder proper assessment and treatment.
- •use a cardiac pacemaker,
- •live in old age home, elderly home or care and attention homes,
- •receive long term nursing home placements of patients during the treatment phase
结局指标
主要结局
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline
时间窗: Baseline (0 week)
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - post intervention
时间窗: 6 weeks
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - short term followup
时间窗: 10 weeks
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - long term followup
时间窗: 62 weeks
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
次要结局
- Chinese version of Disability Assessment for Dementia (C-DAD) - long term followup(62 weeks)
- Chinese version of Disability Assessment for Dementia (C-DAD) - baseline(baseline (0 week))
- Chinese version of Disability Assessment for Dementia (C-DAD) - post intervention(6 weeks)
- Chinese version of Disability Assessment for Dementia (C-DAD) - short term followup(10 weeks)
- Pittsburg Sleep Quality Index (PSQI) - post intervention(6 weeks)
- Pittsburg Sleep Quality Index (PSQI) - baseline(baseline (0 weeks))
- Pittsburg Sleep Quality Index (PSQI) - short term followup(10 weeks)
- Pittsburg Sleep Quality Index (PSQI) - long term followup(62 weeks)
研究者
Shamay Ng
Associate Professor
The Hong Kong Polytechnic University