跳至主要内容
临床试验/NCT04305951
NCT04305951已完成不适用

Combining Acupuncture and Acupressure for Dementia Elderly: an Assessor-blinded, Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2021年10月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
236
试验地点
1
主要终点
Changes in the Montreal Cognitive Assessment Score

研究概览

简要总结

This is an assessor-blinded, randomized controlled trial. A total of 248 (anticipated) elderly people aged ≥65 years with a mild to moderate dementia will be recruited from local nursing and care homes. They will be randomly assigned to routine care, CAT, CAE, and CAT+CAE with n = 62 subjects in each group. Subjects assigned to CAT, CAE, and CAT+CAE will respectively receive 2 sessions of CAT, 3 sessions of CAE, and a combination of both per week for 12 weeks. The primary outcome is the baseline-to-endpoint change in score of the Montreal Cognitive Assessment (MoCA). Secondary outcomes include various domains of MoCA, functional independence, psychological well-being, sleep quality, and level of pain. A generalized linear mixed-effect model will be used to compare outcomes over time among the four groups.

详细描述

Currently, there are about 100,000 people aged 65 years and older who are suffering from clinically diagnosed dementia in Hong Kong (HK). With an ageing population, this number will increase to 280,000 by 2036. Most dementia elderly live in nursing homes and elderly daycare centers. Dementia is the major cause of disability and dependency in elderly people. It poses a significant burden on caregivers, families, and the public healthcare system. Patients with dementia not only have a wide range of cognitive impairment, but also develop a variety of frailty-related symptoms, mainly including physical and psychological frailty, such as musculoskeletal deterioration, neurological disorders, sleep, emotional, and even psychotic symptoms. The overall purpose of the management of dementia elderly is to reduce dementia- and frailty-caused adverse outcomes that increase disability, dependency, hospitalization, and long-term care admission. However, there is a dearth of effective interventions improving the quality of life of elderly with dementia. The development of holistic management strategies that not only prevent and slow cognitive deterioration, but also reduce various other symptoms is therefore highly desired.

Acupuncture has been widely used in the local clinical practice. Numerous studies have shown the benefits of acupuncture in reducing cognitive deterioration in patients with cognitive impairment and dementia and animal models. Acupuncture is also effective in improving physical disability, rigidity, gait, and postural balance in aging adults with stroke and Parkinson's disease. A large body of evidence further confirms the effectiveness of various acupuncture regimens in treating pain, fatigue, sleep disturbance, anxiety, and depression. On the other hand, it is well demonstrated that, as a convenient therapy, acupressure has particular benefits in alleviating sleep disturbance, anxiety, depression, and agitation in elderly with dementia. Acupressure also has positive effects on the recovery of motor function and daily activities of stroke patients. These studies suggest that acupuncture and acupressure could produce benefits for the elderly with dementia.

Most recently, we have completed three clinical trials that evaluated the efficacy of acupuncture treatment of vascular dementia; stroke-caused cognitive deterioration , and chemotherapy-induced cognitive impairment. All these trials have consistently revealed that acupuncture was effective in alleviating cognitive impairment. We also have shown the effectiveness of a caregiver-performed acupressure on the general quality of life in frail older people and self-administered acupressure for insomnia disorder. The caregiver-performed acupressure protocol is called 'Comfy Acupressure for the Elderly (CAE)' and demonstration video is accessible at https://www.youtube.com/watch?v=pAqNIZPKmnM. Furthermore, our several studies have confirmed the efficacy of acupuncture in improving major depression ; insomnia and anxiety, poststroke depression and movement disability. Meanwhile, we have developed a novel acupuncture mode called comprehensive acupuncture therapy (CAT) that consists of dense frontal acupoints with additional electrical stimulation and multiple body acupoints. The efficacy of CAT has been well proven in our previous studies.

The working hypothesis is that CAT and CAE are feasible, safe, and could produce better management outcomes than routine care in improving cognitive impairment, frailty-related disability and dependency as well as comorbid symptoms of aged people with dementia. The aims of this study are: (1) to determine whether the conditions of cognitive impairment in the treatment groups improve significantly when compared to control; (2) to determine whether other symptoms (e.g., functional independence, pain, depression, and sleep disorder) in the treatment groups improve more than in control; and (3) to investigate whether acupuncture or acupressure is safe for the elderly with cognitive impairment or 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
Single (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

入选标准

  • have a clinical diagnosis of any type of dementia or met the criteria of major and mild neurocognitive disorder based on the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and
  • have mild to moderate dementia at a stage of 3-5 on the Global Deterioration Scale (GDS).

排除标准

  • have of dementia with the stage below 3 or above 5 on the GDS;
  • have severe skin lesions on acupuncture and acupressure areas;
  • have significant bleeding tendency;
  • have heart pacemaker or implantable cardioverter defibrillator;
  • are currently receiving acupressure as a regular therapy;
  • had a surgery on the head or neck;
  • are currently receiving anti-coagulant treatment.

研究组 & 干预措施

Routine care group

No Intervention

Subjects assigned to this group will continue their routine care without receiving any acupuncture and acupressure treatment during the study period. The routine care may include physiotherapy and intellectual activities. Post-trial treatment of either CAT, CAE, or CAT+CAE will be offered to serve as a compensation for their participation.

CAT group

Experimental

Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.

干预措施: Comprehensive acupuncture therapy (CAT) (Procedure)

CAE group

Experimental

Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.

干预措施: Comfy Acupressure for the Elderly (CAE) (Procedure)

CAT + CAE group

Experimental

Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.

干预措施: Comprehensive acupuncture therapy (CAT) (Procedure)

CAT + CAE group

Experimental

Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.

干预措施: Comfy Acupressure for the Elderly (CAE) (Procedure)

结局指标

主要结局

Changes in the Montreal Cognitive Assessment Score

时间窗: Baseline, 6 week, 12 week

Severity of dementia is primarily measured using Montreal Cognitive Assessment (MoCA) and its overall score ranges from 0 to 30. A higher score indicates better cognition. Assessments will be conducted at baseline and once every six weeks thereafter.

次要结局

  • Change in the Digit Span Forward(Baseline, 6 week, 12 week)
  • Change in the Digit Span Reverse(Baseline, 6 week, 12 week)
  • Changes in the Modified Bathel Index Score(Baseline, 6 week, 12 week)
  • Changes in the Visual Analogue Scale Score(Baseline, 6 week, 12 week)
  • Changes in the Geriatric Depression Scale Score(Baseline, 6 week, 12 week)
  • Changes in the Insomnia Severity Index Score(Baseline, 6 week, 12 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Zhang Zhang-Jin

Professor, Associate Director (Clinical Affairs)

The University of Hong Kong

研究点 (1)

Loading locations...

相似试验