Combining Acupuncture and Acupressure for Community-dwelling Elderly With Dementia

Study Overview
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Brief Summary
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This is an assessor-blinded, randomized controlled trial. A total of 248 community-dwelling elderly people aged ≥65 years with a mid-mild to moderate dementia will be recruited from confirmed local 24 nursing and care homes. They will be randomly assigned to routine care, CAT, CAE, and CAT+CAE with n = 62 subjects 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 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.

Detailed Description
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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 community dwellings, such as nursing homes and elderly day care 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, including progressive memory loss, increasing difficulty in communication and language, concentration and attention, reasoning and judgment, 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 community-dwelling 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 community dwelling 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 a combination of acupuncture and acupressure could produce greater and broader 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. These studies have led us to hypothesize that CAT, CAE, and a combination of both as a holistic intervention could produce additive and even synergistic effects than routine care in improving cognitive impairment, frailty-related disability and dependency as well as comorbid symptoms in aged people with dementia. The working hypothesis is that CAT, CAE, and a combination of both (CAT+CAE) could produce better management outcomes than routine care in improving cognitive impairment, frailty-related disability and dependency as well as comorbid symptoms of community-dwelling aged people with dementia. To test this hypothesis, an assessor-blinded, randomized controlled trial will be conducted to examine whether CAT+CAE could produce greater and broader improvement than routine care and even than CAT and CAE alone in improving cognitive deterioration and comorbid symptoms in community-dwelling elderly with dementia.

Official Title
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Combining Acupuncture and Acupressure for Community-dwelling Elderly With Dementia: an Assessor-blinded, Randomized Controlled Trial

Conditions
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Dementia

Intervention / Treatment
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* Procedure: Comprehensive acupuncture therapy (CAT) (Hwato®/ Dongbang®)
* Procedure: Comfy Acupressure for the Elderly (CAE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine care group<br>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. | |
| Active Comparator: CAT group<br>Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care. | Procedure: Comprehensive acupuncture therapy (CAT) (Hwato®/ Dongbang®)<br>* CAT will be conducted for 2 sessions per week for 12 consecutive weeks. The following 15 body acupoints with only manual stimulation will be used: Shen-Men (HT7), He-Gu (LI4), Wai-Guan (TE5), Zu-San-Li (ST36), Feng-Long (ST40) and San-Yin-Jiao (SP6) in two sides, and Zhong-Wan (CV12), Guan-Yuan (CV4), and Shui-Gou (GV26) in midline. Electrical stimulation will be conducted on six pairs of frontal acupoints located on the frontal, parietal, and temporal scalp areas. Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) will be inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation will be carried out for all acupoints to evoke needling sensation. Electrical stimulation is additionally delivered on the 6 pairs of the frontal acupoints. Each session of treatment will last 30 min.<br>|
| Active Comparator: CAE group<br>Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care. | Procedure: Comfy Acupressure for the Elderly (CAE)<br>* CAE intervention will be conducted for 3 times per week for 12 consecutive weeks. CAE consists of 12 steps which need about 15 min to complete and mainly concentrates on the acupoints on face, head, neck, and shoulder. The detailed CAE Operation Guide will be provided for the provider and the video demonstration is accessible at https://www.youtube.com/watch?v=pAqNIZPKmnM.<br>|
| Active Comparator: CAT + CAE group<br>Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care. | Procedure: Comprehensive acupuncture therapy (CAT) (Hwato®/ Dongbang®)<br>* CAT will be conducted for 2 sessions per week for 12 consecutive weeks. The following 15 body acupoints with only manual stimulation will be used: Shen-Men (HT7), He-Gu (LI4), Wai-Guan (TE5), Zu-San-Li (ST36), Feng-Long (ST40) and San-Yin-Jiao (SP6) in two sides, and Zhong-Wan (CV12), Guan-Yuan (CV4), and Shui-Gou (GV26) in midline. Electrical stimulation will be conducted on six pairs of frontal acupoints located on the frontal, parietal, and temporal scalp areas. Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) will be inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation will be carried out for all acupoints to evoke needling sensation. Electrical stimulation is additionally delivered on the 6 pairs of the frontal acupoints. Each session of treatment will last 30 min.<br>Procedure: Comfy Acupressure for the Elderly (CAE)<br>* CAE intervention will be conducted for 3 times per week for 12 consecutive weeks. CAE consists of 12 steps which need about 15 min to complete and mainly concentrates on the acupoints on face, head, neck, and shoulder. The detailed CAE Operation Guide will be provided for the provider and the video demonstration is accessible at https://www.youtube.com/watch?v=pAqNIZPKmnM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Montreal Cognitive Assessment (MoCA) | Severity of dementia is primarily measured using Montreal Cognitive Assessment (MoCA). Assessments will be conducted at baseline and once every six weeks thereafter. | Baseline, 6 week, 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Digit span test | Attentional function and working memory is measured using Digit span test. Assessments will be conducted at baseline and once every six weeks thereafter. | Baseline, 6 week, 12 week | 
| Changes in Bathel Index (BI) | Functional independence is measured using Bathel Index (BI). Assessments will be conducted at baseline and once every six weeks thereafter. | Baseline, 6 week, 12 week | 
| Changes in visual analogue (VA) | Pain is evaluated using visual analogue (VA). Assessments will be conducted at baseline and once every six weeks thereafter. | Baseline, 6 week, 12 week | 
| Changes in the Geriatric Depression Scale (GDS) | Depressive symptoms are measured using the Geriatric Depression Scale (GDS). GDS consists of 30 questions and each question is scored as either 0 or 1 points. Overall, the total score 0-9 serves as normal, 10-19 as mildly depressed, and 20-30 as severely depressed. Assessments will be conducted at baseline and once every six weeks thereafter. | Baseline, 6 week, 12 week | 
| Changes in Insonmia Severity Index (ISI) | Sleep parameters are measured using Insonmia Severity Index (ISI). Assessments will be conducted at baseline and once every six weeks thereafter. | Baseline, 6 week, 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Cognitive impairment, Elderly, Acupuncture, CAT, Acupressure, CAE