Combining Acupuncture and Acupressure for Dementia Elderly

Not Applicable

Recruiting

• Conditions: Dementia
• Interventions: Procedure: Comprehensive acupuncture therapy (CAT); Procedure: Comfy Acupressure for the Elderly (CAE)

• Registration Number: NCT04305951
• Lead Sponsor: The University of Hong Kong

Brief Summary

This is an assessor-blinded, randomized controlled trial. A total of 248 elderly people aged ≥65 years with a mid-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 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

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 s 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, 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 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 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 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 dementia elderly.

Study Timeline

• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-12
• Study Start: 2021-10-05
• Primary Completion: 2024-08-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 248

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAT group	Comprehensive acupuncture therapy (CAT)	Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
CAE group	Comfy Acupressure for the Elderly (CAE)	Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE group	Comprehensive acupuncture therapy (CAT)	Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
CAT + CAE group	Comfy Acupressure for the Elderly (CAE)	Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.

Primary Outcome Measures

Name	Time	Method
Changes in the Montreal Cognitive Assessment score	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Digit span test	Baseline, 6 week, 12 week	Attentional function and working memory is measured using Digit span test, and is evaluated in two formats, Forward Digit Span and Reverse Digit Span, with a total possible score of 14 points respectively. A higher score indicates better working memory. Assessments will be conducted at baseline and once every six weeks thereafter.
Changes in the Modified Bathel Index score	Baseline, 6 week, 12 week	Functional independence is measured using Modified Bathel Index (MBI) and its overall score ranges from 10 to 50. A higher score indicates better functional independence. Assessments will be conducted at baseline and once every six weeks thereafter.
Changes in the visual analogue scale score	Baseline, 6 week, 12 week	Pain is evaluated using visual analogue scale (VAS) and its overall score ranges from 0 to 10. A higher score indicates greater severity. Assessments will be conducted at baseline and once every six weeks thereafter.
Changes in the Geriatric Depression Scale score	Baseline, 6 week, 12 week	Depressive symptoms are measured using the 15-item Geriatric Depression Scale (GDS) and its overall score ranges from 0 to 15. A higher score indicates greater severity. Assessments will be conducted at baseline and once every six weeks thereafter.
Changes in the Insomnia Severity Index score	Baseline, 6 week, 12 week	Sleep parameters are measured using Insomnia Severity Index (ISI) and its overall score ranges from 0 to 28. A higher score indicates more acute sleep disturbances. Assessments will be conducted at baseline and once every six weeks thereafter.

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong