NCT04305951

Combining Acupuncture and Acupressure for Dementia Elderly

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

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 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.

Conditions

• Dementia

Interventions

Type	Name	Description
PROCEDURE	Comprehensive acupuncture therapy (CAT)	CAT will be conducted for 2 sessions per week for 12 consecutive weeks. The following 14 body acupoints with only manual stimulation will be used: HT7 (Shenmen), LI4 (Hegu), TH5 (Waiguan), ST36 (Zusanli), ST40 (Fenglong) and SP6 (Sanyinjiao) in two sides, and CV12 (Zhongwan) and CV4 (Guanyuan) in midline. Electrical stimulation will be conducted on the following frontal acupoints: GV20 (Baihui), EX-HN3 (Yintang), GB15 (Toulinqi), GB8 (Shuaigu), EX-HN5 (Taiyang), and ST8 (Touwei) on two sides, and left and right EX-HN1 (Sishencong). Disposable acupuncture needles (0.25 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 minutes.
PROCEDURE	Comfy Acupressure for the Elderly (CAE)	CAE intervention will be conducted for 3 times per week for 12 consecutive weeks. CAE consists of 12 steps which need about 15 minutes 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.

Timeline

• Start date: 2021-10-05
• Primary completion: 2024-08-27
• Completion: 2025-02-28
• First posted: 2020-03-12
• Last updated: 2026-02-10
• Results posted: 2026-02-10

Locations

1 site across 1 country: Hong Kong