- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04305951
Combining Acupuncture and Acupressure for Community-dwelling Elderly With Dementia
Combining Acupuncture and Acupressure for Community-dwelling Elderly With Dementia: an Assessor-blinded, Randomized Controlled Trial
Study Overview
Status
Conditions
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 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhang-Jin Zhang, MMed, PhD
- Phone Number: +852 3917 6445
- Email: zhangzj@hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong, 000000
- Recruiting
- The University of Hong Kong
-
Contact:
- Zhang-Jin Zhang, MMed, PhD
- Phone Number: +852 3917 6445
- Email: zhangzj@hku.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Routine care group
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
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
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. |
Active Comparator: CAE group
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
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. |
Active Comparator: CAT + CAE group
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline, 6 week, 12 week
|
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
Time Frame: Baseline, 6 week, 12 week
|
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)
Time Frame: Baseline, 6 week, 12 week
|
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)
Time Frame: Baseline, 6 week, 12 week
|
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)
Time Frame: Baseline, 6 week, 12 week
|
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)
Time Frame: Baseline, 6 week, 12 week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zhang-Jin Zhang, MMed, PhD, School of Chinese Medicine, The University of Hong Kong
Publications and helpful links
General Publications
- Zhang ZJ, Wang XM, McAlonan GM. Neural acupuncture unit: a new concept for interpreting effects and mechanisms of acupuncture. Evid Based Complement Alternat Med. 2012;2012:429412. doi: 10.1155/2012/429412. Epub 2012 Mar 8.
- Zhang ZJ, Ng R, Man SC, Li TY, Wong W, Tan QR, Wong HK, Chung KF, Wong MT, Tsang WK, Yip KC, Ziea E, Wong VT. Dense cranial electroacupuncture stimulation for major depressive disorder--a single-blind, randomized, controlled study. PLoS One. 2012;7(1):e29651. doi: 10.1371/journal.pone.0029651. Epub 2012 Jan 6. Erratum In: PLoS One. 2012 Feb 21;78(8). doi: 10.1371/annotation/b27d20b4-f41c-47af-b19f-a0278c993a2d.
- Man SC, Hung BH, Ng RM, Yu XC, Cheung H, Fung MP, Li LS, Leung KP, Leung KP, Tsang KW, Ziea E, Wong VT, Zhang ZJ. A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression. BMC Complement Altern Med. 2014 Jul 19;14:255. doi: 10.1186/1472-6882-14-255.
- Qu SS, Huang Y, Zhang ZJ, Chen JQ, Lin RY, Wang CQ, Li GL, Wong HK, Zhao CH, Pan JY, Guo SC, Zhang YC. A 6-week randomized controlled trial with 4-week follow-up of acupuncture combined with paroxetine in patients with major depressive disorder. J Psychiatr Res. 2013 Jun;47(6):726-32. doi: 10.1016/j.jpsychires.2013.02.004. Epub 2013 Mar 14.
- Yeung WF, Ho FY, Chung KF, Zhang ZJ, Yu BY, Suen LK, Chan LY, Chen HY, Ho LM, Lao LX. Self-administered acupressure for insomnia disorder: a pilot randomized controlled trial. J Sleep Res. 2018 Apr;27(2):220-231. doi: 10.1111/jsr.12597. Epub 2017 Sep 8.
- Kwan RYC, Leung MCP, Lai CKY. A Randomized Controlled Trial Examining the Effect of Acupressure on Agitation and Salivary Cortisol in Nursing Home Residents with Dementia. Dement Geriatr Cogn Disord. 2017;44(1-2):92-104. doi: 10.1159/000478739. Epub 2017 Jul 29.
- Chung KF, Yeung WF, Yu BY, Leung FC, Zhang SP, Zhang ZJ, Ng RM, Yiu GC. Acupuncture with or without combined auricular acupuncture for insomnia: a randomised, waitlist-controlled trial. Acupunct Med. 2018 Feb;36(1):2-13. doi: 10.1136/acupmed-2017-011371. Epub 2017 Dec 11.
- Chan CWC, Chau PH, Leung AYM, Lo KC, Shi H, Yum TP, Lee YY, Li L. Acupressure for frail older people in community dwellings-a randomised controlled trial. Age Ageing. 2017 Nov 1;46(6):957-964. doi: 10.1093/ageing/afx050.
- Hmwe NTT, Browne G, Mollart L, Allanson V, Chan SW. An integrative review of acupressure interventions for older people: A focus on sleep quality, depression, anxiety, and agitation. Int J Geriatr Psychiatry. 2019 Mar;34(3):381-396. doi: 10.1002/gps.5031. Epub 2018 Dec 10.
- Margenfeld F, Klocke C, Joos S. Manual massage for persons living with dementia: A systematic review and meta-analysis. Int J Nurs Stud. 2019 Aug;96:132-142. doi: 10.1016/j.ijnurstu.2018.12.012. Epub 2019 Jan 4.
- Simoncini M, Gatti A, Quirico PE, Balla S, Capellero B, Obialero R, D'Agostino S, Sandri N, Pernigotti LM. Acupressure in insomnia and other sleep disorders in elderly institutionalized patients suffering from Alzheimer's disease. Aging Clin Exp Res. 2015 Feb;27(1):37-42. doi: 10.1007/s40520-014-0244-9. Epub 2014 May 31.
- Toosizadeh N, Lei H, Schwenk M, Sherman SJ, Sternberg E, Mohler J, Najafi B. Does integrative medicine enhance balance in aging adults? Proof of concept for the benefit of electroacupuncture therapy in Parkinson's disease. Gerontology. 2015;61(1):3-14. doi: 10.1159/000363442. Epub 2014 Oct 22.
- Wang S, Yang H, Zhang J, Zhang B, Liu T, Gan L, Zheng J. Efficacy and safety assessment of acupuncture and nimodipine to treat mild cognitive impairment after cerebral infarction: a randomized controlled trial. BMC Complement Altern Med. 2016 Sep 13;16(1):361. doi: 10.1186/s12906-016-1337-0.
- Wu YT, Ali GC, Guerchet M, Prina AM, Chan KY, Prince M, Brayne C. Prevalence of dementia in mainland China, Hong Kong and Taiwan: an updated systematic review and meta-analysis. Int J Epidemiol. 2018 Jun 1;47(3):709-719. doi: 10.1093/ije/dyy007.
- Yang A, Wu HM, Tang JL, Xu L, Yang M, Liu GJ. Acupuncture for stroke rehabilitation. Cochrane Database Syst Rev. 2016 Aug 26;2016(8):CD004131. doi: 10.1002/14651858.CD004131.pub3.
- Yang JW, Shi GX, Zhang S, Tu JF, Wang LQ, Yan CQ, Lin LL, Liu BZ, Wang J, Sun SF, Yang BF, Wu LY, Tan C, Chen S, Zhang ZJ, Fisher M, Liu CZ. Effectiveness of acupuncture for vascular cognitive impairment no dementia: a randomized controlled trial. Clin Rehabil. 2019 Apr;33(4):642-652. doi: 10.1177/0269215518819050. Epub 2019 Jan 23.
- Yang MH, Lin LC, Wu SC, Chiu JH, Wang PN, Lin JG. Comparison of the efficacy of aroma-acupressure and aromatherapy for the treatment of dementia-associated agitation. BMC Complement Altern Med. 2015 Mar 29;15:93. doi: 10.1186/s12906-015-0612-9.
- Yeung WF, Chung KF, Tso KC, Zhang SP, Zhang ZJ, Ho LM. Electroacupuncture for residual insomnia associated with major depressive disorder: a randomized controlled trial. Sleep. 2011 Jun 1;34(6):807-15. doi: 10.5665/SLEEP.1056.
- Yue S, Jiang X, Wong T. Effects of a nurse-led acupressure programme for stroke patients in China. J Clin Nurs. 2013 Apr;22(7-8):1182-8. doi: 10.1111/j.1365-2702.2012.04127.x. Epub 2012 Jul 17.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 19-821
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden
Clinical Trials on Comprehensive acupuncture therapy (CAT) (Hwato®/ Dongbang®)
-
The University of Hong KongTung Wah Hospital; Kowloon Hospital, Hong KongCompletedDepression | StrokeHong Kong
-
Amina AltutunjiHuazhong University of Science and TechnologyCompleted
-
The University of Hong KongQueen Mary Hospital, Hong Kong; Kowloon Hospital, Hong Kong; Southern Medical...CompletedDepression | Major Depressive DisorderChina, Hong Kong
-
Dana-Farber Cancer InstituteEMD Serono; National Comprehensive Cancer NetworkNot yet recruitingBladder Cancer | Urothelial Carcinoma | Metastatic Bladder Cancer | Unresectable Bladder CarcinomaUnited States
-
University of MinnesotaMedica FoundationCompletedHypertension | Diabetes | HyperlipidemiaUnited States