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Electroacupuncture for older adults with mild cognitive impairment: study protocol for a randomized controlled trial.

Abstract

BACKGROUND

Mild cognitive impairment is an intermediary state between normal aging and clinical Alzheimer's disease. Early intervention of mild cognitive impairment may be an important strategy in the management of Alzheimer's disease. The proposal aims to evaluate if electroacupuncture would optimize cognitive function in subjects with mild cognitive impairment and understand the role of electroacupuncture in the treatment of Alzheimer's disease.

METHODS/DESIGN

A randomised patient- and assessor-blind sham-controlled trial is designed to assess whether electroacupuncture intervention decreases the rate of cognitive decline amongst older adults with mild cognitive impairment. One hundred and fifty subjects aged 65 years of age or over with a diagnosis of mild cognitive impairment are recruited from the community and elderly centre in Hong Kong. All subjects are randomly allocated into two groups (75 subjects each group): the electroacupuncture group and sham control. Participants in the electroacupuncture group receive electroacupuncture stimulation by sterile, disposable acupuncture needles inserted to the acupoints with a depth of 1 to 3 cm. The acupuncture needles are subjected to 2 Hz electroacupuncture with an intensity of 5 to 10 mA. Each participant receives electroacupuncture for 8 weeks (once a day, 3 days a week) and the treatment lasts for 30 minutes each time. For sham electroacupuncture, needles are inserted to a depth of 1 to 2 mm, and connected to the electroacupuncture device without any current passing through. Outcome measures (including primary and secondary outcome measures) are collected at baseline, at the end day of intervention, and months 4 and 6 after intervention. The primary outcome is measured by the Alzheimer Disease Assessment Scale-Cognitive subscale. Secondary outcomes are measured by the mini-mental state examination, category fluency text and the Short Form 12.

DISCUSSION

The study will provide evidence for evaluating and understanding the role of electroacupuncture in the treatment of Alzheimer's disease.

TRIAL REGISTRATION

This trial is registered with chictr.org (registration number: ChiCTR-TRC-12002414 . Registration date: 11 August 2012.

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  • Authors+Show Affiliations

    ,

    School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong. awnleung@cuhk.edu.hk.

    ,

    Department of Psychiatry, The Chinese University of Hong Kong, Shatin, Hong Kong. cwlam@cuhk.edu.hk.

    ,

    School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong. kwankalun@gmail.com.

    ,

    School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong. celiatsang@cuhk.edu.hk.

    ,

    School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong. zhanghw@cuhk.edu.hk.

    ,

    School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong. cuguoyq@yahoo.com.hk.

    School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong. csxu@cuhk.edu.hk. Shenzhen Research Institute, The Chinese University of Hong Kong, Shenzhen, China. csxu@cuhk.edu.hk.

    Source

    Trials 16: 2015 May 27 pg 232

    MeSH

    Age Factors
    Aged
    Aging
    Clinical Protocols
    Cognition
    Cognitive Dysfunction
    Electroacupuncture
    Female
    Geriatric Assessment
    Hong Kong
    Humans
    Male
    Neuropsychological Tests
    Predictive Value of Tests
    Research Design
    Time Factors
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    26012577

    Citation

    Leung, Albert Wing Nang, et al. "Electroacupuncture for Older Adults With Mild Cognitive Impairment: Study Protocol for a Randomized Controlled Trial." Trials, vol. 16, 2015, p. 232.
    Leung AW, Lam LC, Kwan AK, et al. Electroacupuncture for older adults with mild cognitive impairment: study protocol for a randomized controlled trial. Trials. 2015;16:232.
    Leung, A. W., Lam, L. C., Kwan, A. K., Tsang, C. L., Zhang, H. W., Guo, Y. Q., & Xu, C. S. (2015). Electroacupuncture for older adults with mild cognitive impairment: study protocol for a randomized controlled trial. Trials, 16, p. 232. doi:10.1186/s13063-015-0740-z.
    Leung AW, et al. Electroacupuncture for Older Adults With Mild Cognitive Impairment: Study Protocol for a Randomized Controlled Trial. Trials. 2015 May 27;16:232. PubMed PMID: 26012577.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Electroacupuncture for older adults with mild cognitive impairment: study protocol for a randomized controlled trial. AU - Leung,Albert Wing Nang, AU - Lam,Linda Chiu Wa, AU - Kwan,Andrew Ka Lun, AU - Tsang,Celia Lai Lin, AU - Zhang,Hong Wei, AU - Guo,Yuan Qi, AU - Xu,Chuan Shan, Y1 - 2015/05/27/ PY - 2015/02/02/received PY - 2015/05/05/accepted PY - 2015/5/28/entrez PY - 2015/5/28/pubmed PY - 2016/3/2/medline SP - 232 EP - 232 JF - Trials JO - Trials VL - 16 N2 - BACKGROUND: Mild cognitive impairment is an intermediary state between normal aging and clinical Alzheimer's disease. Early intervention of mild cognitive impairment may be an important strategy in the management of Alzheimer's disease. The proposal aims to evaluate if electroacupuncture would optimize cognitive function in subjects with mild cognitive impairment and understand the role of electroacupuncture in the treatment of Alzheimer's disease. METHODS/DESIGN: A randomised patient- and assessor-blind sham-controlled trial is designed to assess whether electroacupuncture intervention decreases the rate of cognitive decline amongst older adults with mild cognitive impairment. One hundred and fifty subjects aged 65 years of age or over with a diagnosis of mild cognitive impairment are recruited from the community and elderly centre in Hong Kong. All subjects are randomly allocated into two groups (75 subjects each group): the electroacupuncture group and sham control. Participants in the electroacupuncture group receive electroacupuncture stimulation by sterile, disposable acupuncture needles inserted to the acupoints with a depth of 1 to 3 cm. The acupuncture needles are subjected to 2 Hz electroacupuncture with an intensity of 5 to 10 mA. Each participant receives electroacupuncture for 8 weeks (once a day, 3 days a week) and the treatment lasts for 30 minutes each time. For sham electroacupuncture, needles are inserted to a depth of 1 to 2 mm, and connected to the electroacupuncture device without any current passing through. Outcome measures (including primary and secondary outcome measures) are collected at baseline, at the end day of intervention, and months 4 and 6 after intervention. The primary outcome is measured by the Alzheimer Disease Assessment Scale-Cognitive subscale. Secondary outcomes are measured by the mini-mental state examination, category fluency text and the Short Form 12. DISCUSSION: The study will provide evidence for evaluating and understanding the role of electroacupuncture in the treatment of Alzheimer's disease. TRIAL REGISTRATION: This trial is registered with chictr.org (registration number: ChiCTR-TRC-12002414 . Registration date: 11 August 2012. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/26012577/Electroacupuncture_for_older_adults_with_mild_cognitive_impairment:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0740-z DB - PRIME DP - Unbound Medicine ER -