DOI QR코드

DOI QR Code

SoUth Korean study to PrEvent cognitive impaiRment and protect BRAIN health through Multidomain interventions via facE-to-facE and video communication plaTforms in mild cognitive impairment (SUPERBRAIN-MEET): Protocol for a Multicenter Randomized Controlled Trial

  • Soo Hyun Cho (Department of Neurology, Chonnam National University Medical School and Chonnam National University Hospital) ;
  • Hae Jin Kang (Department of Medical Nutrition (AgeTech-Service Convergence Major), Graduate School of East-West Medical Science, Kyung Hee University) ;
  • Yoo Kyoung Park (Department of Medical Nutrition (AgeTech-Service Convergence Major), Graduate School of East-West Medical Science, Kyung Hee University) ;
  • So Young Moon (Department of Neurology, Ajou University School of Medicine) ;
  • Chang Hyung Hong (Department of Psychiatry, Ajou University School of Medicine) ;
  • Hae Ri Na (Department of Neurology, Bobath Memorial Hospital) ;
  • Hong-Sun Song (Department of Sports Sciences, Korea Institute of Sports Science) ;
  • Muncheong Choi (Department of Neurology, Ajou University School of Medicine) ;
  • Sooin Jeong (Department of Psychiatry, Ajou University School of Medicine) ;
  • Kyung Won Park (Department of Neurology, Dong-A University College of Medicine) ;
  • Hyun Sook Kim (Department of Neurology, CHA Bundang Medical Center, CHA University) ;
  • Buong-O Chun (Graduate School of Physical Education, College of Arts and Physical Education, Myongi University) ;
  • Jiwoo Jung (Rowan Inc.) ;
  • Jee Hyang Jeong (Department of Neurology, Ewha Womans University College of Medicine) ;
  • Seong Hye Choi (Department of Neurology, Inha University College of Medicine)
  • 투고 : 2023.12.29
  • 심사 : 2024.01.18
  • 발행 : 2024.01.31

초록

Background and Purpose: The SoUth Korea study to PrEvent cognitive impaiRment and protect BRAIN health through lifestyle intervention (SUPERBRAIN) proved the feasibility of multidomain intervention for elderly people. One-quarter of the Korean population over 65 years of age has mild cognitive impairment (MCI). Digital health interventions may be cost-effective and have fewer spatial constraints. We aim to examine the efficacy of a multidomain intervention through both face-to-face interactions and video communication platforms using a tablet personal computer (PC) application in MCI. Methods: Three hundred participants aged 60-85 years, with MCI and at least one modifiable dementia risk factor, will be recruited from 17 centers and randomly assigned in a 1:1 ratio to the multidomain intervention and the waiting-list control groups. Participants will receive the 24-week intervention through the tablet PC SUPERBRAIN application, which encompasses the following five elements: managing metabolic and vascular risk factors, cognitive training, physical exercise, nutritional guidance, and boosting motivation. Participants will attend the interventions at a facility every 1-2 weeks. They will also engage in one or two self-administered cognitive training sessions utilizing the tablet PC application at home each week. They will participate in twice or thrice weekly online exercise sessions at home via the ZOOM platform. The primary outcome will be the change in the total scale index score of the Repeatable Battery for the Assessment of Neuropsychological Status from baseline to study end. Conclusions: This study will inform the effectiveness of a comprehensive multidomain intervention utilizing digital technologies in MCI.

키워드

과제정보

This study was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI) and Korea Dementia Research Center (KDRC) funded by the Ministry of Health and Welfare and Ministry of Science and ICT, Republic of Korea (HU21C0016), grants from the National Research Council of Science and Technology (NST) Aging Convergence Research Center (CRC22011-600) and the Institute of Information and Communications Technology Planning and Evaluation (IITP) (2022-0-00448) funded by the Ministry of Science and ICT, Republic of Korea, and grants from Chonnam National University (Grant numbers 2021-2207 and 2022-2648). The funders were not involved in the study design, operations such as the selection and management of sites, writing of the report, and the decision to submit the report for publication, and do not have ultimate authority over any of these activities.

참고문헌

  1. Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, et al. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet 2020;396:413-446. https://doi.org/10.1016/S0140-6736(20)30367-6
  2. Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, et al. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet 2015;385:2255-2263.  https://doi.org/10.1016/S0140-6736(15)60461-5
  3. World Health Organization. Risk Reduction of Cognitive Decline and Dementia: WHO Guidelines. Geneva: World Health Organization; 2019.
  4. Kivipelto M, Mangialasche F, Snyder HM, Allegri R, Andrieu S, Arai H, et al. World-Wide FINGERS Network: a global approach to risk reduction and prevention of dementia. Alzheimers Dement 2020;16:1078-1094. https://doi.org/10.1002/alz.12123
  5. Park HK, Jeong JH, Moon SY, Park YK, Hong CH, Na HR, et al. South Korean study to prevent cognitive impairment and protect brain health through lifestyle intervention in at-risk elderly people: protocol of a multicenter, randomized controlled feasibility trial. J Clin Neurol 2020;16:292-303. https://doi.org/10.3988/jcn.2020.16.2.292
  6. Moon SY, Hong CH, Jeong JH, Park YK, Na HR, Song HS, et al. Facility-based and home-based multidomain interventions including cognitive training, exercise, diet, vascular risk management, and motivation for older adults: a randomized controlled feasibility trial. Aging (Albany NY) 2021;13:15898-15916. https://doi.org/10.18632/aging.203213
  7. Andrieu S, Guyonnet S, Coley N, Cantet C, Bonnefoy M, Bordes S, et al. Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet Neurol 2017;16:377-389. https://doi.org/10.1016/S1474-4422(17)30040-6
  8. Salvado G, Larsson V, Cody KA, Cullen NC, Jonaitis EM, Stomrud E, et al. Optimal combinations of CSF biomarkers for predicting cognitive decline and clinical conversion in cognitively unimpaired participants and mild cognitive impairment patients: a multi-cohort study. Alzheimers Dement 2023;19:2943-2955.  https://doi.org/10.1002/alz.12907
  9. Lee EH, Kim GH, Park HK, Kang HJ, Park YK, Lee HA, et al. Effects of the multidomain intervention with nutritional supplements on cognition and gut microbiome in early symptomatic Alzheimer's disease: a randomized controlled trial. Front Aging Neurosci 2023;15:1266955.
  10. Schneider JA, Arvanitakis Z, Bang W, Bennett DA. Mixed brain pathologies account for most dementia cases in community-dwelling older persons. Neurology 2007;69:2197-2204. https://doi.org/10.1212/01.wnl.0000271090.28148.24
  11. Aydin N, Sayir MF, Aydeniz S, Simsek T. How Did COVID-19 Change Faculty Members' Use of Technology? SAGE Open 2023;13:21582440221149720.
  12. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
  13. Song M, Jahng S, Kim S, Kang Y. A normative study of the full version of story memory in the KoreanMini Mental State Examination, 2nd Edition: Expanded Version (K-MMSE-2: EV). Dement Neurocogn Disord 2020;19:161-169. https://doi.org/10.12779/dnd.2020.19.4.161
  14. Chalmers J, MacMahon S, Mancia G, Whitworth J, Beilin L, Hansson L, et al. 1999 World Health Organization-International Society of Hypertension Guidelines for the management of hypertension. Guidelines sub-committee of the World Health Organization. Clin Exp Hypertens 1999;21:1009-1060.  https://doi.org/10.3109/10641969909061028
  15. American Diabetes Association. 2. Classification and diagnosis of diabetes: standards of medical care in diabetes-2018. Diabetes Care 2018;41 Suppl 1:S13-S27. https://doi.org/10.2337/dc18-S002
  16. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (adult treatment panel III) final report. Circulation 2002;106:3143-3421. https://doi.org/10.1161/circ.106.25.3143
  17. Pan WH, Yeh WT. How to define obesity? Evidence-based multiple action points for public awareness, screening, and treatment: an extension of Asian-Pacific recommendations. Asia Pac J Clin Nutr 2008;17:370-374.
  18. Nam GE, Park HS. Perspective on diagnostic criteria for obesity and abdominal obesity in Korean adults. J Obes Metab Syndr 2018;27:134-142. https://doi.org/10.7570/jomes.2018.27.3.134
  19. Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, et al. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation 2009;120:1640-1645. https://doi.org/10.1161/CIRCULATIONAHA.109.192644
  20. Centers for Disease Control and Prevention (CDC). Cigarette smoking among adults--United States, 1992, and changes in the definition of current cigarette smoking. MMWR Morb Mortal Wkly Rep 1994;43:342-346. 
  21. Minn YK, Choi SH, Suh YJ, Jeong JH, Kim EJ, Kim JH, et al. Effect of physical activity on the progression of Alzheimer's disease: the Clinical Research Center for Dementia of South Korea study. J Alzheimers Dis 2018;66:249-261. https://doi.org/10.3233/JAD-180333
  22. Akbaraly TN, Portet F, Fustinoni S, Dartigues JF, Artero S, Rouaud O, et al. Leisure activities and the risk of dementia in the elderly: results from the Three-City Study. Neurology 2009;73:854-861. https://doi.org/10.1212/WNL.0b013e3181b7849b
  23. Hosking DE, Eramudugolla R, Cherbuin N, Anstey KJ. MIND not Mediterranean diet related to 12-year incidence of cognitive impairment in an Australian longitudinal cohort study. Alzheimers Dement 2019;15:581-589. https://doi.org/10.1016/j.jalz.2018.12.011
  24. Kwak HW, Kim JY, Park JO, Park HG, Bai DS, Im JM, et al. Korean Version of Repeatable Battery for the Assessment of Neuropsychological Status: Update. Daegu: Korea Psychology; 2018.
  25. Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol 1998;20:310-319.  https://doi.org/10.1076/jcen.20.3.310.823
  26. Choi SH, Lee BH, Kim S, Hahm DS, Jeong JH, Yoon SJ, et al. Interchanging scores between clinical dementia rating scale and global deterioration scale. Alzheimer Dis Assoc Disord 2003;17:98-105. https://doi.org/10.1097/00002093-200304000-00008
  27. Byun E, Kim KK. Prospective and retrospective memory failures in persons with memory complaints: a questionnaire study. Dement Neurocogn Disord 2009;8:45-52.
  28. Bae JN, Cho MJ. Development of the Korean version of the Geriatric Depression Scale and its short form among elderly psychiatric patients. J Psychosom Res 2004;57:297-305. https://doi.org/10.1016/j.jpsychores.2004.01.004
  29. Choi SH, Na DL, Lee BH, Kang SJ, Ha CK, Han SH, et al. Validation of the Korean version of the Bayer activities of daily living scale. Hum Psychopharmacol 2003;18:469-475. https://doi.org/10.1002/hup.505
  30. Shin HY. [A preliminary study on the Korean version of quality of life-Alzheimer's disease (QOL-AD) scale in community-dwelling elderly with dementia]. J Prev Med Public Health 2006;39:243-248.
  31. Lee J, Lee C, Min J, Kang DW, Kim JY, Yang HI, et al. Development of the Korean Global Physical Activity Questionnaire: reliability and validity study. Glob Health Promot 2020;27:44-55. https://doi.org/10.1177/1757975919854301
  32. Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med 1995;332:556-561. https://doi.org/10.1056/NEJM199503023320902
  33. Chung M, Kwak T, Kim H, Kang MH, Lee JS, Chung HR, et al. Development of NQ-E, Nutrition Quotient for Korean elderly: item selection and validation of factor structure. J Nutr Health 2018;51:87-102.  https://doi.org/10.4163/jnh.2018.51.1.87
  34. Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, et al. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition 1999;15:116-122. https://doi.org/10.1016/S0899-9007(98)00171-3
  35. Sohn SI, Kim DH, Lee MY, Cho YW. The reliability and validity of the Korean version of the Pittsburgh Sleep Quality Index. Sleep Breath 2012;16:803-812. https://doi.org/10.1007/s11325-011-0579-9
  36. Choi CH, Park S, Park H, Cho Y, Sohn BK, Lee J. Study on cognitive reserve in Korea using Korean version of cognitive reserve index questionnaire. J Korean Neuropsychiatr Assoc 2016;55:256-263. https://doi.org/10.4306/jknpa.2016.55.3.256
  37. Han JW, Kim TH, Kwak KP, Kim K, Kim BJ, Kim SG, et al. Overview of the Korean longitudinal study on cognitive aging and dementia. Psychiatry Investig 2018;15:767-774. https://doi.org/10.30773/pi.2018.06.02
  38. Kim KW, Park JH, Kim MH, Kim MD, Kim BJ, Kim SK, et al. A nationwide survey on the prevalence of dementia and mild cognitive impairment in South Korea. J Alzheimers Dis 2011;23:281-291. https://doi.org/10.3233/JAD-2010-101221
  39. van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, et al. Lecanemab in early Alzheimer's disease. N Engl J Med 2023;388:9-21. https://doi.org/10.1056/NEJMoa2212948
  40. Sims JR, Zimmer JA, Evans CD, Lu M, Ardayfio P, Sparks J, et al. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA 2023;330:512-527. https://doi.org/10.1001/jama.2023.13239
  41. Choi J, Choi S, Song K, Baek J, Kim H, Choi M, et al. Everyday digital literacy questionnaire for older adults: instrument development and validation study. J Med Internet Res 2023;25:e51616.
  42. Amos JG, Zheng L, Eramudugolla R, Parekh D, Huque MH, Delbaere K, et al. MyCOACH (COnnected Advice for Cognitive Health): a digitally delivered multidomain intervention for cognitive decline and risk of dementia in adults with mild cognitive impairment or subjective cognitive decline-study protocol for a randomised controlled trial. BMJ Open 2023;13:e075015.
  43. Welberry HJ, Chau T, Heffernan M, San Jose JC, Jorm LR, Singh MF, et al. Factors associated with participation in a multidomain web-based dementia prevention trial: evidence from maintain your brain (MYB). J Alzheimers Dis 2023;92:959-974. https://doi.org/10.3233/JAD-220990