Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
Study NCT ID:
NCT03980392
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2019-05-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Independent raters are blinded to the group of participants.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'They will be randomly allocated to facility-based multidomain intervention group, home-based intervention group, and a regular health advice group (referred to as control group) at a ratio of 1:1:1.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retention rate (percent) of the participants', 'timeFrame': '6 months', 'description': 'Retention rate in each intervention group'}, {'measure': 'compliance (percent)', 'timeFrame': '6 months', 'description': 'Compliance to the protocol in each intervention group'}, {'measure': 'Change of cognition', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.'}], 'secondaryOutcomes': [{'measure': 'Change of global cognition', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition.'}, {'measure': 'Change of function', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Clinical Dementia Rating scale-Sum of Boxes (sum, range 0-18) / Higher scores mean worse function.'}, {'measure': 'Change of depression', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion.'}, {'measure': 'Change of subjective memory complaints', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Prospective and Retrospective Memory Questionnaire (sum, range 18-80) / Higher scores mean worse memory.'}, {'measure': 'Change of memory complaints', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory.'}, {'measure': 'Change of prospective memory', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Prospective Memory test (sum, range 0-12) / Higher scores mean better memory.'}, {'measure': 'Change of Quality of life (QOL)', 'timeFrame': 'Change at 6 months from baseline', 'description': "QOL-Alzheimer's disease (sum, rage 0-52) / Higher scores mean better QOL."}, {'measure': 'Change of activities of daily livings (ADL)', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL.'}, {'measure': 'Change of nutritional status', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition.'}, {'measure': 'Change of nutrition', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition.'}, {'measure': 'Change of balance', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function.'}, {'measure': 'Change of physical activity', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Global Physical Activity Questionnaire (This is not scoring.)'}, {'measure': 'Change of motivation', 'timeFrame': 'Change at 6 months from baseline', 'description': 'Motivation Questionnaire subscore 1) Situational Motivation Type Scale (sum, range 4-28) / Higher scores mean better motivation.\n\nsubscore 2) Self-efficacy (sum, range 4-20) / Higher scores mean better motivation.'}, {'measure': 'Adverse event (number of participants)', 'timeFrame': 'Up to 24 weeks', 'description': 'adverse event in each group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prevention', 'dementia', 'intervention', 'mild cognitive impairment'], 'conditions': ['Mild Cognitive Impairment', 'Aged']}, 'referencesModule': {'references': [{'pmid': '36805537', 'type': 'DERIVED', 'citation': 'Han MH, Lee EH, Park HH, Choi SH, Koh SH. Relationship between telomere shortening and early subjective depressive symptoms and cognitive complaints in older adults. Aging (Albany NY). 2023 Feb 17;15(4):914-931. doi: 10.18632/aging.204533. Epub 2023 Feb 17.'}, {'pmid': '36313025', 'type': 'DERIVED', 'citation': 'Park HK, Choi SH, Kim S, Park U, Kang SW, Jeong JH, Moon SY, Hong CH, Song HS, Chun BO, Lee SM, Choi M, Park KW, Kim BC, Cho SH, Na HR, Park YK. Functional brain changes using electroencephalography after a 24-week multidomain intervention program to prevent dementia. Front Aging Neurosci. 2022 Oct 12;14:892590. doi: 10.3389/fnagi.2022.892590. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates acceptability and efficacy of multidomain intervention program to prevent cognitive impairment and protect brain health in Korean at-risk elderly. A third of participants will receive facility-based intervention for 6 months, a third will receive home-based intervention for 6 months, and a third is waiting list controls.', 'detailedDescription': "Despite extensive research in the field of Alzheimer's disease (AD), no treatment has yet been developed to modify the progression of AD. Therefore, it is important to manage vascular and metabolic risk factors, to eat healthy foods, to exercise, and to participate in social activities to prevent dementia. The FINGER study showed that the multi-domain intervention program is effective to prevent cognitive impairment and disability in elderly.\n\nIn South Korea, exercise and leisure programs, and brain activity for the elderly also have been conducted in welfare centers and public health centers. However, there are not enough programs that have proven effective in the studies.\n\nSo the investigators would like to develop a multi-domain intervention program and investigate applicability and efficacy before a large-scale randomized controlled trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged 60-79\n2. Having at least one among the following dementia risks,\n\n * hypertension\n * Diabetes Mellitus\n * Dyslipidemia\n * Obesity\n * Abdominal obesity\n * Metabolic syndrome\n * Smoking\n * educational level ≤ 9 years\n * Physical inactivity\n * Social inactivity\n3. Independent activities of daily living\n4. Mini-Mental State Examination score better than1.5 standard deviations below age and education-adjusted normative means\n5. Can read and write Korean\n6. Having a reliable informant who could provide investigators with the requested information.\n7. Provide written informed consent\n\nExclusion Criteria:\n\n1. Major psychiatric illness such as major depressive disorders\n2. Dementia\n3. Substantial cognitive decline\n4. Other degenerative disease (e.g., Parkinson's disease)\n5. Malignancy within 5 years\n6. Cardiac stent or revascularization within 1 year\n7. Serious or unstable symptomatic cardiovascular disease\n8. Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease\n9. Severe loss of vision, hearing, or communicative disability\n10. Any conditions preventing cooperation as judged by the study physician\n11. Significant laboratory abnormality that may result in cognitive impairment\n12. Unable to participate in exercise program safely\n13. Coincident participation in any other intervention trial"}, 'identificationModule': {'nctId': 'NCT03980392', 'acronym': 'SUPERBRAIN', 'briefTitle': 'South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Inha University Hospital'}, 'officialTitle': 'A Randomized Controlled Study to Evaluate Applicability of Korean Multidomain Intervention Program in the South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention', 'orgStudyIdInfo': {'id': 'HI18C0479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Facility-based Intervention', 'description': 'A group will consist of 5 or 10 persons depending on the size of the study center. Exercise training will be guided by study exercise therapists at a gym and consist of programs for progressive muscle strength training, aerobic exercise, and exercises to improve postural balance and flexibility using elastic bands, floor plate and chairs (three times per week, 60 min per session).The cognitive training program is a program including tasks to be effective in episodic memory, executive function, attention, working memory, calculation, and visuospatial function (twice per week, 60 min per session). The nutritional intervention is conducted by study nutritionists (three individual sessions and seven group sessions). Management of metabolic and vascular risk factors will include additional meetings with the study nurse (at 0, 4, 8, 16, and 20 weeks), and the study physician (at 0 and 12 weeks). Motivational training is conducted by psychologist (four group session).', 'interventionNames': ['Other: Multidomain intervention program']}, {'type': 'EXPERIMENTAL', 'label': 'Home-based Intervention', 'description': 'The nutritional intervention, management of metabolic and vascular risk factors, social activity, and motivational training in the home-based intervention are similar to the facility-based intervention. The physical exercise programs consist of one group session (60 min) and two home-based sessions (60 min per session) per week in the first 2 months of the trial. During the remaining months of the 6-month study, participants in the home-based intervention attend a 1-h physical exercise group session per two weeks and two or three exercise sessions (60 min per session) alone at home per week. The cognitive training programs consist of one group session (60 min) and one home-based sessions (60 min per session) per week in the first 2 months of the trial. For the remainder of the 6-month study, participants in the home-based intervention attend a 1-h group cognitive training session per two weeks and one or two cognitive training sessions (60 min per session) alone at home per week.', 'interventionNames': ['Other: Multidomain intervention program']}, {'type': 'NO_INTERVENTION', 'label': 'Controls', 'description': 'They are waiting list controls. They will receive the multi-domain intervention after this study.'}], 'interventions': [{'name': 'Multidomain intervention program', 'type': 'OTHER', 'description': 'Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation', 'armGroupLabels': ['Facility-based Intervention', 'Home-based Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha Univeristy Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Bobath Memorial Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Jee Hyang Jeong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ewha Womans University Hospital'}, {'name': 'So Young Moon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University Hospital, Neurology'}, {'name': 'Chang Hyung Hong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University Hospital, Psychiatry'}, {'name': 'Hae Ri Na, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bobath Memorial Hospital'}, {'name': 'Kyung Won Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dong-A University Hospital'}, {'name': 'Byung Chae Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}, {'name': 'Yoo Kyoung Park, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyunghee University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will decide it later.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inha University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korea Health Industry Development Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor Seong Hye Choi', 'investigatorFullName': 'Inha University Hospital', 'investigatorAffiliation': 'Inha University Hospital'}}}}