South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention (SUPERBRAIN)

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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Aged
• Intervention / Treatment: Other: Multidomain intervention program

Detailed Description

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.

In 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.

So the investigators would like to develop a multi-domain intervention program and investigate applicability and efficacy before a large-scale randomized controlled trial.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of, 400-711
    • Inha Univeristy Hospital
  • Pusan, Korea, Republic of
    • Dong-A University Hospital
  • Seongnam, Korea, Republic of
    • Bobath Memorial Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University MokDong Hospital
  • Suwon, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 60-79

2. Having at least one among the following dementia risks,

   • hypertension
   • Diabetes Mellitus
   • Dyslipidemia
   • Obesity
   • Abdominal obesity
   • Metabolic syndrome
   • Smoking
   • educational level ≤ 9 years
   • Physical inactivity
   • Social inactivity
3. Independent activities of daily living
4. Mini-Mental State Examination score better than1.5 standard deviations below age and education-adjusted normative means
5. Can read and write Korean
6. Having a reliable informant who could provide investigators with the requested information.
7. Provide written informed consent

Exclusion Criteria:

1. Major psychiatric illness such as major depressive disorders
2. Dementia
3. Substantial cognitive decline
4. Other degenerative disease (e.g., Parkinson's disease)
5. Malignancy within 5 years
6. Cardiac stent or revascularization within 1 year
7. Serious or unstable symptomatic cardiovascular disease
8. Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
9. Severe loss of vision, hearing, or communicative disability
10. Any conditions preventing cooperation as judged by the study physician
11. Significant laboratory abnormality that may result in cognitive impairment
12. Unable to participate in exercise program safely
13. Coincident participation in any other intervention trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facility-based Intervention; 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).	Other: Multidomain intervention program; Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation
Experimental: Home-based Intervention; 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.	Other: Multidomain intervention program; Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation
No Intervention: Controls; They are waiting list controls. They will receive the multi-domain intervention after this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retention rate (percent) of the participants	Retention rate in each intervention group	6 months
compliance (percent)	Compliance to the protocol in each intervention group	6 months
Change of cognition	Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.	Change at 6 months from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of global cognition	Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition.	Change at 6 months from baseline
Change of function	Clinical Dementia Rating scale-Sum of Boxes (sum, range 0-18) / Higher scores mean worse function.	Change at 6 months from baseline
Change of depression	Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion.	Change at 6 months from baseline
Change of subjective memory complaints	Prospective and Retrospective Memory Questionnaire (sum, range 18-80) / Higher scores mean worse memory.	Change at 6 months from baseline
Change of memory complaints	Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory.	Change at 6 months from baseline
Change of prospective memory	Prospective Memory test (sum, range 0-12) / Higher scores mean better memory.	Change at 6 months from baseline
Change of Quality of life (QOL)	QOL-Alzheimer's disease (sum, rage 0-52) / Higher scores mean better QOL.	Change at 6 months from baseline
Change of activities of daily livings (ADL)	Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL.	Change at 6 months from baseline
Change of nutritional status	Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition.	Change at 6 months from baseline
Change of nutrition	Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition.	Change at 6 months from baseline
Change of balance	Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function.	Change at 6 months from baseline
Change of physical activity	Global Physical Activity Questionnaire (This is not scoring.)	Change at 6 months from baseline
Change of motivation	Motivation Questionnaire subscore 1) Situational Motivation Type Scale (sum, range 4-28) / Higher scores mean better motivation. subscore 2) Self-efficacy (sum, range 4-20) / Higher scores mean better motivation.	Change at 6 months from baseline
Adverse event (number of participants)	adverse event in each group	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Inha University Hospital
• Collaborators: Korea Health Industry Development Institute
• Investigators: Principal Investigator: Jee Hyang Jeong, MD, PhD, Ewha Womans University Hospital; Principal Investigator: So Young Moon, MD, PhD, Ajou University Hospital, Neurology; Principal Investigator: Chang Hyung Hong, MD, PhD, Ajou University Hospital, Psychiatry; Principal Investigator: Hae Ri Na, MD, PhD, Bobath Memorial Hospital; Principal Investigator: Kyung Won Park, MD, PhD, Dong-A University Hospital; Principal Investigator: Byung Chae Kim, MD, PhD, Chonnam National University Hospital; Study Director: Yoo Kyoung Park, PhD, Kyunghee University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): February 14, 2020
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: dementia; prevention; intervention; mild cognitive impairment
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: HI18C0479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We will decide it later.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No