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

Primary Purpose

Mild Cognitive Impairment, Aged

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Multidomain intervention program
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring prevention, dementia, intervention, mild cognitive impairment

Eligibility Criteria

60 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chonnam National University Hospital
  • Inha Univeristy Hospital
  • Dong-A University Hospital
  • Bobath Memorial Hospital
  • Ewha Womans University Mokdong Hospital
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Facility-based Intervention

Home-based Intervention

Controls

Arm 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).

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.

They are waiting list controls. They will receive the multi-domain intervention after this study.

Outcomes

Primary Outcome Measures

retention rate (percent) of the participants
Retention rate in each intervention group
compliance (percent)
Compliance to the protocol in each intervention group
Change of cognition
Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.

Secondary Outcome Measures

Change of global cognition
Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition.
Change of function
Clinical Dementia Rating scale-Sum of Boxes (sum, range 0-18) / Higher scores mean worse function.
Change of depression
Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion.
Change of subjective memory complaints
Prospective and Retrospective Memory Questionnaire (sum, range 18-80) / Higher scores mean worse memory.
Change of memory complaints
Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory.
Change of prospective memory
Prospective Memory test (sum, range 0-12) / Higher scores mean better memory.
Change of Quality of life (QOL)
QOL-Alzheimer's disease (sum, rage 0-52) / Higher scores mean better QOL.
Change of activities of daily livings (ADL)
Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL.
Change of nutritional status
Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition.
Change of nutrition
Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition.
Change of balance
Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function.
Change of physical activity
Global Physical Activity Questionnaire (This is not scoring.)
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.
Adverse event (number of participants)
adverse event in each group

Full Information

First Posted
May 28, 2019
Last Updated
March 2, 2021
Sponsor
Inha University Hospital
Collaborators
Korea Health Industry Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03980392
Brief Title
South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention
Acronym
SUPERBRAIN
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Inha University Hospital
Collaborators
Korea Health Industry Development Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Aged
Keywords
prevention, dementia, intervention, mild cognitive impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Independent raters are blinded to the group of participants.
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facility-based Intervention
Arm Type
Experimental
Arm 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).
Arm Title
Home-based Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Controls
Arm Type
No Intervention
Arm Description
They are waiting list controls. They will receive the multi-domain intervention after this study.
Intervention Type
Other
Intervention Name(s)
Multidomain intervention program
Intervention Description
Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation
Primary Outcome Measure Information:
Title
retention rate (percent) of the participants
Description
Retention rate in each intervention group
Time Frame
6 months
Title
compliance (percent)
Description
Compliance to the protocol in each intervention group
Time Frame
6 months
Title
Change of cognition
Description
Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.
Time Frame
Change at 6 months from baseline
Secondary Outcome Measure Information:
Title
Change of global cognition
Description
Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition.
Time Frame
Change at 6 months from baseline
Title
Change of function
Description
Clinical Dementia Rating scale-Sum of Boxes (sum, range 0-18) / Higher scores mean worse function.
Time Frame
Change at 6 months from baseline
Title
Change of depression
Description
Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion.
Time Frame
Change at 6 months from baseline
Title
Change of subjective memory complaints
Description
Prospective and Retrospective Memory Questionnaire (sum, range 18-80) / Higher scores mean worse memory.
Time Frame
Change at 6 months from baseline
Title
Change of memory complaints
Description
Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory.
Time Frame
Change at 6 months from baseline
Title
Change of prospective memory
Description
Prospective Memory test (sum, range 0-12) / Higher scores mean better memory.
Time Frame
Change at 6 months from baseline
Title
Change of Quality of life (QOL)
Description
QOL-Alzheimer's disease (sum, rage 0-52) / Higher scores mean better QOL.
Time Frame
Change at 6 months from baseline
Title
Change of activities of daily livings (ADL)
Description
Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL.
Time Frame
Change at 6 months from baseline
Title
Change of nutritional status
Description
Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition.
Time Frame
Change at 6 months from baseline
Title
Change of nutrition
Description
Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition.
Time Frame
Change at 6 months from baseline
Title
Change of balance
Description
Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function.
Time Frame
Change at 6 months from baseline
Title
Change of physical activity
Description
Global Physical Activity Questionnaire (This is not scoring.)
Time Frame
Change at 6 months from baseline
Title
Change of motivation
Description
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.
Time Frame
Change at 6 months from baseline
Title
Adverse event (number of participants)
Description
adverse event in each group
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 60-79 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 Independent activities of daily living Mini-Mental State Examination score better than1.5 standard deviations below age and education-adjusted normative means Can read and write Korean Having a reliable informant who could provide investigators with the requested information. Provide written informed consent Exclusion Criteria: Major psychiatric illness such as major depressive disorders Dementia Substantial cognitive decline Other degenerative disease (e.g., Parkinson's disease) Malignancy within 5 years Cardiac stent or revascularization within 1 year Serious or unstable symptomatic cardiovascular disease Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease Severe loss of vision, hearing, or communicative disability Any conditions preventing cooperation as judged by the study physician Significant laboratory abnormality that may result in cognitive impairment Unable to participate in exercise program safely Coincident participation in any other intervention trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jee Hyang Jeong, MD, PhD
Organizational Affiliation
Ewha Womans University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
So Young Moon, MD, PhD
Organizational Affiliation
Ajou University Hospital, Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chang Hyung Hong, MD, PhD
Organizational Affiliation
Ajou University Hospital, Psychiatry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hae Ri Na, MD, PhD
Organizational Affiliation
Bobath Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyung Won Park, MD, PhD
Organizational Affiliation
Dong-A University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Byung Chae Kim, MD, PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoo Kyoung Park, PhD
Organizational Affiliation
Kyunghee University
Official's Role
Study Director
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Inha Univeristy Hospital
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Bobath Memorial Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will decide it later.
Citations:
PubMed Identifier
36313025
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.
Results Reference
derived

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

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