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出境医 / 临床实验 / South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention (SUPERBRAIN)

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

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Aged Other: Multidomain intervention program Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: Independent raters are blinded to the group of participants.
Primary Purpose: Prevention
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
Actual Study Start Date : May 29, 2019
Actual Primary Completion Date : February 14, 2020
Actual Study Completion Date : February 25, 2020
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. retention rate (percent) of the participants [ Time Frame: 6 months ]
    Retention rate in each intervention group

  2. compliance (percent) [ Time Frame: 6 months ]
    Compliance to the protocol in each intervention group

  3. Change of cognition [ Time Frame: Change at 6 months from baseline ]
    Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.


Secondary Outcome Measures :
  1. Change of global cognition [ Time Frame: Change at 6 months from baseline ]
    Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition.

  2. Change of function [ Time Frame: Change at 6 months from baseline ]
    Clinical Dementia Rating scale-Sum of Boxes (sum, range 0-18) / Higher scores mean worse function.

  3. Change of depression [ Time Frame: Change at 6 months from baseline ]
    Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion.

  4. Change of subjective memory complaints [ Time Frame: Change at 6 months from baseline ]
    Prospective and Retrospective Memory Questionnaire (sum, range 18-80) / Higher scores mean worse memory.

  5. Change of memory complaints [ Time Frame: Change at 6 months from baseline ]
    Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory.

  6. Change of prospective memory [ Time Frame: Change at 6 months from baseline ]
    Prospective Memory test (sum, range 0-12) / Higher scores mean better memory.

  7. Change of Quality of life (QOL) [ Time Frame: Change at 6 months from baseline ]
    QOL-Alzheimer's disease (sum, rage 0-52) / Higher scores mean better QOL.

  8. Change of activities of daily livings (ADL) [ Time Frame: Change at 6 months from baseline ]
    Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL.

  9. Change of nutritional status [ Time Frame: Change at 6 months from baseline ]
    Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition.

  10. Change of nutrition [ Time Frame: Change at 6 months from baseline ]
    Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition.

  11. Change of balance [ Time Frame: Change at 6 months from baseline ]
    Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function.

  12. Change of physical activity [ Time Frame: Change at 6 months from baseline ]
    Global Physical Activity Questionnaire (This is not scoring.)

  13. Change of motivation [ Time Frame: Change at 6 months from baseline ]

    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.


  14. Adverse event (number of participants) [ Time Frame: Up to 24 weeks ]
    adverse event in each group


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   60 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Inha Univeristy Hospital
Incheon, Korea, Republic of, 400-711
Dong-A University Hospital
Pusan, Korea, Republic of
Bobath Memorial Hospital
Seongnam, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
Inha University Hospital
Korea Health Industry Development Institute
Investigators
Layout table for investigator information
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
Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date March 4, 2021
Actual Study Start Date  ICMJE May 29, 2019
Actual Primary Completion Date February 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2019)
  • retention rate (percent) of the participants [ Time Frame: 6 months ]
    Retention rate in each intervention group
  • compliance (percent) [ Time Frame: 6 months ]
    Compliance to the protocol in each intervention group
  • Change of cognition [ Time Frame: Change at 6 months from baseline ]
    Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • retention rate (percent) of the participnats [ Time Frame: 6 months ]
    Retention rate in each intervention group
  • compliance (percent) [ Time Frame: 6 months ]
    Compliance to the protocol in each intervention group
  • Change of cognition [ Time Frame: Change at 6 months from baseline ]
    Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Change of global cognition [ Time Frame: Change at 6 months from baseline ]
    Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition.
  • Change of function [ Time Frame: Change at 6 months from baseline ]
    Clinical Dementia Rating scale-Sum of Boxes (sum, range 0-18) / Higher scores mean worse function.
  • Change of depression [ Time Frame: Change at 6 months from baseline ]
    Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion.
  • Change of subjective memory complaints [ Time Frame: Change at 6 months from baseline ]
    Prospective and Retrospective Memory Questionnaire (sum, range 18-80) / Higher scores mean worse memory.
  • Change of memory complaints [ Time Frame: Change at 6 months from baseline ]
    Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory.
  • Change of prospective memory [ Time Frame: Change at 6 months from baseline ]
    Prospective Memory test (sum, range 0-12) / Higher scores mean better memory.
  • Change of Quality of life (QOL) [ Time Frame: Change at 6 months from baseline ]
    QOL-Alzheimer's disease (sum, rage 0-52) / Higher scores mean better QOL.
  • Change of activities of daily livings (ADL) [ Time Frame: Change at 6 months from baseline ]
    Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL.
  • Change of nutritional status [ Time Frame: Change at 6 months from baseline ]
    Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition.
  • Change of nutrition [ Time Frame: Change at 6 months from baseline ]
    Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition.
  • Change of balance [ Time Frame: Change at 6 months from baseline ]
    Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function.
  • Change of physical activity [ Time Frame: Change at 6 months from baseline ]
    Global Physical Activity Questionnaire (This is not scoring.)
  • Change of motivation [ Time Frame: Change at 6 months from baseline ]
    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) [ Time Frame: Up to 24 weeks ]
    adverse event in each group
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description:
Independent raters are blinded to the group of participants.
Primary Purpose: Prevention
Condition  ICMJE
  • Mild Cognitive Impairment
  • Aged
Intervention  ICMJE Other: Multidomain intervention program
Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation
Study Arms  ICMJE
  • 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).
    Intervention: Other: Multidomain intervention program
  • 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.
    Intervention: Other: Multidomain intervention program
  • No Intervention: Controls
    They are waiting list controls. They will receive the multi-domain intervention after this study.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2021) 		152
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2019) 		150
Actual Study Completion Date  ICMJE February 25, 2020
Actual Primary Completion Date February 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03980392
Other Study ID Numbers  ICMJE HI18C0479
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We will decide it later.
Responsible Party Inha University Hospital
Study Sponsor  ICMJE Inha University Hospital
Collaborators  ICMJE Korea Health Industry Development Institute
Investigators  ICMJE
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
PRS Account Inha University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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