Mild Cognitive ImpairmentSUPERBRAINNCT03980392
South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention
A study testing Multidomain intervention program in people with Mild Cognitive Impairment and Aged, run by Inha University Hospital at 6 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Aged
- What is being tested?
- Multidomain intervention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 29 May 2019to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60-79
- Having at least one among the following dementia risks,
- hypertension
- Diabetes Mellitus
- Dyslipidemia
- Obesity
Show all 17Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Chonnam National University Hospital
Gwangju
Inha Univeristy Hospital
Incheon, 400-711
Dong-A University Hospital
Pusan
Bobath Memorial Hospital
Seongnam
Ewha Womans University Mokdong Hospital
Seoul
Ajou University Hospital
Suwon
About this study
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
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Aged
- Being tested
- Multidomain intervention program
- Keywords
- prevention, dementia, intervention, mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain intervention programOther
Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation
| Study group | Role | What they receive |
|---|---|---|
| Facility-based Intervention | Experimental | 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). Receives: Other: Multidomain intervention program |
| Home-based Intervention | Experimental | 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. Receives: Other: Multidomain intervention program |
| Controls | No intervention | They are waiting list controls. They will receive the multi-domain intervention after this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention rate (percent) of the participants
Retention rate in each intervention group
Measured: 6 months
compliance (percent)
Compliance to the protocol in each intervention group
Measured: 6 months
Change of cognition
Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.
Measured: Change at 6 months from baseline
Secondary outcomes (14)
Change of global cognition
Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition.
Measured: 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.
Measured: Change at 6 months from baseline
Change of depression
Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion.
Measured: 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.
Measured: Change at 6 months from baseline
Change of memory complaints
Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory.
Measured: Change at 6 months from baseline
Change of prospective memory
Prospective Memory test (sum, range 0-12) / Higher scores mean better memory.
Measured: 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.
Measured: Change at 6 months from baseline
Change of activities of daily livings (ADL)
Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL.
Measured: Change at 6 months from baseline
Change of nutritional status
Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition.
Measured: Change at 6 months from baseline
Change of nutrition
Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition.
Measured: Change at 6 months from baseline
Change of balance
Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function.
Measured: Change at 6 months from baseline
Change of physical activity
Global Physical Activity Questionnaire (This is not scoring.)
Measured: 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.
Measured: Change at 6 months from baseline
Adverse event (number of participants)
adverse event in each group
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start29 May 2019
- Primary completion14 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Sponsor-investigator, Inha University Hospital, Inha University Hospital
- Investigators
- Jee Hyang Jeong, MD, PhD, Principal investigator, Ewha Womans University HospitalSo Young Moon, MD, PhD, Principal investigator, Ajou University Hospital, NeurologyChang Hyung Hong, MD, PhD, Principal investigator, Ajou University Hospital, PsychiatryHae Ri Na, MD, PhD, Principal investigator, Bobath Memorial HospitalKyung Won Park, MD, PhD, Principal investigator, Dong-A University HospitalByung Chae Kim, MD, PhD, Principal investigator, Chonnam National University HospitalYoo Kyoung Park, PhD, Study director, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980392
- Sponsor's protocol ID
- HI18C0479
- Acronym
- SUPERBRAIN
- Status last verified
- Mar 2021
- First submitted
- 28 May 2019
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will decide it later.
Publications
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.
PubMed 36805537Park 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.
PubMed 36313025
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03980392
- Acronym / sponsor ID
- SUPERBRAIN / HI18C0479
- Conditions
- Mild Cognitive Impairment, Aged
- Keywords
- prevention, dementia, intervention, mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- 29 May 2019 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Facility-based Intervention | Experimental | Other: Multidomain intervention programA 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). |
| Home-based Intervention | Experimental | Other: Multidomain intervention programThe 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. |
| Controls | No intervention | –They are waiting list controls. They will receive the multi-domain intervention after this study. |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Aged 60-79
- Having at least one among the following dementia risks,
- 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
Key exclusion criteria (13 listed)
- Major psychiatric illness such as major depressive disorders
- Dementia
- Substantial cognitive decline
- Other degenerative disease (e.g., Parkinson's disease)
- Malignancy within 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidomain intervention programMultidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation | Other | Facility-based Intervention, Home-based Intervention |
Primary outcome
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.
14 secondary outcomes
Change of global cognition
Time frame: Change at 6 months from baseline
Change of function
Time frame: Change at 6 months from baseline
Change of depression
Time frame: Change at 6 months from baseline
Change of subjective memory complaints
Time frame: Change at 6 months from baseline
Change of memory complaints
Time frame: Change at 6 months from baseline
Change of prospective memory
Time frame: Change at 6 months from baseline
Change of Quality of life (QOL)
Time frame: Change at 6 months from baseline
Change of activities of daily livings (ADL)
Time frame: Change at 6 months from baseline
Change of nutritional status
Time frame: Change at 6 months from baseline
Change of nutrition
Time frame: Change at 6 months from baseline
Change of balance
Time frame: Change at 6 months from baseline
Change of physical activity
Time frame: Change at 6 months from baseline
Change of motivation
Time frame: Change at 6 months from baseline
Adverse event (number of participants)
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Derived from this study: PubMed 36805537Han 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.
- Derived from this study: PubMed 36313025Park 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.
- Individual participant dataSharing planned: No. We will decide it later.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jee Hyang Jeong, MD, PhD principal investigator
Ewha Womans University Hospital
So Young Moon, MD, PhD principal investigator
Ajou University Hospital, Neurology
Chang Hyung Hong, MD, PhD principal investigator
Ajou University Hospital, Psychiatry
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain intervention program in people with Mild Cognitive Impairment and Aged, run by Inha University Hospital at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retention rate (percent) of the participants (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03980392, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.