Feasibility Study of 'SuperBrain BOOM' for Mild Cognitive Impairment Patients
NCT ID: NCT07101380
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2025-10-15
2026-04-30
Brief Summary
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The main questions it aims to answer are:
Can SuperBrain BOOM be safely and effectively used by people with MCI? Does the program help improve cognitive and physical function? Do participants stay engaged and complete the program as expected?
Researchers will compare:
A mobile intervention group using SuperBrain BOOM (on tablet or smartphone) A control group receiving usual care
Participants will:
Use a tablet or smartphone to follow a personalized physical activity program for 12 weeks Complete clinical assessments on cognition, physical ability, mood, and nutrition Be monitored for safety and program adherence using automatically collected data
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Detailed Description
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Mild Cognitive Impairment is a condition in which individuals experience noticeable cognitive decline without significant impairment in daily functioning. It is considered a transitional stage between normal aging and dementia. Evidence suggests that regular physical activity and cognitive engagement can delay or reduce the risk of progression to dementia.
SuperBrain BOOM provides personalized exercise programs tailored to each participant's cognitive status, physical capacity, and lifestyle, and is designed to improve cognitive function, physical performance, emotional well-being, and quality of life.
This randomized controlled trial will allocate participants into three groups: a mobile intervention group (tablet or smartphone) and a control group receiving usual care. The primary outcomes include changes in cognitive function, physical performance, mood, nutritional status, and quality of life over 12 weeks. Safety and adherence will be monitored throughout the intervention using system-generated data and clinical assessments.
Secondary analyses will explore subgroup differences based on APOE genotype and demographic variables to better understand who benefits most from the intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Tablet-based intervention group
Tablet-based Physical SuperBrain BOOM
This intervention is a tablet-based physical activity program designed for patients with Mild Cognitive Impairment (MCI).
Participants receive a personalized exercise plan through a tablet application, with real-time feedback to enhance cognitive function.
Compared to the smartphone-based version, this program is designed to provide a larger interface and structured environment, allowing participants to engage in the program using a tablet at home or in a clinical setting.
The app also helps track progress and encourage adherence to the exercise regimen.
Smartphone-based intervention group
Smartphone-based SuperBrain BOOM
This intervention is a smartphone-based physical activity program designed for MCI patients. Participants receive a personalized exercise plan through a smartphone app, with real-time feedback to enhance cognitive function. Unlike the tablet-based intervention, this program is designed to be more portable and flexible, enabling participants to engage in the program from anywhere using their smartphones. The app also helps track progress and encourage adherence to the exercise regimen.
Control group
No interventions assigned to this group
Interventions
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Tablet-based Physical SuperBrain BOOM
This intervention is a tablet-based physical activity program designed for patients with Mild Cognitive Impairment (MCI).
Participants receive a personalized exercise plan through a tablet application, with real-time feedback to enhance cognitive function.
Compared to the smartphone-based version, this program is designed to provide a larger interface and structured environment, allowing participants to engage in the program using a tablet at home or in a clinical setting.
The app also helps track progress and encourage adherence to the exercise regimen.
Smartphone-based SuperBrain BOOM
This intervention is a smartphone-based physical activity program designed for MCI patients. Participants receive a personalized exercise plan through a smartphone app, with real-time feedback to enhance cognitive function. Unlike the tablet-based intervention, this program is designed to be more portable and flexible, enabling participants to engage in the program from anywhere using their smartphones. The app also helps track progress and encourage adherence to the exercise regimen.
Eligibility Criteria
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Inclusion Criteria
2. Meets all of the core clinical criteria for suspected Mild Cognitive Impairment (MCI) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines as of the screening date:
* Concerns of the participant or caregiver regarding cognitive decline compared to prior functioning.
* Impairment in at least one cognitive domain.
* Preserved independence in overall daily living activities.
* No dementia.
3. Has one or more of the following neuropsychological test results within one year of the screening date, with delayed recall scores in the memory domain below the mean -1.0 standard deviation according to age- and education-adjusted normative data:
* Seoul Neuropsychological Screening Battery 2nd Edition (SNSB-II)
* Korean version of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD-K)
* Literacy Independent Cognitive Assessment (LICA)
4. As of the screening date, has a Korea-Mini Mental State Examination (K-MMSE-2) score that corresponds to at least -1.5 standard deviations below the mean based on age- and education-adjusted normative data.
5. As of the screening date, has a Global Clinical Dementia Rating (CDR) score of 0.5, with a memory score of either 0.5 or 1.
6. Capable of using a tablet or smartphone with training, or has a research partner who can assist with using a tablet or smartphone.
7. Has a caregiver who regularly contacts the participant:
-A caregiver who is able to support the participant (monitor compliance and report participant status) and spends at least 8 hours per week with the participant during the trial period.
8. The participant provides written informed consent to participate in the study.
Exclusion Criteria
2. Dementia.
3. Other neurodegenerative diseases, such as Parkinson's disease.
4. Malignant tumors within the past 5 years that have not been declared cured.
5. Vascular surgery or stent placement within the past year.
6. Severe or unstable symptomatic cardiovascular disease.
7. Evidence of severe or unstable physical conditions, such as acute or severe asthma, active peptic ulcers, severe liver disease, kidney disease requiring dialysis, or any other medical conditions that may interfere with completing the clinical trial.
8. Severe vision impairment, severe hearing loss, or communication difficulties that would prevent the participant from undergoing the intervention or efficacy assessments.
9. Abnormal findings in clinical pathology tests related to cognitive decline, as determined by the clinical investigator (e.g., significant thyroid dysfunction, vitamin B12 or folate deficiency, neurosyphilis, etc.).
10. The investigator's judgment that the participant is unlikely to cooperate fully with the study.
11. The investigator's judgment that the participant has difficulty safely participating in an exercise-based intervention program.
12. Participation in another interventional clinical trial.
50 Years
85 Years
ALL
No
Sponsors
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Ajou University School of Medicine
OTHER
Responsible Party
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So Young Moon
Professor
Principal Investigators
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So Young Moon
Role: PRINCIPAL_INVESTIGATOR
Ajou University School of Medicine
Locations
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Bundang CHA General Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Pusan National University Hospital
Busan, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Countries
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Central Contacts
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Daae Kim
Role: CONTACT
Facility Contacts
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Other Identifiers
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RS-2024-00337993
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AJOUIRB-DE-2025-36
Identifier Type: -
Identifier Source: org_study_id
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