Patients With Mild Cognitive Impairment (MCI)NCT06355973
A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment
A study testing Using tablets and workbooks cognitive function. and self-programming of physical function training. in people with Patients With Mild Cognitive Impairment (MCI), run by MinYoung Kim, MD, PhD.
Trial summary
This is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment. It is for the prevention and treatment of dementia in the future. randomized, Pilot Study. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Patients With Mild Cognitive Impairment (MCI)
- What is being tested?
- Using tablets and workbooks cognitive function. and self-programming of physical function training.
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women aged 60 or older
- A person who falls within the abnormal range of the Montreal Cognitive Assessment (MoCA) test
- a person who can independently carry out daily life
- If the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical study
Who cannot join
- A person diagnosed with Alzheimer's dementia or other causes (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
- A person with unstable cardiovascular system, digestive system, respiratory system, endocrine system, etc. and poor general condition
- Patients who have participated in other treatment clinical studies or who have participated in other treatment clinical studies within the last 30 days
- Other cases where the researcher determines that participation in this clinical study is not appropriate
Trial locations and contacts
No sites are listed yet.
About this study
This is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment.
It is for the prevention and treatment of dementia in the future. randomized, Pilot Study.
- Being tested
- Using tablets and workbooks cognitive function., self-programming of physical function training.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using tablets and workbooks cognitive function.Device
Cognitive training programs corresponding to memory, attention, time and space, and orientation are conducted for 35 to 60 minutes.
self-programming of physical function training.Device
The fitness program consisting of stretching, muscle strength, coordination, and aerobic exercise lasts 20 to 30 minutes, and additional 3-4 times/mainly 30 to 40 minutes of aerobic exercise.
| Study group | Role | What they receive |
|---|---|---|
| Using tablets and workbooks. | Experimental | Using tablets and workbooks Cognitive and physical function training self-programming for 6 weeks. Receives: Device: Using tablets and workbooks cognitive function.; Device: self-programming of physical function training. |
| Only self-programming of physical function training. | Experimental | Only self-programming of physical function training is provided Implemented for 6 weeks. Receives: Device: self-programming of physical function training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
K-MoCA is a measure of memory loss or other symptoms of cognitive decline. It includes 30 questions and a task that takes about 12 minutes to complete. The score can range from 0 to 30. A score of 26 or higher is considered normal.
Measured: screening - 6 weeks - 3 months
Secondary outcomes (9)
Korean-Mini Mental Status Examination (K-MMSE)
K-MMSE is a measurement of cognitive level. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe(≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.
Measured: Baseline - 6 weeks - 3months
Clinical Dementia Rating (CDR)
CDR is a rating scale for staging patients diagnosed with dementia. The CDR evaluates cognitive, behavioral and functional aspects of Alzheimer disease and other dementias. It is calculated on the basis of testing six different cognitive and behavioral domains such as memory, orientation, judgment and problem solving, community affairs, home and hobbies performance, and personal care. The CDR is based on a scale of 0-3: no dementia (CDR = 0), questionable dementia (CDR = 0.5), MCI (CDR = 1), moderate cognitive impairment (CDR = 2) and severe cognitive impairment (CDR = 3)
Measured: Baseline - 3months
Clinical Global Impressions of Change (CGIC)
CGIC is a commonly used measure to measure the severity, treatment rate, and treatment effectiveness of symptoms in the treatment process or research of patients with mental illness.
Measured: Baseline - 6 weeks- 3months
Instrumental Activities of Daily Living (I-ADL)
I-ADL consists of skills and behaviors necessary for social life such as "money management," "households," "phone use," and "drugs," and helps evaluate the degree of social and professional functioning of the elderly with dementia.
Measured: Baseline - 6 weeks- 3months
Berg Balance Scale (BBS)
BBS is a measurement of balancing function. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total score = 56
Measured: Baseline - 6 weeks- 3months
Geriatric Quality of Life-Dementia (GQOL-D)
GQOL-D is a tool for evaluating the quality of life of the elderly with dementia and consists of a four-point scale of 15 items, including 13 items that measure physical health, psychological health, social relationships and environment, and two items that measure overall health and life satisfaction.
Measured: Baseline - 6 weeks- 3months
Geriatric Depression Scale (GDSd)
GDS is a 30-item self-report assessment used to identify depression in the elderly. One point is assigned to each answer and the cumulative score is rated on a scoring grid. The grid sets a range of 0-9 as "normal", "10-19" as "mildly depressed", and 20-30 as "severely depressed".
Measured: Baseline - 6 weeks- 3months
Global Deterioration Scale (GDS)
GDS is one of the representative rating scales that suggests the severity of dementia patients and is used as a useful test tool for clinical trials of dementia treatments and early diagnosis of dementia.
Measured: Baseline - 3months
Electroencephalography
EEG is a measurement of electrical activity in the brain using small electrodes attached to the scalp for diagnose brain disorders.
Measured: Baseline - 6 weeks- 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study startApr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Mild Cognitive Impairment (MCI)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MinYoung Kim, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
- Investigators
- MinYoung Kim, MD, PhD, Principal investigator, CHA Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355973
- Sponsor's protocol ID
- 2024-01-061
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06355973
- Acronym / sponsor ID
- 2024-01-061
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- MinYoung Kim, MD, PhDUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Apr 2024 (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 is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment.
It is for the prevention and treatment of dementia in the future. randomized, Pilot Study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using tablets and workbooks. | Experimental | Device: Using tablets and workbooks cognitive function., Device: self-programming of physical function training.Using tablets and workbooks Cognitive and physical function training self-programming for 6 weeks. |
| Only self-programming of physical function training. | Experimental | Device: self-programming of physical function training.Only self-programming of physical function training is provided Implemented for 6 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women aged 60 or older
- A person who falls within the abnormal range of the Montreal Cognitive Assessment (MoCA) test
- a person who can independently carry out daily life
- If the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical study
Key exclusion criteria (4 listed)
- A person diagnosed with Alzheimer's dementia or other causes (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
- A person with unstable cardiovascular system, digestive system, respiratory system, endocrine system, etc. and poor general condition
- Patients who have participated in other treatment clinical studies or who have participated in other treatment clinical studies within the last 30 days
- Other cases where the researcher determines that participation in this clinical study is not appropriate
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 |
|---|---|---|
| Using tablets and workbooks cognitive function.Cognitive training programs corresponding to memory, attention, time and space, and orientation are conducted for 35 to 60 minutes. | Device | Using tablets and workbooks. |
| self-programming of physical function training.The fitness program consisting of stretching, muscle strength, coordination, and aerobic exercise lasts 20 to 30 minutes, and additional 3-4 times/mainly 30 to 40 minutes of aerobic exercise. | Device | Only self-programming of physical function training., Using tablets and workbooks. |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: screening - 6 weeks - 3 months
K-MoCA is a measure of memory loss or other symptoms of cognitive decline. It includes 30 questions and a task that takes about 12 minutes to complete. The score can range from 0 to 30. A score of 26 or higher is considered normal.
9 secondary outcomes
Korean-Mini Mental Status Examination (K-MMSE)
Time frame: Baseline - 6 weeks - 3months
Clinical Dementia Rating (CDR)
Time frame: Baseline - 3months
Clinical Global Impressions of Change (CGIC)
Time frame: Baseline - 6 weeks- 3months
Instrumental Activities of Daily Living (I-ADL)
Time frame: Baseline - 6 weeks- 3months
Berg Balance Scale (BBS)
Time frame: Baseline - 6 weeks- 3months
Geriatric Quality of Life-Dementia (GQOL-D)
Time frame: Baseline - 6 weeks- 3months
Geriatric Depression Scale (GDSd)
Time frame: Baseline - 6 weeks- 3months
Global Deterioration Scale (GDS)
Time frame: Baseline - 3months
Electroencephalography
Time frame: Baseline - 6 weeks- 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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.
MinYoung Kim, MD, PhD principal investigator
CHA Bundang Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Using tablets and workbooks cognitive function. and self-programming of physical function training. in people with Patients With Mild Cognitive Impairment (MCI), run by MinYoung Kim, MD, PhD.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MinYoung Kim, MD, PhD (+82317806281, kmin@cha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: screening - 6 weeks - 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2024.