A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment

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 Overview

• Status: Not yet recruiting
• Conditions: Patients With Mild Cognitive Impairment (MCI)
• Intervention / Treatment: Device: Using tablets and workbooks cognitive function.; Device: self-programming of physical function training.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MinYoung Kim, MD, PhD; Phone Number: +82317806281; Email: kmin@cha.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. men and women aged 60 or older
2. A person who falls within the abnormal range of the Montreal Cognitive Assessment (MoCA) test
3. a person who can independently carry out daily life
4. 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

Exclusion Criteria:

1. A person diagnosed with Alzheimer's dementia or other causes (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
2. A person with unstable cardiovascular system, digestive system, respiratory system, endocrine system, etc. and poor general condition
3. Patients who have participated in other treatment clinical studies or who have participated in other treatment clinical studies within the last 30 days
4. Other cases where the researcher determines that participation in this clinical study is not appropriate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Using tablets and workbooks.; Using tablets and workbooks Cognitive and physical function training self-programming for 6 weeks.	Device: 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: 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.
Experimental: Only self-programming of physical function training.; Only self-programming of physical function training is provided Implemented for 6 weeks.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	screening - 6 weeks - 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	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.	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	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.	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".	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.	Baseline - 3months
Electroencephalography	EEG is a measurement of electrical activity in the brain using small electrodes attached to the scalp for diagnose brain disorders.	Baseline - 6 weeks- 3months

Collaborators and Investigators

• Sponsor: MinYoung Kim, MD, PhD
• Investigators: Principal Investigator: MinYoung Kim, MD, PhD, CHA Bundang Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2024-01-061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No