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| Name | Class |
|---|---|
| Ministry of Science and ICT, Republic of Korea | OTHER_GOV |
| The Korea Health Technology R&D Project through the Korea Health Industry Development Institute | UNKNOWN |
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This is a single-arm intervention study aimed at investigating whether a 4-week program of daily cognitive and physical activities, lasting 2-3 hours per day, produces significant changes in functional levels in healthy adults aged 65 and older.
Purpose of the Clinical Study The aim of this clinical study is to evaluate the effects of cognitive and physical function training in elderly individuals (including those with subjective cognitive decline) to aid in the development of preventive and therapeutic methods for dementia.
Study Participants -Number of Participants and Basis This is a pilot study, and no formal sample size calculation was performed. The study will include 30 participants.
Clinical Study Procedure and Assessment Visit 1 (Screening) During the screening visit, the researcher will select participants based on the inclusion/exclusion criteria. All study-related assessments will take place after obtaining consent. However, if any assessments were performed within 7 days of the screening visit, those results may be used instead. The following activities will be conducted:
Visit 2 (Baseline Assessment) Baseline assessments will be conducted, and Visit 1 and Visit 2 can be performed on the same day. The following activities will be conducted:
After the baseline assessment, participants will receive self-training materials for a 4-week program, jointly developed by EBS (Korea Educational Broadcasting System) and Bundang CHA Hospital. The cognitive and physical function training program will be conducted five times a week for 40 minutes per session. The effectiveness will be evaluated through baseline assessments, and post-training assessments will be conducted after 4 weeks to analyze the results.
The cognitive and physical training program consists of 25-35 minutes of cognitive training (memory, attention, visuospatial orientation) and 10-15 minutes of physical training (stretching, strength training, coordination, and aerobic exercise). Additionally, participants will be instructed to perform 30-40 minutes of aerobic exercise 3-4 times per week.
Participants will be provided with a self-training log to record whether they performed the exercise and to check adherence.
Visit 3 (Post-training Assessment) After completing the 4-week cognitive and physical training program, post-training assessments will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intensive cognitive and physical training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive cognitive and physical training | Other | The cognitive and physical training program consists of 25-35 minutes of cognitive training (memory, attention, visuospatial orientation) and 10-15 minutes of physical training (stretching, strength training, coordination, and aerobic exercise). Additionally, participants will be instructed to perform 30-40 minutes of aerobic exercise 3-4 times per week |
| Measure | Description | Time Frame |
|---|---|---|
| K-MMSE (Korean Mini-Mental Status Examination) | The Mini-Mental State Examination (MMSE) is a widely used screening tool for assessing cognitive function. It is designed to evaluate different cognitive abilities, including memory, attention, language, orientation, and visuospatial skills. The MMSE consists of a series of questions and tasks, with a maximum score of 30 points. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a neuropsychological test battery used to evaluate cognitive functioning across multiple domains. It is often employed to assess cognitive decline, dementia, and other conditions that affect memory and cognition. RBANS is designed to be both comprehensive and time-efficient, typically taking around 20-30 minutes to administer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | 13609 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42143241 | Derived | Shin S, Lim I, Baik H, Park E, Hong JM, Kim JM, Kim M. Feasibility of a short-term intensive home-based cognitive and physical training program for older adults: a single-arm pilot study. BMC Geriatr. 2026 May 16. doi: 10.1186/s12877-026-07655-9. Online ahead of print. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 4 weeks |
| K-MBI (Korean Version of the Modified Barthel Index) | The Modified Barthel Index (MBI) is a widely used tool to measure a person's ability to perform activities of daily living (ADL) independently. It assesses functional mobility and self-care tasks, which are essential for independent living. The MBI is an adaptation of the original Barthel Index and is commonly used in rehabilitation settings to evaluate the progress of patients recovering from conditions such as stroke, brain injuries, or other impairments that affect physical function. | 4 weeks |
| BBS (Berg Balance Scale) | The Berg Balance Scale (BBS) is a clinical test used to measure balance and assess the risk of falling in individuals, particularly older adults or those with neurological conditions. The test consists of 14 tasks that evaluate both static and dynamic balance, such as standing, sitting, and moving between positions. Each task is scored on a scale from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance and lower fall risk. | 4 weeks |