Effect of Cognitive and Physical Function Training in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- K-MMSE (Korean Mini-Mental Status Examination)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 65 years or older.
- •Individuals capable of independent daily living (including mobility).
- •Individuals who fully understand the study and voluntarily agree to participate, providing written consent.
排除标准
- •MMSE score less than 20 (19 or below will be excluded).
- •Individuals with neurological conditions such as stroke, brain tumor, cerebral palsy, dementia, or Parkinson's disease.
- •Individuals with serious medical conditions (cardiovascular, gastrointestinal, respiratory, endocrine, etc.) that compromise their general health.
- •Participants currently involved in other clinical studies or who participated in another clinical trial within the past 30 days.
- •Any other conditions deemed inappropriate for study participation by the researcher.
研究组 & 干预措施
Intervention
Intensive cognitive and physical training
干预措施: Intensive cognitive and physical training (Other)
结局指标
主要结局
K-MMSE (Korean Mini-Mental Status Examination)
时间窗: 4 weeks
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.
次要结局
- RBANS (Repeatable Battery for the Assessment of Neuropsychological Status)(4 weeks)
- K-MBI (Korean Version of the Modified Barthel Index)(4 weeks)
- BBS (Berg Balance Scale)(4 weeks)
研究者
MinYoung Kim, MD, PhD
Prof
Bundang CHA Hospital