Evaluation of the Effect of Cognitive and Physical Training on Mild Cognitive Impairment Elder's Physical and Cognition Domain: A Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 主要终点
- Chair sit-and-reach test
研究概览
简要总结
This study examines the impact of combining cognitive and physical training, recognizing that daily living often requires individuals to perform multiple tasks simultaneously. The inability to execute such dual movements can hinder daily functioning.
The primary goal is to enhance the ability of individuals with mild cognitive impairment (MCI) to perform two tasks concurrently, focusing on both cognitive and physical aspects. This research aims to deepen our understanding of how multitasking affects patients' abilities and to develop effective intervention programs.
详细描述
The World Health Organization has recognized cognitive impairment as a significant global health issue, encompassing a spectrum of conditions from mild cognitive impairment to various forms of dementia. These conditions are linked to heightened risks of disability and mortality. In the absence of suitable interventions, cognitive functions typically exhibit a gradual decline over time, driven by factors including aging, neurological disorders, traumatic brain injury, and substance abuse.
A thorough literature review indicates that cognitive and physical training can sustain cognitive or physical functions, contingent upon the specific training protocols implemented. Concurrent cognitive and physical training entails the simultaneous execution of multiple cognitive and motor activities, thereby maintaining dual functional control. This innovative training modality integrates motor and cognitive rehabilitation into a cohesive framework.
This clinical trial adopts a randomized controlled design, stratifying participants into four distinct groups: cognitive training, physical training, combined cognitive and physical training, and passive informational activities. The interventions will be administered with a frequency of three times per week over a 12-week period, incorporating task-specific training to enhance both motor and cognitive functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be aged 60 years or older and able to communicate in Mandarin or Taiwanese.
- •Mild cognitive impairment, assessed using the Mini Mental State Examination (MMSE) with a score of 14≦MMSE≦
- •Self-reported complaints of cognitive decline.
- •In addition to the above criteria, participants must voluntarily agree to participate and sign an informed consent form.
排除标准
- •Individuals with severe psychiatric disorders or behavioral problems, as assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) with (a) severity score ≥ 6 and caregiver distress score ≥
- •Participants who have undergone other cognitive or activity training within the past six months.
- •Individuals with sensory impairments, such as visual, auditory, or communication difficulties.
- •People with mobility impairments, such as those who use wheelchairs or mobility aids.
结局指标
主要结局
Chair sit-and-reach test
时间窗: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
A flexibility test.
Digit Span Test
时间窗: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
A standardized instrument for assessing working memory.
Mini-Mental State Examination
时间窗: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
The Mini-Mental State Examination (MMSE) is a standardized instrument for assessing overall cognitive function, where higher scores indicate better global cognition, with a total score ranging from 0 to 30. It is crucial to consider both age and education levels when interpreting the results.
Wisconsin Card Sorting Test - Computer Version
时间窗: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
The Wisconsin Card Sorting Test (WCST) is a standardized instrument for assessing executive function. Interpreting WCST results includes analyzing the total correct responses and total errors. The total correct responses indicate the number of correct matches made by the participant; a higher number of correct responses suggests better overall cognitive performance and the ability to learn and apply the rules. Conversely, a high number of errors can indicate difficulties in understanding or applying the sorting rules.
Shor-form Berg balance scale
时间窗: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
The Short-Form Berg Balance Scale (SFBBS) is a streamlined assessment tool designed to evaluate an individual's balance and stability. Each item on the SFBBS is scored on a scale from 0 to 4, with 0 indicating the lowest level of function and 4 indicating the highest level of function. The scores for each item are summed to obtain a total score, which provides an overall measure of balance. The maximum possible score varies depending on the number of items included in the short form.
Back scratch test
时间窗: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
A flexibility test.
Gait analysis
时间窗: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
A standardized instrument " PABLO®" for assessing gait performance.
Grip and pinch strength
时间窗: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
A standardized instrument " PABLO®" for assessing strength.
次要结局
- Actigraphy sleep efficiency (%)(Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention)
- Insomnia Severity Index(Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention)
- Actigraphy sleep onset latency (minutes)(Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention)
- Actigraphy sleep fragmentation (%)(Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention)
- Pittsburgh Sleep Quality Index(Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention)
- Actigraphy total sleep time (minutes)(Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention)
- Actigraphy wake duration (minutes)(Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention)
- Actigraphy time in bed (minutes)(Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention)
研究者
Jia-You, YE
Principal Investigator
Taipei Medical University