Synergistic Effects of Combined Physical-cognitive Training on Cognitive Function in Individuals With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- change from baseline Alzheimer's Disease Assessment- cognitive subscale at 3 months
研究概览
简要总结
The present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. It is hypothesized that: 1) the combined physical-cognitive training program will be superior to the physical and cognitive training program alone; and 2) the degree of cognitive improvement will be positively correlated with the improvement of plasma BDNF and mitochondrial function.
详细描述
Recent research suggests that the benefits of combined physical-cognitive training may be greater than either physical or cognitive training alone. Nevertheless, this synergistic effect has been demonstrated mainly in cognitively intact older adults. Studies examining the effects of combined physical-cognitive training in older adults with MCI are scarce and show mixed results. Moreover, few studies have determined the effects of the combined training on peripheral brain-derived neurotrophic factor (BDNF) and mitochondrial function. Thus, the present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. The present study will provide insight into the interplay among the training program, peripheral BDNF concentration, mitochondrial function, and cognitive function. Importantly, the findings will have clinical implication regarding the training program that is feasible and effective in improving cognitive function of older adults with MCI which ultimately will have great impact on public health as this population is at high risk of progression to AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet criteria for mNCD (mild neurocognitive disorders), previously known as MCI, based on the recent DSM-V (Diagnostic Statistical Manual-V) criteria
- •comprehend instructions and willing to participate
- •able to comply with the study schedule and procedures
- •not taking any medications for their cognition and not planning to start medications during the study trial
排除标准
- •presence of medical conditions that would be unsafe to exercise
- •diagnosed with other neurological conditions (e.g. Parkinson's disease, Stroke, Multiple Sclerosis, AD) that affect cognition and mobility
- •presence of depressive symptoms
- •presence of acute or/and chronic disease that could not be controlled (e.g. Arthritis, Asthma, Hypertension, Diabetes mellitus, Coronary artery disease)
- •exercise regularly (at least 30 min/day, 3 days/week)
结局指标
主要结局
change from baseline Alzheimer's Disease Assessment- cognitive subscale at 3 months
时间窗: 3 months
Alzheimer's Disease Assessment-cognitive subscale will be assessed at baseline and 3 months. The total scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment.
change from baseline Rey auditory verbal learning score at 3 months
时间窗: 3 months
Memory will be assessed using Rey auditory verbal learning test.
change from baseline brain-derived neurotrophic factor level at 3 months
时间窗: 3 months
Level of plasma brain-derived neurotrophic factor (BDNF) will be determined.
change from baseline Trail Making B-A score at 3 months
时间窗: 3 months
Executive function will be assessed using Trail Making Test part B-A.
次要结局
- change from baseline stepping response time at 3 months(3 months)
- change from baseline time to complete Timed Up and Go at 3 months(3 months)
- change from baseline physiological profile assessment score at 3 months(3 months)
- change from baseline Digit Span score at 3 months(3 months)
- change from baseline cellular oxidative stress level at 3 months(3 months)
研究者
Somporn Sungkarat
Associate Professor
Chiang Mai University