Effects and Mechanism of Two Hybrid Exercise-cognitive Trainings in Mild Ischemic Stroke With Cognitive Decline: fMRI for Brain Plasticity, and Biomarker and Behavioral Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- fMRI (change is being assessed)
研究概览
简要总结
The purposes are to: (1) examine and compare the effects of two hybrid interventions on brain plasticity, physiological biomarkers and behavioral outcomes, including cognitive and physical functions, from pre- to post-training; (2) understand the neural mechanisms of cognitive recovery following two hybrid interventions using the functional magnetic resonance imaging (fMRI); (3) examine the long-term benefits of the two hybrid therapies; (4) to identify the correlations between brain activity, biomarkers and behavioral measures.
详细描述
Cognitive decline after stroke is highly associated with functional disability. Empirical evidence shows that exercise combined cognitive training may induce neuroplastic changes that modulate cognitive function. However, it is unclear whether hybridized exercise-cognitive trainings can facilitate cortical activity and physiological outcome measures and further influence on the cognitive function after stroke. We aim to investigate the effects of two hybridized exercise-cognitive trainings on brain plasticity, physiological biomarkers and behavioral outcomes in stroke survivors with cognitive decline. This study is a single-blind randomized controlled trial. A target sample size of 75 participants will be recruited. Stroke survivors with mild cognitive decline will be stratified by Mini-Mental State Examination scores and then randomized 1:1:1 to sequential exercise-cognitive training, dual-task exercise-cognitive training or control groups. All groups will undergo trainings 60 min/day, 3 days/week, for a total of 12 weeks. The primary outcome is the resting-state functional connectivity and neural activation in the frontal, parietal and occipital lobes in functional magnetic resonance imaging. Secondary outcomes include physiological biomarkers, cognitive functions, physical function, daily functions and quality of life.
This study may differentiate the effects of two hybridized trainings on cognitive function and health-related conditions and detect appropriate neurological and physiological indices to predict training effects. This study capitalizes on the groundwork for non-pharmacological intervention of cognitive decline after stroke.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke occurring at least 6 months prior to enrollment
- •Age range from 20 to 80 years
- •MMSE score < 28 or MoCA<25
- •Able to follow the study instruction
- •Adequate cardiopulmonary function to perform aerobic exercise
- •Able to walk with or without assistive devices
排除标准
- •Unstable medical history (e.g., recent myocardial infarction) that might limit participation
- •Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
- •Current participation in another interventional trial
- •Any contraindication to MRI (metallic implants, claustrophobia, seizure, pacemakers, et al)
- •Pregnant woman
研究组 & 干预措施
Sequential training group
Exercise training for 30 minutes followed by 30 minutes of cognitive-based intervention
干预措施: Sequential training (Behavioral)
Dual training group
Exercise training simultaneously combined cognitive-based intervention for 60 minutes
干预措施: Dual training (Behavioral)
Control training group
non-aerobic exercise (e.g., stretch, range of motion exercise...) and unstructured cognitive rehabilitation programs (e.g., reading newspapers, playing board games...) for 60 minutes
干预措施: Control training (Behavioral)
结局指标
主要结局
fMRI (change is being assessed)
时间窗: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months).
Resting-state functional connectivity and neural activation in the frontal, parietal and occipital lobes
次要结局
- Dual-task test(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Stroke Impact Scale (SIS)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Caregiver Burden Scale (CB scale)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- EuroQol-5D questionnaire (EQ-5D)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Serum BDNF level(Baseline, posttest (an expected average of 3 months))
- Wechsler Memory Scale - Third Edition (WMS-III)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Functional Independence Measure (FIM)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Useful Field of View (UFOV)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Stroop Color-Word test(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Six-minute walk test (6MWT)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- International Physical Activity Questionnaires (IPAQ)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Lawton Instrumental Activities of Daily Living Scale (Lawton LADL)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Montreal Cognitive Assessment (MoCA)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Antioxidative marker(Baseline, posttest (an expected average of 3 months)])
- Glucose indicator(Baseline, posttest (an expected average of 3 months))
- Plasma lipid level(Baseline, posttest (an expected average of 3 months))
- Time up and go test (TUG)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Fugl-Meyer Assessment (FMA)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Rivermead Mobility Index (RMI)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Muscle strength(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Mobility level(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))