Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 12
- 主要终点
- Change scores of Stroop Color-Word test
研究概览
简要总结
The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline. The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
- •Age range from 20 to 90 years
- •MMSE score ≥ 19
- •Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
- •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
结局指标
主要结局
Change scores of Stroop Color-Word test
时间窗: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Montreal Cognitive Assessment (MoCA)
时间窗: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
时间窗: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
时间窗: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Useful Field of View (UFOV)
时间窗: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Dual-task test
时间窗: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.
次要结局
- Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of EuroQol (EQ)-5D questionnaire(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of Rivermead Mobility Index (RMI)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of Plasma lipid level(Baseline, posttest (an expected average of 3 months))
- Change scores of serum BDNF level(Baseline, posttest (an expected average of 3 months))
- Change scores of Antioxidative marker(Baseline, posttest (an expected average of 3 months))
- Change scores of Caregiver Burden (CB) scale(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of Functional Independence Measure (FIM)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of Mobility level(Baseline, posttest (an expected average of 3 months))
- Change scores of International Physical Activity Questionnaires (IPAQ)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of Glucose indicator(Baseline, posttest (an expected average of 3 months))
- Change scores of Fugl-Meyer Assessment (FMA)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of Community Integration Questionnaire (CIQ)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Genotyping of the BDNF val66met polymorphism(Between baseline and posttest (an expected average of 3 months))
- Change scores of Timed up and go test (TUG)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of Six-minute walk test (6MWT)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of Stroke Impact Scale (SIS)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of muscle strength(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of Geriatric Depression Scale (GDS)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))