NCT07745140尚未招募不适用
Feasibility of an Integrative Treatment of Brain Stimulation and Exercise on Cognitive Function in Schizophrenia: A Pilot Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Hong Kong List Learning Test (HKLLT)
研究概览
简要总结
The study will investigate the (1) additive and synergistic effects of tDCS and aerobic exercise on cognitive function and clinical symptoms in schizophrenia, and (2) neurophysiological mechanisms (mediators) underlying these effects.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia spectrum disorders;
- •Aged from 18 to
- •Chinese-speaking (to enable cognitive testing).
- •Ability to understand the nature of the study and to give informed consent.
- •Fewer than 10 hours of physical exercise in the previous 3 months.
排除标准
- •Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise with mild-to-moderate intensity may be contraindicated).
- •Comorbid diagnoses of organic brain syndrome, substance misuse, history of epilepsy or seizure, intellectual disability, significant head trauma, active suicidal ideation or self-harm behaviors.
- •Known pregnancy, or other contraindication to tDCS or MRI (e.g., have a cardiac/heart pacemaker, brain aneurysm clips, any implanted metallic or electrical device, or any internal metal foreign objects).
结局指标
主要结局
Hong Kong List Learning Test (HKLLT)
时间窗: Baseline and after the 6-week interventions
A Chinese verbal memory test designed to assess the processes and organizational strategies involved in learning verbal information. The test consists of two different 16-item two-character Chinese word lists, namely the random and blocked conditions. Total learning score, short-term, and long-term memory will be recorded in both conditions.
次要结局
- Rapid Visual Information Processing (RVP)(Baseline and after the 6-week interventions)
- Digit Span (DGS)(Baseline and after the 6-week interventions)
- The Verbal Fluency Test (VFT)(Baseline and after the 6-week interventions)
- 6-Minute Walking Test(Baseline and after the 6-week interventions)
- The Fatigue Assessment Scale (FAS)(Baseline and after the 6-week interventions)
- The sit-and-reach test(Baseline and after the 6-week interventions)
- Standing Balance Test(Baseline and after the 6-week interventions)
- Positive and Negative Syndrome Scale (PANSS)(Baseline and after the 6-week interventions)
- Calgary Depression Scale (CDS)(Baseline and after the 6-week interventions)
- Magnetic Resonance Imaging (MRI)(Baseline and after the 6-week interventions)
研究者
LIN Jingxia Jessie
Assistant Professor
The Hong Kong Polytechnic University
研究点 (1)
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