NCT01776112已完成不适用
Enhancing Synaptic Plasticity and Cognition by Physical Exercise and Cognitive Training in Schizophrenia: A Randomised Controlled Trial
University Medical Center Goettingen2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Hippocampal volume
研究概览
简要总结
To explore: (a) if physical exercise (sports) combined with cognitive training leads to (superior) improvement of cognition in schizophrenia compared to sports or cognitive training alone (b) if a sports program alone or in combination with cognitive training has influence on hippocampal pathology and synaptic plasticity in schizophrenia compared to a placebo condition.
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
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients with the diagnosis of schizophrenia (based on ICD-10 criteria)
- •Age between 18 and 55
- •Verbal IQ ≥ 85
- •Stable psychopathology on constant medication for 2 weeks
- •Informed consent.
排除标准
- •Patients, who are
- •not willing or able to participate in the sports program and cognitive training
- •reveal a significant worsening of psychopathology (based on an increase over 20% of the PANSS positive score)
- •have an organic mental disorder (such as intoxication or neurological disorders of the CNS)
- •suffer from instable somatic diseases
- •have an active substance abuse
结局指标
主要结局
Hippocampal volume
时间窗: after three months of exercise
Measurement of hippocampal volume before and after the exercise intervention, 3T-MRI MPRAGE-Sequence, manual and automated delineation of hippocampal borders
次要结局
- Verbal Learning Memory(after three months of exercise)
- Positive and negative symptoms(after three months of exercise)
研究者
Prof. Dr. Peter Falkai
Prof. Dr. med. Peter Falkai
University Medical Center Goettingen
研究点 (2)
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