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临床试验/NCT01776112
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

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

发起方
University Medical Center Goettingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Peter Falkai

Prof. Dr. med. Peter Falkai

University Medical Center Goettingen

研究点 (2)

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