Walking Our Way to a Healthier Brain: a Randomized Controlled Trial to Evaluate the Effects of Aerobic Exercise, Cognitive Remediation and Combined Intervention in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cognitive performance
研究概览
简要总结
Tracking down the efficacy of a combined intervention of cognitive remediation (CR) and phisycal activity (aerobic exercise, AE) in patients diagnosed with schizophrenia
详细描述
The investigators will address the following objectives:
- Primary objective: o assess, through a randomized controlled trial (RCT), the efficacy and feasibility of a combined intervention (CR + AE) in patients with schizophrenia. The primary outcome measure will be cognitive performance, while secondary outcomes will include scales for the assessment of psychopathology, daily functioning, and quality of life.
- Secondary objectives: to evaluate changes in bio-physical and laboratory metabolic parameters, as well as in neurotrophic and neuroinflammatory factors. Furthermore, multimodal magnetic resonance imaging (MRI) parameters will be evaluated after the interventions, and their relationship with observed cognitive improvements will be explored.
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 (Investigator)
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
- •Patients diagnosed with Schizophrenia
- •Age 18-65 years
- •Psychopathological stability
- •Ability to provide informed consent
排除标准
- •Comorbidity with intellectual disability and neurological disorders.
- •Ongoing treatment with CR or AE.
- •Specific contraindications for AE.
研究组 & 干预措施
Cognitive Remediation (CR)
CR consists of three 1-hour sessions per week of domain-specific computerized exercises, over a 12-week period, for a total of 36 hours
干预措施: Cognitive Remediation (CR) (Behavioral)
Cognitive Remediation (CR)
CR consists of three 1-hour sessions per week of domain-specific computerized exercises, over a 12-week period, for a total of 36 hours
干预措施: Cognitve Remediation + Aerobic Exercise (Other)
Aerobic Exercise (AE)
AE consists of 45 minutes of cycling twice a week, with 15 minutes of warm up pre and post session
干预措施: Aerobic Exercise (Behavioral)
Aerobic Exercise (AE)
AE consists of 45 minutes of cycling twice a week, with 15 minutes of warm up pre and post session
干预措施: Cognitve Remediation + Aerobic Exercise (Other)
Cognitive Remediation and Aerobic Exercise
this intervention is composed by both cognitive remediation and aerobic exercise
干预措施: Cognitive Remediation (CR) (Behavioral)
Cognitive Remediation and Aerobic Exercise
this intervention is composed by both cognitive remediation and aerobic exercise
干预措施: Aerobic Exercise (Behavioral)
Cognitive Remediation and Aerobic Exercise
this intervention is composed by both cognitive remediation and aerobic exercise
干预措施: Cognitve Remediation + Aerobic Exercise (Other)
结局指标
主要结局
Cognitive performance
时间窗: 7 months
Cognition is assessed through the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB): a neuropsychological battery developed for the assessment of the main cognitive domains impaired in schizophrenia. Range T-values: 20-80. Higher values mean a better score
次要结局
- Psychopathology assessment(7 months)
- Quality of Life assessment(7 months)
- Daily functioning assessment(7 months)
- Body Mass Index (BMI)(7 months)
- Diffusion Tensor Imaging (DTI)(4 months)
- Waist circumference(7 months)
- Blood pressure(7 months)
- Metabolic indices(7 months)