A Randomized, Open-Label, Parallel-Group Study to Investigate The Effect of Cognitive Training and Aerobic Exercise on Brain, Functional Outcome and Cognition in Schizophrenia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Fractional Anisotropy Change
研究概览
简要总结
This study evaluates the brain correlates of Cognitive Training and Aerobic Exercise in schizophrenia. A third of participants will receive Cognitive Training plus Standard Care for schizophrenia. Another third of participants will receive Aerobic Exercise Training plus Standard Care for schizophrenia. A control group will of participants will receive Standard Care plus Occupational Activities for the same duration and frequency as the experimental groups.
详细描述
This study, randomized, open, controlled with schizophrenia-standard-care, is aimed to determine structural and functional brain changes associated to cognitive remediation and physical exercise in schizophrenia.
The study participants will be enrolled in the catchment area of the Hospital Psiquiatrico de Alava, in the province of Alava, Basque Region, Northern Spain.147 patients diagnosed with schizophrenia will be randomly assigned to Cognitive Training Group or Aerobic Exercise Group or a Control Group for a five-month period.
Both Cognitive Training Group patients and Aerobic Exercise Group patients will participate in training sessions of 60 min/d, 3 d/wk. Patients assigned to Control Group will receive the standard care for schizophrenia in this area plus occupational activities for the same duration and frequency than the two experimental groups.
Cognitive Training will be implemented through REHACOP, a cognitive remediation program for Spanish speaking patients with schizophrenia whose efficacy on cognitive performance and negative symptoms has already been demonstrated in patients with schizophrenia. REHACOP is a "paper & pencil" based cognitive remediation program that covers 8 cognitive domains including social cognition. It is based on the principles of Optimization, Restauration & Compensation.
Aerobic Exercise Training will consist of an intensive physical exercise program supervised by certified graduates and doctorate students of Physical Activity and Sport Sciences. Sessions will include 10-minute warming-up and 10-minute back exercises and stretches. The main part of the session will consist of aerobic exercise (20-minute indoor bicycle) and muscle-resistance and strength exercises for 20 minutes. The intensity of the sessions will be determined on a case by case basis according to the HR necessary to achieve the intensity ranges (R2-moderate and R3-high). During the sessions, the bicycle's power and pace will be individually adjusted to achieve the selected HR.
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 (Investigator, Outcomes Assessor)
盲法说明
Patients are trained to not comment about the type of treatment they have been assigned to with the investigator who performs the assessments.
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
- •Diagnosis of Schizophrenia (DSM-5 F20.9)
- •More than 2 years since the onset of the disease.
- •Stable cognitive impairment.
- •Moderate severity of cognitive impairment in MATRICS scores (T score < 40 in, at least, 1 out of 7 cognitive domains).
排除标准
- •Subjects clinically unstable (PANSS positive score > 19).
- •Cognitive impairment due to another medical condition (neurocognitive disorders, brain injury, intellectual disability, etc.)
研究组 & 干预措施
Treatment as usual
The TaU Group receives the usual treatment that patients with schizophrenia in Spain enriched with occupational activities administered 3 times a week with a duration of 60 minutes each session.
干预措施: Treatment as usual (Behavioral)
Aerobic Exercise
This program consists of an exercise dosage of 180 min/week administered in 3 sessions of 60 minutes. Each session includes 10 minutes of warm-up exercise before the main exercise and 10 minutes of cool-down afterwards.the principal exercise section includes 20 minutes of aerobic exercise and 20 minutes of resistance and strength exercises. The exercise intensity will be regulated according to the heart rate measured by a pulsimeter throughout the exercise. The target intensity level will be individualized according to the heart rate to set the moderate intensity level (HR values between ventilatory thresholds) and high intensity level (HR values from 2nd. ventilatory threshold to the peak threshold).
干预措施: Aerobic Exercise (Behavioral)
Cognitive Training
The CT group participates in a cognitive remediation program. This program consists of 3 sessions of 60 minutes per week. CT will be administered in groups of 5-8 subjects. The cognitive domains involved in the CT are attention/concentration, memory/learning, language, executive functions, social cognition, social skills, daily living activities and psychoeducation. Cognitive Remediation will be provided by using REHACOP, a cognitive remediation training tool designed and validated for Spanish patients with schizophrenia.
干预措施: Cognitive Training (Behavioral)
Treatment as usual
The TaU Group receives the usual treatment that patients with schizophrenia in Spain enriched with occupational activities administered 3 times a week with a duration of 60 minutes each session.
干预措施: Occupational Activities (Behavioral)
结局指标
主要结局
Fractional Anisotropy Change
时间窗: 5 months
Assessment of changes in fractional anisotropy of White Matter fibers by Diffusion Tensor MR Imaging and using the Tract-Based Spatial Statistics (TBSS).
Functional Magnetic Resonance Imaging (fMRI) Change at Rest
时间窗: 5 months
Assessment of changes in fMRI at rest with the Coon Functional Connectivity Toolbox.
Functional Magnetic Resonance Imaging (fMRI) Change during the performance of a cognitive paradigm.
时间窗: 5 months
Assessment of changes in fMRI during the performance of a cognitive paradigm with Statistical Parametric Mapping (SPM8).
Grey Matter Volume Change
时间窗: 5 months
Assessment of Grey Matter volume changes (T1-weighted MRI) among the 3 groups using Voxel Based Morphometry (VBM).
次要结局
- Height(5 months)
- Functional Outcome measured by the World Health Organization Disability Assessment Schedule (WHODAS 2.0).(5 months)
- Body composition measured with Body Mass Index (BMI)(5 months.)
- Physical Condition measured by the Modified Shuttle Walking Test(5 months)
- Cardiorespiratory Fitness measured with the Peak Oxygen Uptake (VO2 max)(5 months)
- Serum BDNF(5 months.)
- Clinical Symptoms of Schizophrenia measured by the Positive and Negative Symptoms Scale (PANSS).(5 months.)
- Negative Symptoms of Schizophrenia measured by the Brief Negative Symptoms Scale (BNSS).(5 months)
- Negative Symptoms of Schizophrenia measured by the Clinical Assessment Interview for Negative Symptoms Scale (CAINS)(5 months)
- Functional Outcome measured by the UCSD Performance Based Assessment of Functional Skills in Severe Mental Illness (UPSA).(5 months)
- Weight.(5 months)
- Functional Outcome measured by the Short Form (36) Health Survey (SF-36).(5 months)
- Abdominal Perimeter(5 months)
- Body Composition measured with Total Body Water.(5 months)
- Body Composition measured with Body Fat.(5 months)
- Blood Pressure (systolic and diastolic)(5 months)
- Level of Daytime Sleepiness measured by Epworth Sleepiness Scale (ESS)ESS-EPWORTH.(5 months)
- Cognition-Processing Speed(5 months)
- Cognition-Reasoning/Problem Solving(5 months)
- Fasting Blood Glucose Levels(5 months)
- Fasting Cholesterol Levels(5 months)
- Daily Physical Activity and Sedentary Behavior measured by the International Physical Activity Questionnaire.(5 months)
- Intensity of Daily Physical Activity measured by the Accelerometer.(5 months)
- Cognition-Working Memory Digit Span Backward(5 months)
- Cognition-Verbal Learning/Memory(5 months)
- Cognition-Attention/Vigilance Stroop Test(5 months)
- Cognition-Cognitive Reserve(5 months)
- Cognition-Figural Creativity(5 months)
- Cognition-Verbal Creativity(5 months)
- Social Cognition-Social Attribution(5 months)
- Social Cognition-Emotion Recognition(5 months)
- Social Cognition-Theory of Mind(5 months)
- Social Functioning measured by the Social Functioning Scale Short-Form (SFS-15)(5 months)
- Self-Efficacy measured by the General Self-Efficacy Scale(5 months)
- Social Anhedonia measured with the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)(5 months)
- Handedness measured by the Edinburgh Handedness Inventory(5 months)
- Treatment satisfaction measured by the Spanish version of Consumer Reports Effectiveness Scale (CRES-4)(5 months)