Enhancing Synaptic Plasticity and Cognition in Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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Enhancing Synaptic Plasticity and Cognition by Physical Exercise and Cognitive Training in Schizophrenia: A Randomised Controlled Trial

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: Exercise
* Other: TableSoccer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SZ-Exercise<br>Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks. | Other: Exercise<br>* Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.<br>|
| Placebo Comparator: SZ-TableSoccer<br>Standard treatment and participation in an activity without physical improvement as placebo condition (table soccer in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks. | Other: TableSoccer<br>* Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.<br>|
| Experimental: HC-Exercise<br>Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks. | Other: Exercise<br>* Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hippocampal volume | Measurement of hippocampal volume before and after the exercise intervention, 3T-MRI MPRAGE-Sequence, manual and automated delineation of hippocampal borders | after three months of exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Learning Memory | Neuropsychological assessment of a working memory domain via the Verbal Learning Memory Test (German: Helmstaedter, C., Lendt, M., Lux, S., 2001. Verbaler Lern- und Merkfähigkeitstest (VLMT). Göttingen, Beltz) | after three months of exercise | 
| Positive and negative symptoms | Measurement of positive and negative symptoms of schizophrenia using the Positive and Negative Symptom Scale for Schizophrenia (Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76) | after three months of exercise | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, negative symptoms, cognitive deficits, synaptic plasticity