Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention

Study Overview
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Brief Summary
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Neurophysilogical, neuropsychological evaluation and cognitive and physical training

Detailed Description
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24 sessions (8 weeks, 3 times per week) of cognitive and physical training via computer. Each session consisted of 45 minutes of cognitive traing (BrainHQ platform https://www.brainhq.com/) and 45 minutes of physical training (FitForAll platform https://www.fitforall.gr/play/app/). Cognitive training included memory, attention, velocity, intelligence etc. Physical training included aerobic, strength flexibility and other excercises. All evaluations were performed 1-14 before the initiation of the interventions and 1-14 after their completion. Neurophysiological evaluation consisted of EEG with the use of 128 electrode-machine and the protocol included 5 minuted of eyes closed and 5 minutes of eyes open. Neuropsychological evaluation included Trail Making Test (A & B), Verbal Fluency, Stroop test, Wechsler Memory - Cubes (visuospatial), MoCA, FAB (Screening for frontal damage) and Eyes Test (Theory of Mind). Also, the physical condition evaluation included 6-Minute Walking Distance (6MWD), ΒΜΙ, HandGrip Strength Test, Short Physical Performance Battery Protocol.

Official Title
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A Neurophysiological Investigation of the Effectiveness of Web-based Exergaming Platform of Cognitive and Physical Training in Schizophrenic Patients

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: Cognitive Training
* Other: Physical Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of schizophrenia disorder according to ICD10 criteria clinically stable patients (no recent change in psychotropic medication except benzodiazepines) sufficient acculturation and fluency in Greek language assent of the attending physician for participation in the study Exclusion Criteria: co-morbidity with neurological disorders (e.g.epilepsy) or head injury a pathological or other somatic disorder that contraindicate physical exercise alcoholism and substance abuse within the previous 3 months (except caffeine and tobacco) abstainance from intervention for more than 12 days cognitive decline treated with Benzodiazepine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive and Physical Training<br>24 sessions (8 weeks, 3 times per week) of computer based 45 minute cognitive and 45 minute physical training. | Other: Cognitive Training<br>* Cognitive training included memory, attention, velocity, intelligence<br>Other: Physical Training<br>* Physical training included aerobic, strength, flexibility and balance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alterations in functional connectivity properties and on the organization of resting state networks | Alterations in functional connectivity properties and on the organization of resting state networks quantified through graph theory tools. These measures would be measured through high-density electroencephalographic (EEG) evaluation and reconstruction of cortical activity. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical fitness | Estimated through 6-Minute Walking Distance (6MWD) | 2 months | 
| Physical fitness | Estimated through ΒΜΙ | 2 months | 
| Physical fitness | Estimated through HandGrip Strength Test | 2 months | 
| Physical fitness | Estimated through Short Physical Performance Battery Protocol | 2 months | 
| Memory | Estimated through Wechsler Memory - Cubes (visuospatial) test | 2 months | 
| Executive function | Estimated through FAB (Frontalassesment test) | 2 months | 
| Depressive syndromes | Estimated through Had's test | 2 months | 
| Theory of mind | Estimated through Eye's test | 2 months | 
| Verbal fluency | Estimated through Verbal Fluency test | 2 months | 
| Visual attention and task switching | Estimated through Trail Making A & B test | 2 months | 
| Reaction time | Estimated through Stroop test | 2 months | 
| Generic cogntive impairment | Estimated through Montreal Cognitive Assessment (MoCA) test | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroencephalography, Cognitive training, Physical training, Resting state networks