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Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03899662
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Information provided by (Responsible Party):
Panos Bamidis, Aristotle University Of Thessaloniki

Brief Summary:
Neurophysilogical, neuropsychological evaluation and cognitive and physical training

Condition or disease Intervention/treatment Phase
Schizophrenia Other: Cognitive Training Other: Physical Training Not Applicable

Detailed Description:
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 and 45 minutes of physical training (FitForAll platform 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Neurophysiological Investigation of the Effectiveness of Web-based Exergaming Platform of Cognitive and Physical Training in Schizophrenic Patients
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cognitive and Physical Training
24 sessions (8 weeks, 3 times per week) of computer based 45 minute cognitive and 45 minute physical training.
Other: Cognitive Training
Cognitive training included memory, attention, velocity, intelligence

Other: Physical Training
Physical training included aerobic, strength, flexibility and balance.

Primary Outcome Measures :
  1. Alterations in functional connectivity properties and on the organization of resting state networks [ Time Frame: 3 months ]
    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.

Secondary Outcome Measures :
  1. Physical fitness [ Time Frame: 2 months ]
    Estimated through 6-Minute Walking Distance (6MWD)

  2. Physical fitness [ Time Frame: 2 months ]
    Estimated through ΒΜΙ

  3. Physical fitness [ Time Frame: 2 months ]
    Estimated through HandGrip Strength Test

  4. Physical fitness [ Time Frame: 2 months ]
    Estimated through Short Physical Performance Battery Protocol

  5. Memory [ Time Frame: 2 months ]
    Estimated through Wechsler Memory - Cubes (visuospatial) test

  6. Executive function [ Time Frame: 2 months ]
    Estimated through FAB (Frontalassesment test)

  7. Depressive syndromes [ Time Frame: 2 months ]
    Estimated through Had's test

  8. Theory of mind [ Time Frame: 2 months ]
    Estimated through Eye's test

  9. Verbal fluency [ Time Frame: 2 months ]
    Estimated through Verbal Fluency test

  10. Visual attention and task switching [ Time Frame: 2 months ]
    Estimated through Trail Making A & B test

  11. Reaction time [ Time Frame: 2 months ]
    Estimated through Stroop test

  12. Generic cogntive impairment [ Time Frame: 2 months ]
    Estimated through Montreal Cognitive Assessment (MoCA) test

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03899662

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Contact: Christos Frantzidis, PhD 00302310999310
Contact: Christina Plomariti, MSc 00302310999310

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Laboratory of Medical Physics, AUTH Recruiting
Thessaloniki, Greece
Contact: Panagiotis Bamidis, Dr.    00302310999310   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
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Principal Investigator: Panagiotis Bamidis, PhD Associate Professor

Publications of Results:
Other Publications:

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Responsible Party: Panos Bamidis, Associate Professor, Aristotle University Of Thessaloniki Identifier: NCT03899662     History of Changes
Other Study ID Numbers: SCH15973
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Panos Bamidis, Aristotle University Of Thessaloniki:
Cognitive training
Physical training
Resting state networks

Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders