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Clinical Trials/NCT03899662
NCT03899662
Completed
Not Applicable

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

Aristotle University Of Thessaloniki1 site in 1 country4 target enrollmentNovember 30, 2018
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Aristotle University Of Thessaloniki
Enrollment
4
Locations
1
Primary Endpoint
Alterations in functional connectivity properties and on the organization of resting state networks
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Neurophysilogical, neuropsychological evaluation and cognitive and physical training

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 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.

Registry
clinicaltrials.gov
Start Date
November 30, 2018
End Date
July 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Panos Bamidis

Associate Professor

Aristotle University Of Thessaloniki

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Reaction time(2 months)
  • Physical fitness(2 months)
  • Visual attention and task switching(2 months)
  • Generic cogntive impairment(2 months)
  • Memory(2 months)
  • Executive function(2 months)
  • Theory of mind(2 months)
  • Depressive syndromes(2 months)
  • Verbal fluency(2 months)

Study Sites (1)

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