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Clinical Trials/NCT03899662
NCT03899662CompletedNot 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 enrollmentStarted: November 30, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
4
Locations
1
Primary Endpoint
Alterations in functional connectivity properties and on the organization of resting state networks

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Cognitive and Physical Training

Experimental

24 sessions (8 weeks, 3 times per week) of computer based 45 minute cognitive and 45 minute physical training.

Intervention: Cognitive Training (Other)

Cognitive and Physical Training

Experimental

24 sessions (8 weeks, 3 times per week) of computer based 45 minute cognitive and 45 minute physical training.

Intervention: Physical Training (Other)

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

  • Physical fitness(2 months)
  • Reaction time(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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Panos Bamidis

Associate Professor

Aristotle University Of Thessaloniki

Study Sites (1)

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