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OpenTrials
Completed

NCT Number: NCT03899662

Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention

Neurophysilogical, neuropsychological evaluation and cognitive and physical training

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Medical Physics, AUTH

Thessaloniki, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Training

Other

Cognitive training included memory, attention, velocity, intelligence

Physical training

Other

Physical training included aerobic, strength, flexibility and balance.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2019
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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