Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Other: Cognitive Training; Other: Physical Training

• Registration Number: NCT03899662
• Lead Sponsor: Aristotle University Of Thessaloniki

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 Timeline

• Study Start: 2018-11-30
• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive and Physical Training	Cognitive Training	24 sessions (8 weeks, 3 times per week) of computer based 45 minute cognitive and 45 minute physical training.
Cognitive and Physical Training	Physical Training	24 sessions (8 weeks, 3 times per week) of computer based 45 minute cognitive and 45 minute physical training.

Primary Outcome Measures

Name	Time	Method
Alterations in functional connectivity properties and on the organization of resting state networks	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

Name	Time	Method
Reaction time	2 months	Estimated through Stroop test
Theory of mind	2 months	Estimated through Eye's test
Executive function	2 months	Estimated through FAB (Frontalassesment test)
Physical fitness	2 months	Estimated through Short Physical Performance Battery Protocol
Memory	2 months	Estimated through Wechsler Memory - Cubes (visuospatial) test
Visual attention and task switching	2 months	Estimated through Trail Making A \& B test
Generic cogntive impairment	2 months	Estimated through Montreal Cognitive Assessment (MoCA) test
Depressive syndromes	2 months	Estimated through Had's test
Verbal fluency	2 months	Estimated through Verbal Fluency test

Trial Locations

Locations (1)

Laboratory of Medical Physics, AUTH; 🇬🇷 Thessaloniki, Greece