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Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Cognitive Training
Physical Training
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia focused on measuring Electroencephalography, Cognitive training, Physical training, Resting state networks

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laboratory of Medical Physics, AUTH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive and Physical Training

Arm Description

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

Outcomes

Primary Outcome Measures

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

Physical fitness
Estimated through 6-Minute Walking Distance (6MWD)
Physical fitness
Estimated through ΒΜΙ
Physical fitness
Estimated through HandGrip Strength Test
Physical fitness
Estimated through Short Physical Performance Battery Protocol
Memory
Estimated through Wechsler Memory - Cubes (visuospatial) test
Executive function
Estimated through FAB (Frontalassesment test)
Depressive syndromes
Estimated through Had's test
Theory of mind
Estimated through Eye's test
Verbal fluency
Estimated through Verbal Fluency test
Visual attention and task switching
Estimated through Trail Making A & B test
Reaction time
Estimated through Stroop test
Generic cogntive impairment
Estimated through Montreal Cognitive Assessment (MoCA) test

Full Information

First Posted
March 29, 2019
Last Updated
February 13, 2020
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT03899662
Brief Title
Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention
Official Title
A Neurophysiological Investigation of the Effectiveness of Web-based Exergaming Platform of Cognitive and Physical Training in Schizophrenic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Electroencephalography, Cognitive training, Physical training, Resting state networks

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive and Physical Training
Arm Type
Experimental
Arm Description
24 sessions (8 weeks, 3 times per week) of computer based 45 minute cognitive and 45 minute physical training.
Intervention Type
Other
Intervention Name(s)
Cognitive Training
Intervention Description
Cognitive training included memory, attention, velocity, intelligence
Intervention Type
Other
Intervention Name(s)
Physical Training
Intervention Description
Physical training included aerobic, strength, flexibility and balance.
Primary Outcome Measure Information:
Title
Alterations in functional connectivity properties and on the organization of resting state networks
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Physical fitness
Description
Estimated through 6-Minute Walking Distance (6MWD)
Time Frame
2 months
Title
Physical fitness
Description
Estimated through ΒΜΙ
Time Frame
2 months
Title
Physical fitness
Description
Estimated through HandGrip Strength Test
Time Frame
2 months
Title
Physical fitness
Description
Estimated through Short Physical Performance Battery Protocol
Time Frame
2 months
Title
Memory
Description
Estimated through Wechsler Memory - Cubes (visuospatial) test
Time Frame
2 months
Title
Executive function
Description
Estimated through FAB (Frontalassesment test)
Time Frame
2 months
Title
Depressive syndromes
Description
Estimated through Had's test
Time Frame
2 months
Title
Theory of mind
Description
Estimated through Eye's test
Time Frame
2 months
Title
Verbal fluency
Description
Estimated through Verbal Fluency test
Time Frame
2 months
Title
Visual attention and task switching
Description
Estimated through Trail Making A & B test
Time Frame
2 months
Title
Reaction time
Description
Estimated through Stroop test
Time Frame
2 months
Title
Generic cogntive impairment
Description
Estimated through Montreal Cognitive Assessment (MoCA) test
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panagiotis Bamidis, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Medical Physics, AUTH
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
15964074
Citation
Hemsley DR. The development of a cognitive model of schizophrenia: placing it in context. Neurosci Biobehav Rev. 2005;29(6):977-88. doi: 10.1016/j.neubiorev.2004.12.008.
Results Reference
background
PubMed Identifier
30180376
Citation
Tagliazucchi E, von Wegner F, Morzelewski A, Borisov S, Jahnke K, Laufs H. Corrigendum to "Automatic sleep staging using fMRI functional connectivity data" [Neuroimage 63/1 (2012) 63-72]. Neuroimage. 2013 Nov 1;81:506. doi: 10.1016/j.neuroimage.2013.05.048. Epub 2013 May 23. No abstract available.
Results Reference
background
PubMed Identifier
25206333
Citation
Frantzidis CA, Vivas AB, Tsolaki A, Klados MA, Tsolaki M, Bamidis PD. Functional disorganization of small-world brain networks in mild Alzheimer's Disease and amnestic Mild Cognitive Impairment: an EEG study using Relative Wavelet Entropy (RWE). Front Aging Neurosci. 2014 Aug 26;6:224. doi: 10.3389/fnagi.2014.00224. eCollection 2014.
Results Reference
background
PubMed Identifier
26731797
Citation
Konstantinidis EI, Billis AS, Mouzakidis CA, Zilidou VI, Antoniou PE, Bamidis PD. Design, Implementation, and Wide Pilot Deployment of FitForAll: An Easy to use Exergaming Platform Improving Physical Fitness and Life Quality of Senior Citizens. IEEE J Biomed Health Inform. 2016 Jan;20(1):189-200. doi: 10.1109/JBHI.2014.2378814.
Results Reference
background
PubMed Identifier
19164577
Citation
Whitfield-Gabrieli S, Thermenos HW, Milanovic S, Tsuang MT, Faraone SV, McCarley RW, Shenton ME, Green AI, Nieto-Castanon A, LaViolette P, Wojcik J, Gabrieli JD, Seidman LJ. Hyperactivity and hyperconnectivity of the default network in schizophrenia and in first-degree relatives of persons with schizophrenia. Proc Natl Acad Sci U S A. 2009 Jan 27;106(4):1279-84. doi: 10.1073/pnas.0809141106. Epub 2009 Jan 21. Erratum In: Proc Natl Acad Sci U S A. 2009 Mar 17;106(11):4572.
Results Reference
background
PubMed Identifier
23966903
Citation
Arbabshirani MR, Kiehl KA, Pearlson GD, Calhoun VD. Classification of schizophrenia patients based on resting-state functional network connectivity. Front Neurosci. 2013 Jul 30;7:133. doi: 10.3389/fnins.2013.00133. eCollection 2013.
Results Reference
result
PubMed Identifier
26300772
Citation
Bamidis PD, Fissler P, Papageorgiou SG, Zilidou V, Konstantinidis EI, Billis AS, Romanopoulou E, Karagianni M, Beratis I, Tsapanou A, Tsilikopoulou G, Grigoriadou E, Ladas A, Kyrillidou A, Tsolaki A, Frantzidis C, Sidiropoulos E, Siountas A, Matsi S, Papatriantafyllou J, Margioti E, Nika A, Schlee W, Elbert T, Tsolaki M, Vivas AB, Kolassa IT. Gains in cognition through combined cognitive and physical training: the role of training dosage and severity of neurocognitive disorder. Front Aging Neurosci. 2015 Aug 7;7:152. doi: 10.3389/fnagi.2015.00152. eCollection 2015.
Results Reference
result
PubMed Identifier
24472698
Citation
Frantzidis CA, Ladas AK, Vivas AB, Tsolaki M, Bamidis PD. Cognitive and physical training for the elderly: evaluating outcome efficacy by means of neurophysiological synchronization. Int J Psychophysiol. 2014 Jul;93(1):1-11. doi: 10.1016/j.ijpsycho.2014.01.007. Epub 2014 Jan 25.
Results Reference
result
PubMed Identifier
21667095
Citation
Rosazza C, Minati L. Resting-state brain networks: literature review and clinical applications. Neurol Sci. 2011 Oct;32(5):773-85. doi: 10.1007/s10072-011-0636-y. Epub 2011 Jun 11.
Results Reference
result

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Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention

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