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SchizophreniaNCT03899662

Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention

A study testing Cognitive Training and Physical Training in people with Schizophrenia, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Neurophysilogical, neuropsychological evaluation and cognitive and physical training Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Cognitive Training and Physical Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteGreece
Study dates
30 Nov 2018to 31 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Laboratory of Medical Physics, AUTH

    Thessaloniki

Other trials in Greece

About this study

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

Neurophysilogical, neuropsychological evaluation and cognitive and physical training

Read the 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.

Conditions
Schizophrenia
Being tested
Cognitive Training, Physical Training
Keywords
Electroencephalography, Cognitive training, Physical training, Resting state networks
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive TrainingOther

    Cognitive training included memory, attention, velocity, intelligence

  • Physical TrainingOther

    Physical training included aerobic, strength, flexibility and balance.

Study groups in NCT03899662
Study groupRoleWhat they receive
Cognitive and Physical TrainingExperimental24 sessions (8 weeks, 3 times per week) of computer based 45 minute cognitive and 45 minute physical training.
Receives: Other: Cognitive Training; Other: Physical Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (12)

  1. Physical fitness

    Estimated through 6-Minute Walking Distance (6MWD)

    Measured: 2 months

  2. Physical fitness

    Estimated through ΒΜΙ

    Measured: 2 months

  3. Physical fitness

    Estimated through HandGrip Strength Test

    Measured: 2 months

  4. Physical fitness

    Estimated through Short Physical Performance Battery Protocol

    Measured: 2 months

  5. Memory

    Estimated through Wechsler Memory - Cubes (visuospatial) test

    Measured: 2 months

  6. Executive function

    Estimated through FAB (Frontalassesment test)

    Measured: 2 months

  7. Depressive syndromes

    Estimated through Had's test

    Measured: 2 months

  8. Theory of mind

    Estimated through Eye's test

    Measured: 2 months

  9. Verbal fluency

    Estimated through Verbal Fluency test

    Measured: 2 months

  10. Visual attention and task switching

    Estimated through Trail Making A \& B test

    Measured: 2 months

  11. Reaction time

    Estimated through Stroop test

    Measured: 2 months

  12. Generic cogntive impairment

    Estimated through Montreal Cognitive Assessment (MoCA) test

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2019
  2. Study start30 Nov 2018
  3. Primary completion31 Jul 2019
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03899662
Sponsor's protocol ID
SCH15973
Status last verified
Feb 2020
First submitted
29 Mar 2019
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 15964074

  • 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.

    PubMed 30180376

  • 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.

    PubMed 25206333

  • 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.

    PubMed 26731797

  • 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.

    PubMed 19164577

  • 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.

    PubMed 23966903

  • 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.

    PubMed 26300772

  • 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.

    PubMed 24472698

  • 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.

    PubMed 21667095

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Training and Physical Training in people with Schizophrenia, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alterations in functional connectivity properties and on the organization of resting state networks (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03899662, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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