NCT03899662

Brief Summary

Neurophysilogical, neuropsychological evaluation and cognitive and physical training

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

March 29, 2019

Last Update Submit

February 13, 2020

Conditions

Schizophrenia

Keywords

ElectroencephalographyCognitive trainingPhysical trainingResting state networks

Outcome Measures

Primary Outcomes (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.

    3 months

Secondary Outcomes (12)

  • Physical fitness

    2 months

  • Physical fitness

    2 months

  • Physical fitness

    2 months

  • Physical fitness

    2 months

  • Memory

    2 months

  • +7 more secondary outcomes

Study Arms (1)

Cognitive and Physical Training

EXPERIMENTAL

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

Other: Cognitive TrainingOther: Physical Training

Interventions

Cognitive TrainingOTHER

Cognitive training included memory, attention, velocity, intelligence

Cognitive and Physical Training
Physical TrainingOTHER

Physical training included aerobic, strength, flexibility and balance.

Cognitive and Physical Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Medical Physics, AUTH

Thessaloniki, Greece

Location

Related Publications (9)

  • 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.

    PMID: 15964074BACKGROUND

  • 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.

    PMID: 30180376BACKGROUND

  • 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.

    PMID: 25206333BACKGROUND

  • 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.

    PMID: 26731797BACKGROUND

  • 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.

    PMID: 19164577BACKGROUND

  • 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.

    PMID: 23966903RESULT

  • 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.

    PMID: 26300772RESULT

  • 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.

    PMID: 24472698RESULT

  • 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.

    PMID: 21667095RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive TrainingPhysical Conditioning, Human

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Panagiotis Bamidis, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 2, 2019

Study Start

November 30, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

GR(1)