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Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training (BrainTrain)

Primary Purpose

Schizophrenia, Neuronal Plasticity, Exercise

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic Endurance Training
Flexibility, strengthening and balance training
Sponsored by
LMU Klinikum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia

Eligibility Criteria

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

Inclusion Criteria: Written informed consent for voluntary study participation. Patients with schizophrenia: diagnosis of schizophrenic psychosis according to ICD10 and DSM V, Positive And Negative Syndrome Scale (PANSS) total score ≤ 75 before the start of the intervention Reliable contraception in women of childbearing age Patients must have been treated with individualized medication according to valid treatment guidelines. All antipsychotic substances are allowed, also as depot medication. Treatment with one as well as with two antipsychotic substances is possible. The additional administration of low- and medium-potency antipsychotic substances as on-demand medication for the treatment of agitation and sleep disorders is possible, provided that the daily dosage of 150 CPZ units is not exceeded. The active substance and dose of the individualized antipsychotic medication used to achieve the inclusion criterion of psychopathological symptom remission must be constant for at least 2 weeks before inclusion in the study. Exclusion Criteria: Lack of reliability and sanity (examined by an independent psychiatrist) Positive urine drug screen for illicit drugs (except benzodiazepines) Acute suicide risk Other relevant psychiatric axis-I disorders according to the diagnostic testing procedure (Mini International Neuropsychiatric Interview, MINI) Other relevant neurological or other disorders Pregnancy or lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    Aerobic endurance training on a bicycle ergometer

    Flexibility, strengthening and balance training

    Outcomes

    Primary Outcome Measures

    Hippocampal volume
    Change in hippocampal subregion cornu ammonis (CA) 4 volume (∆CA4/DG) and its correlation with polygenetic risk factor (PRS)

    Secondary Outcome Measures

    Cognitive functions
    verbal memory, working memory, motor speed, verbal fluency, attention and speed of information processing assessed by BACS
    Executive functions
    visual attention and task switching (TMT-A, B), episodic memory with the What-Where-When Test and visuo-spatial short- and long-term memory with the Brief Visuospatial Memory Test-Revised (BVMT-R)
    Symptoms severity
    change over study duration assessed by PANSS, BNSS, CDSS
    Functioning in daily life
    Assessed by SOFAS, GAF, FROGS
    Cardiovascular risk factors
    Aerobic fitness levels (W/kg), body weight, waist circumference, body fat, lipid panel, HbA1c, physical activity as assessed with the IPAQ will be evaluated.

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    July 13, 2023
    Sponsor
    LMU Klinikum
    Collaborators
    German Research Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05956327
    Brief Title
    Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
    Acronym
    BrainTrain
    Official Title
    Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2026 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    LMU Klinikum
    Collaborators
    German Research Foundation

    4. Oversight

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

    5. Study Description

    Brief Summary
    Aerobic endurance training has shown positive effects on symptoms, cognition, daily functioning, and the structure of the hippocampus in patients with schizophrenia. The study investigates genetic and epigenetic influences on neuroplastic changes following three months of endurance training. A control group performs flexibility, strength, and balance training. The main objective is to examine the association between a genetic risk score for schizophrenia and volume increase in the CA4/DG region of the hippocampus. Additional goals include examining changes in synapses, brain structure, function, and metabolism, as well as clinical symptoms and cognitive performance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Neuronal Plasticity, Exercise

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    156 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Aerobic endurance training on a bicycle ergometer
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Flexibility, strengthening and balance training
    Intervention Type
    Procedure
    Intervention Name(s)
    Aerobic Endurance Training
    Intervention Description
    Aerobic endurance training on a bicycle ergometer (week 1 to 6: three units per week á 40 minutes, week 7 to 12: three units á 45 minutes, in groups of up to three patients over 13 weeks)
    Intervention Type
    Procedure
    Intervention Name(s)
    Flexibility, strengthening and balance training
    Intervention Description
    Flexibility, strengthening and balance training (exercises from the areas of stretching, strength, balance and relaxation, 3x40 min from week 1-2, 3x45 min from week 3-4 and 3x50 min from week 5-13, in groups of up to three patients over 13 weeks)
    Primary Outcome Measure Information:
    Title
    Hippocampal volume
    Description
    Change in hippocampal subregion cornu ammonis (CA) 4 volume (∆CA4/DG) and its correlation with polygenetic risk factor (PRS)
    Time Frame
    13 weeks
    Secondary Outcome Measure Information:
    Title
    Cognitive functions
    Description
    verbal memory, working memory, motor speed, verbal fluency, attention and speed of information processing assessed by BACS
    Time Frame
    13 weeks
    Title
    Executive functions
    Description
    visual attention and task switching (TMT-A, B), episodic memory with the What-Where-When Test and visuo-spatial short- and long-term memory with the Brief Visuospatial Memory Test-Revised (BVMT-R)
    Time Frame
    13 weeks
    Title
    Symptoms severity
    Description
    change over study duration assessed by PANSS, BNSS, CDSS
    Time Frame
    13 weeks
    Title
    Functioning in daily life
    Description
    Assessed by SOFAS, GAF, FROGS
    Time Frame
    13 weeks
    Title
    Cardiovascular risk factors
    Description
    Aerobic fitness levels (W/kg), body weight, waist circumference, body fat, lipid panel, HbA1c, physical activity as assessed with the IPAQ will be evaluated.
    Time Frame
    13 weeks

    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: Written informed consent for voluntary study participation. Patients with schizophrenia: diagnosis of schizophrenic psychosis according to ICD10 and DSM V, Positive And Negative Syndrome Scale (PANSS) total score ≤ 75 before the start of the intervention Reliable contraception in women of childbearing age Patients must have been treated with individualized medication according to valid treatment guidelines. All antipsychotic substances are allowed, also as depot medication. Treatment with one as well as with two antipsychotic substances is possible. The additional administration of low- and medium-potency antipsychotic substances as on-demand medication for the treatment of agitation and sleep disorders is possible, provided that the daily dosage of 150 CPZ units is not exceeded. The active substance and dose of the individualized antipsychotic medication used to achieve the inclusion criterion of psychopathological symptom remission must be constant for at least 2 weeks before inclusion in the study. Exclusion Criteria: Lack of reliability and sanity (examined by an independent psychiatrist) Positive urine drug screen for illicit drugs (except benzodiazepines) Acute suicide risk Other relevant psychiatric axis-I disorders according to the diagnostic testing procedure (Mini International Neuropsychiatric Interview, MINI) Other relevant neurological or other disorders Pregnancy or lactation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Isabel Maurus, Dr.
    Phone
    +49 89 4400 55537
    Email
    Isabel.Maurus@med.uni-muenchen.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lukas Roell
    Phone
    +49 89 4400 55812
    Email
    Lukas.Roell@med.uni-muenchen.de

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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    Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training

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