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NCT Number: NCT05956327

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

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.

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Key information

Conditions

Schizophrenia Behavior Exercise Mental Disorders Motor Activity Neuronal Plasticity Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Endurance Training

Procedure

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)

Flexibility, strengthening and balance training

Procedure

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 outcomes

  1. Hippocampal volume

    Time frame: 13 weeks

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

Secondary outcomes

  1. Cognitive functions

    Time frame: 13 weeks

    verbal memory, working memory, motor speed, verbal fluency, attention and speed of information processing assessed by BACS

  2. Executive functions

    Time frame: 13 weeks

    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)

  3. Symptoms severity

    Time frame: 13 weeks

    change over study duration assessed by PANSS, BNSS, CDSS

  4. Functioning in daily life

    Time frame: 13 weeks

    Assessed by SOFAS, GAF, FROGS

  5. Cardiovascular risk factors

    Time frame: 13 weeks

    Aerobic fitness levels (W/kg), body weight, waist circumference, body fat, lipid panel, HbA1c, physical activity as assessed with the IPAQ will be evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

Isabel Maurus, Dr.

CONTACT

[email protected]

+49 89 4400 55537

Lukas Roell, M.Sc.

CONTACT

[email protected]

+49 89 4400 55812

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Collaborators

  • German Research Foundation

Registry information

Acronym: BrainTrain

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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