Menu
Recruiting NCT05956327

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

No phase Interventional Schizophrenia Neuronal Plasticity Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic Endurance Training, Flexibility, strengthening and balance training.
Who it may be relevant to
Registry conditions: Schizophrenia, Neuronal Plasticity, Exercise. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Aerobic Endurance Training
    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)
  • Procedure Flexibility, strengthening and balance training
    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 measures

  • Hippocampal volume [Time frame: 13 weeks]
Secondary outcome measures (5)
  • Cognitive functions [Time frame: 13 weeks]
  • Executive functions [Time frame: 13 weeks]
  • Symptoms severity [Time frame: 13 weeks]
  • Functioning in daily life [Time frame: 13 weeks]
  • Cardiovascular risk factors [Time frame: 13 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Germany · 1 center
  • LMU Klinikum — Munich

Identifiers

NCT: NCT05956327 · BI 576/9-1, FA 241/21-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗