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

LMU Klinikum

Status: Enrolling

Conditions: Schizophrenia; Neuronal Plasticity; Exercise

Treatments: Procedure: Flexibility, strengthening and balance training; Procedure: Aerobic Endurance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05956327

BI 576/9-1, FA 241/21-1

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Aerobic endurance training on a bicycle ergometer

Treatment:

Procedure: Aerobic Endurance Training

Control Group

Active Comparator group

Description:

Flexibility, strengthening and balance training

Treatment:

Procedure: Flexibility, strengthening and balance training