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

LMU Klinikum156 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

156

Conditions

Schizophrenia Neuronal Plasticity Exercise

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hippocampal volume

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

Time frame: 13 weeks

Secondary Outcomes

Cognitive functions

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

Time frame: 13 weeks

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)

Time frame: 13 weeks

Symptoms severity

change over study duration assessed by PANSS, BNSS, CDSS

Time frame: 13 weeks

Functioning in daily life

Assessed by SOFAS, GAF, FROGS

Time frame: 13 weeks

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.

Time frame: 13 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts