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

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 Overview

• Status: Recruiting
• Conditions: Schizophrenia; Exercise; Neuronal Plasticity
• Intervention / Treatment: Procedure: Aerobic Endurance Training; Procedure: Flexibility, strengthening and balance training

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabel Maurus, Dr.; Phone Number: +49 89 4400 55537; Email: Isabel.Maurus@med.uni-muenchen.de
• Study Contact Backup: Name: Lukas Roell, M.Sc.; Phone Number: +49 89 4400 55812; Email: Lukas.Roell@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80336
      • Recruiting
      • LMU Klinikum
      • Contact: Lena Deller, M.Sc.; Phone Number: 04989440055551; Email: l.deller@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Aerobic endurance training on a bicycle ergometer	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)
Active Comparator: Control Group; Flexibility, strengthening and balance training	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hippocampal volume	Change in hippocampal subregion cornu ammonis (CA) 4 volume (∆CA4/DG) and its correlation with polygenetic risk factor (PRS)	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive functions	verbal memory, working memory, motor speed, verbal fluency, attention and speed of information processing assessed by BACS	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)	13 weeks
Symptoms severity	change over study duration assessed by PANSS, BNSS, CDSS	13 weeks
Functioning in daily life	Assessed by SOFAS, GAF, FROGS	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.	13 weeks

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Collaborators: German Research Foundation
• Investigators: Principal Investigator: Peter Falkai, Prof. Dr., Director of the Department of Psychiatry and Psychotherapy, University Hospital, LMU

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: BI 576/9-1, FA 241/21-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No