Health TrialsbyHealthPanel

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

ConditionsSchizophreniaNeuronal PlasticityExercise
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLMU Klinikum

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic Endurance Training

    Procedure/Surgery

    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/Surgery

    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)

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Cognitive functions

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

Time frame
13 weeks
2

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
3

Symptoms severity

change over study duration assessed by PANSS, BNSS, CDSS

Time frame
13 weeks
4

Functioning in daily life

Assessed by SOFAS, GAF, FROGS

Time frame
13 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LMU Klinikum

Lead sponsor

German Research Foundation

Collaborator

Source ClinicalTrials.gov
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