Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
NCT ID: NCT05956327
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
156 participants
INTERVENTIONAL
2023-09-29
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Intervention Group
Aerobic endurance training on a bicycle ergometer
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)
Control Group
Flexibility, strengthening and balance training
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)
Interventions
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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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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German Research Foundation
OTHER
LMU Klinikum
OTHER
Responsible Party
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Lena Deller
Doctoral Candidate
Principal Investigators
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Peter Falkai, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Director of the Department of Psychiatry and Psychotherapy, University Hospital, LMU
Locations
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LMU Klinikum
Munich, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BI 576/9-1, FA 241/21-1
Identifier Type: -
Identifier Source: org_study_id