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

Обзор

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.

Вмешательства

• Процедура 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)
• Процедура 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)

Первичные конечные точки

• Hippocampal volume [Срок оценки: 13 weeks]

Вторичные конечные точки (5)

• Cognitive functions [Срок оценки: 13 weeks]
• Executive functions [Срок оценки: 13 weeks]
• Symptoms severity [Срок оценки: 13 weeks]
• Functioning in daily life [Срок оценки: 13 weeks]
• Cardiovascular risk factors [Срок оценки: 13 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Германия · 1 центр

• LMU Klinikum — Munich

Идентификаторы

NCT: NCT05956327 · BI 576/9-1, FA 241/21-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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