Actively Recruiting
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
Led by LMU Klinikum · Updated on 2023-11-21
156
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
LMU Klinikum
Lead Sponsor
G
German Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how aerobic endurance training affects patients with schizophrenia, focusing on changes in the brain's hippocampus, symptoms, cognition, and daily functioning. The study aims to understand genetic and epigenetic factors influencing brain plasticity after three months of endurance training compared to a control group performing flexibility, strengthening, and balance exercises. The main goal is to examine how a genetic risk score for schizophrenia relates to volume changes in a specific hippocampal region called CA4/DG. Participants are randomly assigned to either aerobic endurance training using a bicycle ergometer or to flexibility, strengthening, and balance training. The endurance training starts with three 40-minute sessions per week for six weeks, then three 45-minute sessions per week for the next six weeks, conducted in small groups. The control group performs exercises focusing on stretching, strength, balance, and relaxation, with session durations increasing from 40 to 50 minutes over 13 weeks. During the 13-week study, participants undergo assessments of hippocampal volume, cognitive and executive functions, symptom severity, daily life functioning, and cardiovascular risk factors. The trial includes double-blind monitoring, and all participants receive individualized medication following standard treatment guidelines. The total study period allows researchers to observe brain structure and functional changes related to physical training in schizophrenia.
CONDITIONS
Brief Title
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent for voluntary study participation.
- Diagnosis of schizophrenic psychosis according to ICD10 and DSM V.
- Positive And Negative Syndrome Scale (PANSS) total score of 75 or less before starting the intervention.
- Reliable contraception use in women of childbearing age.
- Treatment with individualized antipsychotic medication according to current guidelines, stable for at least 2 weeks before inclusion.
- Use of one or two antipsychotic substances allowed, including depot medications.
- Low- and medium-potency antipsychotics allowed as needed for agitation or sleep, with dosage limits.
You will not qualify if you...
- Lack of reliability and sanity, as assessed by an independent psychiatrist.
- Positive urine drug screen for illicit drugs except benzodiazepines.
- Acute suicide risk.
- Presence of other significant psychiatric axis-I disorders.
- Presence of relevant neurological or other disorders.
- Pregnancy or lactation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 13 weeks
Participants engage in either aerobic endurance training on a bicycle ergometer or flexibility, strengthening and balance training in groups over 13 weeks.
Three training sessions per week, each lasting 40 to 50 minutes depending on the week
Trial Site Locations
Total: 1 location
1
LMU Klinikum
Munich, Bavaria, Germany, 80336
Actively Recruiting
Research Team
I
Isabel Maurus, Dr.
L
Lukas Roell, M.Sc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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