SchizophreniaBrainTrainNCT05956327
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
A study testing Aerobic Endurance Training and Flexibility, strengthening and balance training in people with Schizophrenia and Neuronal Plasticity, run by LMU Klinikum at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Neuronal Plasticity, Exercise
- What is being tested?
- Aerobic Endurance Training and Flexibility, strengthening and balance training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteGermany
- Study dates
- 29 Sep 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
LMU Klinikum
Munich, Bavaria, 80336
Lena Deller, M.Sc., 04989440055551, l.deller@med.uni-muenchen.de
About this study
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.
- Conditions
- Schizophrenia, Neuronal Plasticity, Exercise
- Being tested
- Aerobic Endurance Training, Flexibility, strengthening and balance training
- Medical subject headings
- Schizophrenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Endurance TrainingProcedure or 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 trainingProcedure or 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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Aerobic endurance training on a bicycle ergometer Receives: Procedure: Aerobic Endurance Training |
| Control Group | Active comparator | Flexibility, strengthening and balance training Receives: Procedure: Flexibility, strengthening and balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hippocampal volume
Change in hippocampal subregion cornu ammonis (CA) 4 volume (∆CA4/DG) and its correlation with polygenetic risk factor (PRS)
Measured: 13 weeks
Secondary outcomes (5)
Cognitive functions
verbal memory, working memory, motor speed, verbal fluency, attention and speed of information processing assessed by BACS
Measured: 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)
Measured: 13 weeks
Symptoms severity
change over study duration assessed by PANSS, BNSS, CDSS
Measured: 13 weeks
Functioning in daily life
Assessed by SOFAS, GAF, FROGS
Measured: 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.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start29 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Lena Deller, LMU Klinikum
- Investigators
- Peter Falkai, Prof. Dr., Principal investigator, Director of the Department of Psychiatry and Psychotherapy, University Hospital, LMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956327
- Sponsor's protocol ID
- BI 576/9-1, FA 241/21-1
- Acronym
- BrainTrain
- Status last verified
- Nov 2023
- First submitted
- 6 Jul 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
- ClinicalTrials.gov ID
- NCT05956327
- Acronym / sponsor ID
- BrainTrain / BI 576/9-1, FA 241/21-1
- Conditions
- Schizophrenia, Neuronal Plasticity, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Aerobic Endurance TrainingAerobic endurance training on a bicycle ergometer |
| Control Group | Active comparator | Procedure: Flexibility, strengthening and balance trainingFlexibility, strengthening and balance training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Endurance TrainingAerobic 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) | Procedure or surgery | Intervention Group |
| Flexibility, strengthening and balance trainingFlexibility, 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) | Procedure or surgery | Control Group |
Primary outcome
Hippocampal volume
Time frame: 13 weeks
Change in hippocampal subregion cornu ammonis (CA) 4 volume (∆CA4/DG) and its correlation with polygenetic risk factor (PRS)
5 secondary outcomes
Cognitive functions
Time frame: 13 weeks
Executive functions
Time frame: 13 weeks
Symptoms severity
Time frame: 13 weeks
Functioning in daily life
Time frame: 13 weeks
Cardiovascular risk factors
Time frame: 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Falkai, Prof. Dr. principal investigator
Director of the Department of Psychiatry and Psychotherapy, University Hospital, LMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Endurance Training and Flexibility, strengthening and balance training in people with Schizophrenia and Neuronal Plasticity, run by LMU Klinikum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel Maurus, Dr. (+49 89 4400 55537, Isabel.Maurus@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hippocampal volume (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.