NCT05956327

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
4mo left

Started Sep 2023

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Sep 2023Sep 2026

First Submitted

Initial submission to the registry

July 6, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 29, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2.9 years

First QC Date

July 6, 2023

Last Update Submit

November 17, 2023

Conditions

SchizophreniaNeuronal PlasticityExercise

Outcome Measures

Primary Outcomes (1)

  • Hippocampal volume

    Change in hippocampal subregion cornu ammonis (CA) 4 volume (∆CA4/DG) and its correlation with polygenetic risk factor (PRS)

    13 weeks

Secondary Outcomes (5)

  • Cognitive functions

    13 weeks

  • Executive functions

    13 weeks

  • Symptoms severity

    13 weeks

  • Functioning in daily life

    13 weeks

  • Cardiovascular risk factors

    13 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Aerobic endurance training on a bicycle ergometer

Procedure: Aerobic Endurance Training

Control Group

ACTIVE COMPARATOR

Flexibility, strengthening and balance training

Procedure: Flexibility, strengthening and balance training

Interventions

Aerobic Endurance TrainingPROCEDURE

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)

Intervention Group
Flexibility, strengthening and balance trainingPROCEDURE

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)

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LMU Klinikum

Munich, Bavaria, 80336, Germany

RECRUITING

MeSH Terms

Conditions

SchizophreniaMotor Activity

Interventions

Pliability

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • Peter Falkai, Prof. Dr.

    Director of the Department of Psychiatry and Psychotherapy, University Hospital, LMU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Maurus, Dr.

CONTACT

+49 89 4400 55537Isabel.Maurus@med.uni-muenchen.de

Lukas Roell, M.Sc.

CONTACT

+49 89 4400 55812Lukas.Roell@med.uni-muenchen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 21, 2023

Study Start

September 29, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Locations

DE(1)