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Enhancing Synaptic Plasticity and Cognition in Schizophrenia

Enhancing Synaptic Plasticity and Cognition by Physical Exercise and Cognitive Training in Schizophrenia: A Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01776112
Acronym
EXERCISE-II
Enrollment
66
Registered
2013-01-25
Start date
2011-01-31
Completion date
2014-08-31
Last updated
2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenia, negative symptoms, cognitive deficits, synaptic plasticity

Brief summary

To explore: (a) if physical exercise (sports) combined with cognitive training leads to (superior) improvement of cognition in schizophrenia compared to sports or cognitive training alone (b) if a sports program alone or in combination with cognitive training has influence on hippocampal pathology and synaptic plasticity in schizophrenia compared to a placebo condition.

Interventions

OTHERExercise

Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.

OTHERTableSoccer

Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.

Sponsors

University Medical Center Goettingen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Male and female patients with the diagnosis of schizophrenia (based on ICD-10 criteria) * Age between 18 and 55 * Verbal IQ ≥ 85 * Stable psychopathology on constant medication for 2 weeks * Informed consent.

Exclusion criteria

Patients, who are * not willing or able to participate in the sports program and cognitive training * reveal a significant worsening of psychopathology (based on an increase over 20% of the PANSS positive score) * have an organic mental disorder (such as intoxication or neurological disorders of the CNS) * suffer from instable somatic diseases * have an active substance abuse

Design outcomes

Primary

MeasureTime frameDescription
Hippocampal volumeafter three months of exerciseMeasurement of hippocampal volume before and after the exercise intervention, 3T-MRI MPRAGE-Sequence, manual and automated delineation of hippocampal borders

Secondary

MeasureTime frameDescription
Verbal Learning Memoryafter three months of exerciseNeuropsychological assessment of a working memory domain via the Verbal Learning Memory Test (German: Helmstaedter, C., Lendt, M., Lux, S., 2001. Verbaler Lern- und Merkfähigkeitstest (VLMT). Göttingen, Beltz)
Positive and negative symptomsafter three months of exerciseMeasurement of positive and negative symptoms of schizophrenia using the Positive and Negative Symptom Scale for Schizophrenia (Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026