Schizophrenia Clinical Trial
— EXERCISE-IIOfficial title:
Enhancing Synaptic Plasticity and Cognition by Physical Exercise and Cognitive Training in Schizophrenia: A Randomised Controlled Trial
Verified date | May 2015 |
Source | University Medical Center Goettingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | August 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Dept. of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University | Goettingen | Lower Saxony |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Goettingen |
Germany,
Pajonk FG, Wobrock T, Gruber O, Scherk H, Berner D, Kaizl I, Kierer A, Müller S, Oest M, Meyer T, Backens M, Schneider-Axmann T, Thornton AE, Honer WG, Falkai P. Hippocampal plasticity in response to exercise in schizophrenia. Arch Gen Psychiatry. 2010 Feb;67(2):133-43. doi: 10.1001/archgenpsychiatry.2009.193. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hippocampal volume | Measurement of hippocampal volume before and after the exercise intervention, 3T-MRI MPRAGE-Sequence, manual and automated delineation of hippocampal borders | after three months of exercise | No |
Secondary | Verbal Learning Memory | Neuropsychological 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) | after three months of exercise | No |
Secondary | Positive and negative symptoms | Measurement 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) | after three months of exercise | No |
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