Enhancing Synaptic Plasticity and Cognition in Schizophrenia

Schizophrenia Clinical Trial

— EXERCISE-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776112
• Other study ID #: UMCG-EX-II
• Status: Completed
• Phase: N/A
• First received: January 1, 2012
• Last updated: May 26, 2015
• Start date: January 2011
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: University Medical Center Goettingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Exercise
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.
• TableSoccer
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.

Locations

Country	Name	City	State
Germany	Dept. of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University	Goettingen	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

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