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Enhancing Synaptic Plasticity and Cognition in Schizophrenia (EXERCISE-II)

This study is currently recruiting participants.
Verified January 2013 by University Medical Center Goettingen
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Peter Falkai, University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT01776112
First received: January 1, 2012
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Schizophrenia
 Other: Exercise
Other: TableSoccer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Synaptic Plasticity and Cognition by Physical Exercise and Cognitive Training in Schizophrenia: A Randomised Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Center Goettingen:

Primary Outcome Measures:
  • Hippocampal volume [ Time Frame: after three months of exercise ] [ Designated as safety issue: No ]
    Measurement of hippocampal volume before and after the exercise intervention, 3T-MRI MPRAGE-Sequence, manual and automated delineation of hippocampal borders


Secondary Outcome Measures:
  • Verbal Learning Memory [ Time Frame: after three months of exercise ] [ Designated as safety issue: No ]
    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)

  • Positive and negative symptoms [ Time Frame: after three months of exercise ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SZ-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.
 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.
Placebo Comparator: SZ-TableSoccer
Standard treatment and participation in an activity without physical improvement as placebo condition (table soccer 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.
 Other: 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.
Experimental: HC-Exercise
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776112

Contacts
Contact: Berend Malchow, MD 0049-551-39-6610 bmalcho@gwdg.de

Locations
Germany
Dept. of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University Recruiting
Goettingen, Lower Saxony, Germany, 37075
Contact: Berend Malchow, MD     0049-551-39- ext 6610     bmalcho@gwdg.de    
Sub-Investigator: Berend Malchow, MD            
Principal Investigator: Peter Falkai, MD, PhD            
Sponsors and Collaborators
University Medical Center Goettingen
Investigators
Principal Investigator: Peter Falkai, MD, PhD Head, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610
Study Director: Andrea Schmitt, MD, PhD Professor, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610
Study Director: Berend Malchow, MD Senior Consultant, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610
  More Information

Publications:

Responsible Party: Prof. Dr. Peter Falkai, Prof. Dr. med. Peter Falkai, University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT01776112     History of Changes
Other Study ID Numbers: UMCG-EX-II
Study First Received: January 1, 2012
Last Updated: January 22, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University Medical Center Goettingen:
schizophrenia
negative symptoms
cognitive deficits
synaptic plasticity

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013