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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise
TableSoccer
Sponsored by
University Medical Center Goettingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, negative symptoms, cognitive deficits, synaptic plasticity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dept. of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

SZ-Exercise

SZ-TableSoccer

HC-Exercise

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Hippocampal volume
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
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
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)

Full Information

First Posted
January 1, 2012
Last Updated
May 26, 2015
Sponsor
University Medical Center Goettingen
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1. Study Identification

Unique Protocol Identification Number
NCT01776112
Brief Title
Enhancing Synaptic Plasticity and Cognition in Schizophrenia
Acronym
EXERCISE-II
Official Title
Enhancing Synaptic Plasticity and Cognition by Physical Exercise and Cognitive Training in Schizophrenia: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Goettingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, negative symptoms, cognitive deficits, synaptic plasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SZ-Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
SZ-TableSoccer
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
HC-Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
TableSoccer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hippocampal volume
Description
Measurement of hippocampal volume before and after the exercise intervention, 3T-MRI MPRAGE-Sequence, manual and automated delineation of hippocampal borders
Time Frame
after three months of exercise
Secondary Outcome Measure Information:
Title
Verbal Learning Memory
Description
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)
Time Frame
after three months of exercise
Title
Positive and negative symptoms
Description
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)
Time Frame
after three months of exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Falkai, MD, PhD
Organizational Affiliation
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
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Schmitt, MD, PhD
Organizational Affiliation
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
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Berend Malchow, MD
Organizational Affiliation
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
Official's Role
Study Director
Facility Information:
Facility Name
Dept. of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University
City
Goettingen
State/Province
Lower Saxony
ZIP/Postal Code
37075
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20124113
Citation
Pajonk FG, Wobrock T, Gruber O, Scherk H, Berner D, Kaizl I, Kierer A, Muller 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.
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Enhancing Synaptic Plasticity and Cognition in Schizophrenia

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