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

May 26, 2015 updated by: Prof. Dr. Peter Falkai, University Medical Center Goettingen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Goettingen, Lower Saxony, Germany, 37075
        • Dept. of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hippocampal volume
Time Frame: after three months of exercise
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal Learning Memory
Time Frame: after three months of exercise
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
Positive and negative symptoms
Time Frame: after three months of exercise
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 1, 2012

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 25, 2013

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCG-EX-II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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