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Completed

NCT Number: NCT01776112

Enhancing Synaptic Plasticity and Cognition in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Cognition Disorders Mental Disorders Neurocognitive Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Göttingen, Lower Saxony, 37075, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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

Other

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 outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Official study title

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

Acronym: EXERCISE-II

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 25, 2013
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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