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

U

University Medical Center Goettingen

Status

Completed

Conditions

Schizophrenia

Treatments

Other: Exercise
Other: TableSoccer

Study type

Interventional

Funder types

Other

Identifiers

NCT01776112
UMCG-EX-II

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 3 patient groups, including a placebo group

SZ-Exercise
Experimental group
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.
Treatment:
Other: Exercise
SZ-TableSoccer
Placebo Comparator group
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.
Treatment:
Other: TableSoccer
HC-Exercise
Experimental group
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.
Treatment:
Other: Exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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