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

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

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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