Aerobic Exercise for the Improvement of Cognition and Enhancement of Recovery in Post-acute Schizophrenia

Ludwig Maximilian University of Munich

Status

Completed

Conditions

Schizophrenia

Treatments

Other: balance and tone program

Other: endurance training

Study type

Interventional

Funder types

Other

Identifiers

NCT03466112

Version (V) 2.0 - 30.07.2018

Details and patient eligibility

About

The study investigates the efficacy of aerobic exercise on cognitive performance and brain plasticity in schizophrenia.

Full description

This multi-center, two-arm, parallel-group, randomized placebo-controlled add-on clinical trial investigates the efficacy of aerobic exercise on cognitive performance and brain plasticity in schizophrenia. The aim is the enhancement of recovery with the use of 26 weeks of continuos endurance training (aerobic exercise) with stationary bicycles or a balance and tone program consisting of exercises for flexibility, core strength, balance and relaxation. Followed by a follow-up period of 26 weeks.

Enrollment

180 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Informed consent given by the subject; DSM-IV-TR diagnosis of schizophrenic psychosis (295.10-30, 295.90); age 18 to 65 years, male or female; PANSS at baseline: total score ≤ 75, proper contraception in female patients of childbearing potential; treatment with one or two antipsychotics in a stable dose of at least two weeks, body mass index between 18 and 40.

Exclusion criteria

Lack of accountability; positive urine drug-screening for illicit drugs at screening (except benzodiazepines); serious suicidal risk at screening visit; other relevant interferences of axis 1 according to diagnostic evaluation (MINI); other relevant neurological or other medical disorders; pregnancy or lactation.