Aerobic endurance training to improve cognition and enhance recovery in schizophrenia: design and methodology of a multicenter randomized controlled trial

Abstract

Even today, patients with schizophrenia often have an unfavorable outcome. Negative symptoms and cognitive deficits are common features in many patients and prevent recovery. In recent years, aerobic endurance training has emerged as a therapeutic approach with positive effects on several domains of patients’ health. However, appropriately sized, multicenter randomized controlled trials that would allow better generalization of results are lacking. The exercise study presented here is a multicenter, rater-blind, two-armed, parallel-group randomized clinical trial in patients with clinically stable schizophrenia being conducted at five German tertiary hospitals. The intervention group performs aerobic endurance training on bicycle ergometers three times per week for 40–50 min/session (depending on the intervention week) for a total of 26 weeks, and the control group performs balance and tone training for the same amount of time. Participants are subsequently followed up for 26 weeks. The primary endpoint is all-cause discontinuation; secondary endpoints include psychopathology, cognition, daily functioning, cardiovascular risk factors, and explorative biological measures regarding the underlying mechanisms of exercise. A total of 180 patients will be randomized. With currently 162 randomized participants, our study is the largest trial to date to investigate endurance training in patients with schizophrenia. We hypothesize that aerobic endurance training has beneficial effects on patients’ mental and physical health, leading to lower treatment discontinuation rates and improving disease outcomes. The study results will provide a basis for recommending exercise interventions as an add-on therapy in patients with schizophrenia.The study is registered in the International Clinical Trials Database (ClinicalTrials.gov identifier [NCT number]: NCT03466112) and in the German Clinical Trials Register (DRKS-ID: DRKS00009804).

Digitales Leben in der vernetzten Welt: Chancen und Risiken für die Psychiatrie

“…große Unterschiede. In der psychiatrischen Forschung ist schon länger bekannt, dass leistungsorientiertes Training, wie man es beispielsweise in einem Fitnessstudio vornimmt, positive Effekte auf die psychische Gesundheit und auf hirnbezogene Parameter, wie die Größe des Hippokampus, hat [ 10 ]. Weniger in den Blick genommen, wenn auch vermutlich im Alltagsleben der meisten mindestens ebenso wichtig oder wichtiger, ist jedoch die nichtsportliche Aktivität („non-exercise activity“), also diejenige körperliche Betätigung, die man beim Verfolgen der üblichen Tagesbetätigungen unternimmt.…”

Association between aerobic fitness and the functional connectome in patients with schizophrenia

“…The ESPRIT C3 study is a clinical, randomized-controlled, multicenter trial examining the effects of an aerobic exercise intervention on multiple health outcomes in people with schizophrenia [32]. The current cross-sectional investigation utilized the baseline data of the ESPRIT C3 study prior to intervention onset.…”

“…Patients were diagnosed with schizophrenia in accordance with DSM-IV. For inclusion and exclusion criteria as well as other study details see Maurus et al [32].…”

“…We identified the individual aerobic threshold at lactate concentrations between 1.8 and 2.5 mmol/l according to the previously defined exercise protocol [32]. Achieved wattage at a subject-specific lactate concentration within this range divided by body weight represents individuals´ performance capability at an aerobic exercise intensity.…”

Concept of the Munich/Augsburg Consortium Precision in Mental Health for the German Center of Mental Health

“…The Commission gives recommendations on how to influence this modifiable risk factor, e.g., including regular exercise in treatment plans. For the last 15 years, PriMe researchers have been working along the translational cascade (Figure 3) to better understand the neural effects of physical exercise (10) and to derive novel therapeutic interventions to improve patients' capacity for neural plasticity, reintegration of body and mind functions, and functional recovery (11,12), (WO/2006/120030).…”