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. 2021 Mar;271(2):315-324.
doi: 10.1007/s00406-020-01175-2. Epub 2020 Aug 3.

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

Isabel Maurus  1 , Alkomiet Hasan  2   3 , Andrea Schmitt  2   4 , Astrid Roeh  2 , Daniel Keeser  2   5 , Berend Malchow  6 , Thomas Schneider-Axmann  2 , Martin Hellmich  7 , Sabine Schmied  8 , Moritz Lembeck  2 , Katriona Keller-Varady  9 , Irina Papazova  2 , Dusan Hirjak  10 , Cristina E Topor  10 , Henrik Walter  11 , Sebastian Mohnke  11 , Bob O Vogel  11 , Wolfgang Wölwer  12 , Frank Schneider  13   14 , Karsten Henkel  14 , Andreas Meyer-Lindenberg #  10 , Peter Falkai #  2
Affiliations

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

Isabel Maurus et al. Eur Arch Psychiatry Clin Neurosci. 2021 Mar.

Erratum in

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).

Keywords: Cognition; Exercise; Physical activity; Randomized clinical trial; Recovery; Schizophrenia.

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Conflict of interest statement

AH is co-editor of the German (DGPPN) schizophrenia treatment guidelines and first author of the WFSBP schizophrenia treatment guidelines; he has been on the advisory boards and has received speaker fees from Janssen-Cilag, Lundbeck, and Otsuka. AS was an honorary speaker for TAD Pharma and Roche and a member of Roche advisory boards. PF is a co-editor of the German (DGPPN) schizophrenia treatment guidelines and a co-author of the WFSBP schizophrenia treatment guidelines; he is on the advisory boards and receives speaker fees from Janssen, Lundbeck, Otsuka, Servier, and Richter. AML has received consultant fees from Boehringer Ingelheim, Elsevier, Brainsway, Lundbeck Int. Neuroscience Foundation, Lundbeck A/S, Sumitomo Dainippon Pharma Co., Academic Medical Center of the University of Amsterdam, Synapsis Foundation-Alzheimer Research Switzerland, IBS Center for Synaptic Brain Dysfunction, Blueprint Partnership, University of Cambridge, Dt. Zentrum für Neurodegenerative Erkrankungen, Zürich University, Brain Mind Institute, L.E.K. Consulting, ICARE Schizophrenia, Science Advances, Fondation FondaMental, v Behring Röntgen Stiftung, The Wolfson Foundation, and Sage Therapeutics; Additionally, he has received speaker fees from Lundbeck International Foundation, Paul-Martini-Stiftung, Lilly Deutschland, Atheneum, Fama Public Relations, Institut d'investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Janssen-Cilag, Hertie Stiftung, Bodelschwingh-Klinik, Pfizer, Atheneum, University of Freiburg, Schizophrenia Academy, Hong Kong Society of Biological Psychiatry, Fama Public Relations, Spanish Society of Psychiatry, Italian Society of Biological Psychiatry, Reunions I Ciencia S.L., and Brain Center Rudolf Magnus UMC Utrecht, as well as the Prix Roger de Spoelberch grant and the CINP Lilly Neuroscience Clinical Research Award 2016. IM, ML, IP, AR, DK, CT, DH, SM, BV, WW, TSA, FS, KH, KK, SS, MH, BM, and HW report no conflicts of interest.

Figures

Fig. 1
Fig. 1
Flowchart of the study design I
Fig. 2
Fig. 2
Flowchart of the study design II
See this image and copyright information in PMC

Comment in

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