Abstract
Patients with schizophrenia (SZ) have a high level of cardiovascular morbidity and some clinical symptoms of illness remain resistant to pharmacological approaches. A large number of studies support the effectiveness of physical activity (PA) in SZ. The aims of this trial is to assess the effects of a remote, web-based adapted PA program (e-APA) compared to a health education program (e-HE) on brain plasticity in SZ and healthy volunteers (HV) and on psychiatric, neurocognitive, circadian and physical variables. The study is an interventional, multicenter, randomized open-label trial. Forty-two SZ will be randomized to either the active group (e-APA, N = 21) or nonactive group (e-HE, N = 21), and 21 HV will be matched to SZ according to age, gender, and level of PA in both e-APA and e-HE groups. Interventions will consist of 32 sessions (2 × 60 min/week, for 16 weeks) via supervised home-based videoconferencing. Cerebral magnetic resonance imaging, psychiatric symptoms, neurocognitive and circadian rhythms assessments as well as physical tests and biological analyses will be assessed at baseline and 16 weeks after the intervention. To our knowledge, this is the first study aiming to evaluate the efficacy of APA delivered by supervised home-based videoconferencing in SZ. Moreover, using multimodal MRI, this study could clarify the pathophysiological mechanisms underlying the efficacy of APA. Finally, this innovative approach might also increase participation in long-term PA since PA-based programs are known to have low adherence and early dropout. Trial registration: ClinicalTrials.gov identifier: NCT03261817. Registered on 16 August 2017.
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Acknowledgements
We thank the DRCI (Délégation à la Recherche Clinique et à l’Innovation) and CRC (Centre de Recherche Clinique) staffs for their contribution to the study conception and for the promotion and management of the protocol proceedings. We also thank Pr Olivier Guillin from the University Hospital of Rouen and all associated investigators for their clinical contributions. We thank collaborators from GIP Cyceron, Nicolas Delcroix for MRI sequences, Frédéric Briend for MRI spectroscopy sequence and assessments, Mickael Naveau for the database, and Gaëlle Chetelat and Robin de Flores for hippocampal sequence. We thank Drs Perrine Brazo, Sophie Meunier-Cussac, Aurélie Montagne, Pierrick Lebain, Anaïs Vandevelde, for patient recruitment. Finally, we thank patients and healthy volunteers for their upcoming participation in the study.
Funding
The PEPSY European project is co-funded by the Normandy County Council, European Union in the framework of the ERDF-ESF operational program 2014–2020. This work was also supported by the Fondation Pierre Deniker. Funding sources were not involved in the study design, the collection, analysis and interpretation of data, the writing of the report, or the decision to submit the paper for publication.
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Authors and Affiliations
Contributions
MT: participation in HE program conception and dispensation, subject recruitment, participant assessments, MRI assessments, data analysis, and manuscript drafting and revision. EL: HE program conception and dispensation, subject recruitment, MRI assessments, imaging pre- and postprocessing, data analysis, neurocognitive assessments, and manuscript revision. SJ: HE program conception and dispensation and neurocognitive assessments. PL: methods on the evaluation of APA. LB: APA video conferencing and SAPATIC platform management, participation in HE and APA program conception, and manuscript revision. AH: study conception and design, APA program conception, and SAPATIC platform conception and management. ER: exercise test dispensation. RM: methodological conception and manuscript revision. PAC: e-Celcius and Zephyr BioHarness® management. GQ: study conception and design, circadian data analysis, and manuscript revision. SD: study conception and design, principal investigator, patient recruitment, participant assessments, MRI assessments, data analysis, and manuscript revision. All authors have read and approved the final manuscript.
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Conflict of interest
MT participated in educational conferences for the following industrial laboratories: Otsuka, Lundbeck, and Janssen. SD has been an expert and consultant or participated in educational conferences for the following industrial laboratories or companies: Gedeon Richter, Lundbeck Otsuka, Roche, Takeda, Fabre, Janssen, ONO Pharma and Verasci. She also has a license agreement on SNS with MedAvante-ProPhase. EL, SJ, PL, ER, RM and GQ have no competing conflicts. AH is the manager of the V@Si company, and LB is employed by V@Si. PA is employed by Bodycap Company.
Ethical approval
The protocol was submitted to the French Health Authority, namely, the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), for formal approval to conduct the study conduct and to ensure that the study meets the local regulations of a properly constituted Ethics Committee. The project was approved by Health Authorities (ANSM) on 19 July 2016 (ID-RCB number 2016-A00930-51) and by the local ethical committee (Comité de Protection des Personnes, CPP Nord-Ouest IV, France) on 10 January 2017 in compliance with French regulations. The trial was registered at ClinicalTrial.gov on 25 August 2017 (NCT03261817). Initial information about the study is given to eligible participants by the regular staff during a routine appointment or by coworkers. Further detailed written and oral information about the trial are then provided by the project coworker. Voluntary participation is assured, and participants can withdraw at any time and receive standard treatment regardless of whether they choose to participate. Each participant provides written informed consent before any intervention is started.
Trial status
The current PEPSYV@SI protocol version is 5 dated 6 March 2018. The first participant was recruited in September 2017, and the study is currently enrolling participants. The study is expected to be completed in December 2021.
Additional information
Communicated by Peter Falkai.
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Tréhout, M., Leroux, E., Bigot, L. et al. A web-based adapted physical activity program (e-APA) versus health education program (e-HE) in patients with schizophrenia and healthy volunteers: study protocol for a randomized controlled trial (PEPSY V@Si). Eur Arch Psychiatry Clin Neurosci 271, 325–337 (2021). https://doi.org/10.1007/s00406-020-01140-z
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DOI: https://doi.org/10.1007/s00406-020-01140-z