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)
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...
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Veröffentlicht in: | European archives of psychiatry and clinical neuroscience 2021-03, Vol.271 (2), p.325-337 |
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creator | Tréhout, Maxime Leroux, Elise Bigot, Lucile Jego, Solenne Leconte, Pascal Reboursière, Emmanuel Morello, Rémy Chapon, Pierre-Alexandre Herbinet, Aline Quarck, Gaëlle Dollfus, Sonia |
description | 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. |
doi_str_mv | 10.1007/s00406-020-01140-z |
format | Article |
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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.</description><identifier>ISSN: 0940-1334</identifier><identifier>EISSN: 1433-8491</identifier><identifier>DOI: 10.1007/s00406-020-01140-z</identifier><identifier>PMID: 32458107</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Adapted physical activity ; Adolescent ; Adult ; Brain - diagnostic imaging ; Brain - metabolism ; Brain - pathology ; Brain - physiopathology ; Brain plasticity ; Circadian rhythm ; Circadian rhythms ; Cognition ; Exercise ; Exercise Therapy ; Female ; Health education ; Humans ; Internet-Based Intervention ; Life Sciences ; Magnetic Resonance Imaging ; Male ; Medicine ; Medicine & Public Health ; Mental disorders ; Middle Aged ; Morbidity ; MRI ; Multicenter Studies as Topic ; Neuroimaging ; Neuronal Plasticity - physiology ; Neurons and Cognition ; Neuroplasticity ; Neurosciences ; Original Paper ; Outcome Assessment, Health Care ; Patient Education as Topic ; Physical activity ; Psychiatric Rehabilitation ; Psychiatry ; Randomized Controlled Trials as Topic ; Schizophrenia ; Schizophrenia - diagnostic imaging ; Schizophrenia - metabolism ; Schizophrenia - physiopathology ; Schizophrenia - rehabilitation ; Telerehabilitation ; Videoconferencing ; Web ; Young Adult</subject><ispartof>European archives of psychiatry and clinical neuroscience, 2021-03, Vol.271 (2), p.325-337</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2020</rights><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2020.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c453t-3bd1f3611f557899150f69473807430b7ea8acdeb4e4f5f481c8ec114a2149603</citedby><cites>FETCH-LOGICAL-c453t-3bd1f3611f557899150f69473807430b7ea8acdeb4e4f5f481c8ec114a2149603</cites><orcidid>0000-0002-6051-1748 ; 0000-0002-1710-2252</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00406-020-01140-z$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00406-020-01140-z$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,780,784,885,27923,27924,41487,42556,51318</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32458107$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://normandie-univ.hal.science/hal-03367199$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Tréhout, Maxime</creatorcontrib><creatorcontrib>Leroux, Elise</creatorcontrib><creatorcontrib>Bigot, Lucile</creatorcontrib><creatorcontrib>Jego, Solenne</creatorcontrib><creatorcontrib>Leconte, Pascal</creatorcontrib><creatorcontrib>Reboursière, Emmanuel</creatorcontrib><creatorcontrib>Morello, Rémy</creatorcontrib><creatorcontrib>Chapon, Pierre-Alexandre</creatorcontrib><creatorcontrib>Herbinet, Aline</creatorcontrib><creatorcontrib>Quarck, Gaëlle</creatorcontrib><creatorcontrib>Dollfus, Sonia</creatorcontrib><title>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)</title><title>European archives of psychiatry and clinical neuroscience</title><addtitle>Eur Arch Psychiatry Clin Neurosci</addtitle><addtitle>Eur Arch Psychiatry Clin Neurosci</addtitle><description>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.</description><subject>Adapted physical activity</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Brain - diagnostic imaging</subject><subject>Brain - metabolism</subject><subject>Brain - pathology</subject><subject>Brain - physiopathology</subject><subject>Brain plasticity</subject><subject>Circadian rhythm</subject><subject>Circadian rhythms</subject><subject>Cognition</subject><subject>Exercise</subject><subject>Exercise Therapy</subject><subject>Female</subject><subject>Health education</subject><subject>Humans</subject><subject>Internet-Based Intervention</subject><subject>Life Sciences</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Mental disorders</subject><subject>Middle Aged</subject><subject>Morbidity</subject><subject>MRI</subject><subject>Multicenter Studies as Topic</subject><subject>Neuroimaging</subject><subject>Neuronal Plasticity - physiology</subject><subject>Neurons and Cognition</subject><subject>Neuroplasticity</subject><subject>Neurosciences</subject><subject>Original Paper</subject><subject>Outcome Assessment, Health Care</subject><subject>Patient Education as Topic</subject><subject>Physical activity</subject><subject>Psychiatric Rehabilitation</subject><subject>Psychiatry</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Schizophrenia</subject><subject>Schizophrenia - diagnostic imaging</subject><subject>Schizophrenia - metabolism</subject><subject>Schizophrenia - physiopathology</subject><subject>Schizophrenia - rehabilitation</subject><subject>Telerehabilitation</subject><subject>Videoconferencing</subject><subject>Web</subject><subject>Young Adult</subject><issn>0940-1334</issn><issn>1433-8491</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9ks-O0zAQxiMEYsvCC3BAlri0h8BMbOcPJ6pVoUiVqLSAxMlyHGfjVRoX2-mqfUveCHdbFsSB01gzv_lmxvqS5CXCGwQo3noABnkKGaSAyCA9PEomyChNS1bh42QCVUwipewieeb9LQAgz-BpckEzxkuEYpL8nJM7Xae19LohspHbEOO223ujZE-kCmZnwp5snb1xckOmOp2v5zOy086PnnRa9qEjuhmVDMYOf3PLxYyYmIkFPQRP7kwkverMwW47pwcjiRyas8Se7Gw_DkFH3XfEh7G5nxmssj1prSOSuEjbjTnE_ZQdgrN9H5_BmbjndL1YX38n395fm9nz5Ekre69fnONl8vXD4svVMl19_vjpar5KFeM0pLRusKU5Yst5UVYVcmjzihW0hIJRqAstS6kaXTPNWt6yElWpVfxmmSGrcqCXyeyk28lebJ3ZSLcXVhqxnK_EMQeU5gVW1Q4jOz2x8aYfo_ZBbIxXuu_loO3oRcagoMgReURf_4Pe2tEN8RKRcUDKy7w6UtmJUs5673T7sAGCOJpDnMwhojnEvTnEITa9OkuP9UY3Dy2_3RABegJ8LA032v2Z_R_ZXzPbxcQ</recordid><startdate>20210301</startdate><enddate>20210301</enddate><creator>Tréhout, Maxime</creator><creator>Leroux, Elise</creator><creator>Bigot, Lucile</creator><creator>Jego, Solenne</creator><creator>Leconte, Pascal</creator><creator>Reboursière, Emmanuel</creator><creator>Morello, Rémy</creator><creator>Chapon, Pierre-Alexandre</creator><creator>Herbinet, Aline</creator><creator>Quarck, Gaëlle</creator><creator>Dollfus, Sonia</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><general>Springer Verlag</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0002-6051-1748</orcidid><orcidid>https://orcid.org/0000-0002-1710-2252</orcidid></search><sort><creationdate>20210301</creationdate><title>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)</title><author>Tréhout, Maxime ; Leroux, Elise ; Bigot, Lucile ; Jego, Solenne ; Leconte, Pascal ; Reboursière, Emmanuel ; Morello, Rémy ; Chapon, Pierre-Alexandre ; Herbinet, Aline ; Quarck, Gaëlle ; Dollfus, Sonia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c453t-3bd1f3611f557899150f69473807430b7ea8acdeb4e4f5f481c8ec114a2149603</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adapted physical activity</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Brain - 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Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>European archives of psychiatry and clinical neuroscience</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tréhout, Maxime</au><au>Leroux, Elise</au><au>Bigot, Lucile</au><au>Jego, Solenne</au><au>Leconte, Pascal</au><au>Reboursière, Emmanuel</au><au>Morello, Rémy</au><au>Chapon, Pierre-Alexandre</au><au>Herbinet, Aline</au><au>Quarck, Gaëlle</au><au>Dollfus, Sonia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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)</atitle><jtitle>European archives of psychiatry and clinical neuroscience</jtitle><stitle>Eur Arch Psychiatry Clin Neurosci</stitle><addtitle>Eur Arch Psychiatry Clin Neurosci</addtitle><date>2021-03-01</date><risdate>2021</risdate><volume>271</volume><issue>2</issue><spage>325</spage><epage>337</epage><pages>325-337</pages><issn>0940-1334</issn><eissn>1433-8491</eissn><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.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>32458107</pmid><doi>10.1007/s00406-020-01140-z</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-6051-1748</orcidid><orcidid>https://orcid.org/0000-0002-1710-2252</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Adapted physical activity Adolescent Adult Brain - diagnostic imaging Brain - metabolism Brain - pathology Brain - physiopathology Brain plasticity Circadian rhythm Circadian rhythms Cognition Exercise Exercise Therapy Female Health education Humans Internet-Based Intervention Life Sciences Magnetic Resonance Imaging Male Medicine Medicine & Public Health Mental disorders Middle Aged Morbidity MRI Multicenter Studies as Topic Neuroimaging Neuronal Plasticity - physiology Neurons and Cognition Neuroplasticity Neurosciences Original Paper Outcome Assessment, Health Care Patient Education as Topic Physical activity Psychiatric Rehabilitation Psychiatry Randomized Controlled Trials as Topic Schizophrenia Schizophrenia - diagnostic imaging Schizophrenia - metabolism Schizophrenia - physiopathology Schizophrenia - rehabilitation Telerehabilitation Videoconferencing Web Young Adult |
title | 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) |
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