Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)

BDNF; Cytokines; Fibromyalgia

Detalles Bibliográficos
Autores: Serrat, Mayte, Ferrés Puigdevall, Sònia, AUER, WILLIAM, Almirall, Miriam, Lluch, Enrique, D'Amico, Francesco, Lorente Sánchez, Sonia
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:11351/9916
Acceso en línea:https://hdl.handle.net/11351/9916
http://hdl.handle.net/11351/9916
Access Level:acceso abierto
Palabra clave:Fibromiàlgia
Encefalitis
Citocines
DISEASES::Musculoskeletal Diseases::Muscular Diseases::Fibromyalgia
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Nerve Growth Factors::Brain-Derived Neurotrophic Factor
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Cytokines
ENFERMEDADES::enfermedades musculoesqueléticas::enfermedades musculares::fibromialgia
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::factores de crecimiento nervioso::factor neurotrófico derivado del encéfalo
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::citocinas
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network_name_str España
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dc.title.none.fl_str_mv Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)
title Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)
spellingShingle Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)
Serrat, Mayte
Fibromiàlgia
Encefalitis
Citocines
DISEASES::Musculoskeletal Diseases::Muscular Diseases::Fibromyalgia
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Nerve Growth Factors::Brain-Derived Neurotrophic Factor
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Cytokines
ENFERMEDADES::enfermedades musculoesqueléticas::enfermedades musculares::fibromialgia
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::factores de crecimiento nervioso::factor neurotrófico derivado del encéfalo
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::citocinas
title_short Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)
title_full Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)
title_fullStr Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)
title_full_unstemmed Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)
title_sort Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)
dc.creator.none.fl_str_mv Serrat, Mayte
Ferrés Puigdevall, Sònia
AUER, WILLIAM
Almirall, Miriam
Lluch, Enrique
D'Amico, Francesco
Lorente Sánchez, Sonia
author Serrat, Mayte
author_facet Serrat, Mayte
Ferrés Puigdevall, Sònia
AUER, WILLIAM
Almirall, Miriam
Lluch, Enrique
D'Amico, Francesco
Lorente Sánchez, Sonia
author_role author
author2 Ferrés Puigdevall, Sònia
AUER, WILLIAM
Almirall, Miriam
Lluch, Enrique
D'Amico, Francesco
Lorente Sánchez, Sonia
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv [Serrat M] Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain. Escoles Universitàries Gimbernat, Autonomous University of Barcelona, Barcelona, Spain. [Ferrés S] Escoles Universitàries Gimbernat, Autonomous University of Barcelona, Barcelona, Spain. Department of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain. [Auer W] Department of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain. [Almirall M] Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain. [Lluch E] Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Valencia, Spain. Physiotherapy in Motion, Multi-Specialty Research Group (PTinMOTION), Department of Physiotherapy, University of Valencia, Valencia, Spain. Pain in Motion International Research Group, Brussels, Belgium. [D'Amico F] Care Policy and Evaluation Centre (CPEC), London School of Economics and Political Science (LSE), London, United Kingdom. [Lorente S] Servei de Psicobiologia i Metodologia de les Ciències de la Salut, Universitat Autònoma de Barcelona, Barcelona, Spain. Àrea Pediàtrica, PNP, Hospital de Terrassa, Consorci Sanitari de Terrassa, Terrassa, Spain
Consorci Sanitari de Terrassa
dc.subject.none.fl_str_mv Fibromiàlgia
Encefalitis
Citocines
DISEASES::Musculoskeletal Diseases::Muscular Diseases::Fibromyalgia
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Nerve Growth Factors::Brain-Derived Neurotrophic Factor
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Cytokines
ENFERMEDADES::enfermedades musculoesqueléticas::enfermedades musculares::fibromialgia
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::factores de crecimiento nervioso::factor neurotrófico derivado del encéfalo
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::citocinas
topic Fibromiàlgia
Encefalitis
Citocines
DISEASES::Musculoskeletal Diseases::Muscular Diseases::Fibromyalgia
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Nerve Growth Factors::Brain-Derived Neurotrophic Factor
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Cytokines
ENFERMEDADES::enfermedades musculoesqueléticas::enfermedades musculares::fibromialgia
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::factores de crecimiento nervioso::factor neurotrófico derivado del encéfalo
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::citocinas
description BDNF; Cytokines; Fibromyalgia
publishDate 2022
dc.date.none.fl_str_mv 2022
2023
2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/9916
http://hdl.handle.net/11351/9916
url https://hdl.handle.net/11351/9916
http://hdl.handle.net/11351/9916
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Frontiers in Physiology;13
https://doi.org/10.3389/fphys.2022.1046613
dc.rights.none.fl_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Frontiers Media
publisher.none.fl_str_mv Frontiers Media
dc.source.none.fl_str_mv Scientia
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869412234629742592
spelling Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)Serrat, MayteFerrés Puigdevall, SòniaAUER, WILLIAMAlmirall, MiriamLluch, EnriqueD'Amico, FrancescoLorente Sánchez, SoniaFibromiàlgiaEncefalitisCitocinesDISEASES::Musculoskeletal Diseases::Muscular Diseases::FibromyalgiaCHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Nerve Growth Factors::Brain-Derived Neurotrophic FactorCHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::CytokinesENFERMEDADES::enfermedades musculoesqueléticas::enfermedades musculares::fibromialgiaCOMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::factores de crecimiento nervioso::factor neurotrófico derivado del encéfaloCOMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::citocinasBDNF; Cytokines; FibromyalgiaBDNF; Citocinas; FibromialgiaBDNF; Citocines; FibromiàlgiaIntroduction: The On&Out study is aimed at assessing the effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent intervention conducted in two different settings: online (FIBRO-On) or outdoors (FIBRO-Out). Both interventions have proved to be efficacious in the short-term but there is no study assessing their comparative effectiveness nor their long-term effects. For the first time, this study will also evaluate the cost-utility (6-month time-horizon) and the effects on immune-inflammatory biomarkers and Brain-Derived Neurotrophic Factor (BDNF) levels of both interventions. The objectives of this 6-month, randomized, controlled trial (RCT) are 1) to examine the effectiveness and cost-utility of adding FIBRO-On or FIBRO-Out to Treatment-As-Usual (TAU) for individuals with fibromyalgia (FM); 2) to identify pre-post differences in blood biomarker levels in the three study arms and 3) to analyze the role of process variables as mediators of 6-month follow-up clinical outcomes. Methods and analysis: Participants will be 225 individuals with FM recruited at Vall d'Hebron University Hospital (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs. TAU + FIBRO-On vs. TAU + FIBRO-Out. A comprehensive assessment to collect functional impairment, pain, fatigue, depressive and anxiety symptoms, perceived stress, central sensitization, physical function, sleep quality, perceived cognitive dysfunction, kinesiophobia, pain catastrophizing, psychological inflexibility in pain and pain knowledge will be conducted pre-intervention, at 6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immune-inflammatory biomarkers [i.e., IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C-reactive protein (hs-CRP)] and Brain-Derived Neurotrophic Factor will be evaluated in 40 participants in each treatment arm (total n = 120) at pre- and post-treatment. Quality of life and direct and indirect costs will be evaluated at baseline and at 6-month follow-up. Linear mixed-effects regression models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.Frontiers Media[Serrat M] Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain. Escoles Universitàries Gimbernat, Autonomous University of Barcelona, Barcelona, Spain. [Ferrés S] Escoles Universitàries Gimbernat, Autonomous University of Barcelona, Barcelona, Spain. Department of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain. [Auer W] Department of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain. [Almirall M] Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain. [Lluch E] Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Valencia, Spain. Physiotherapy in Motion, Multi-Specialty Research Group (PTinMOTION), Department of Physiotherapy, University of Valencia, Valencia, Spain. Pain in Motion International Research Group, Brussels, Belgium. [D'Amico F] Care Policy and Evaluation Centre (CPEC), London School of Economics and Political Science (LSE), London, United Kingdom. [Lorente S] Servei de Psicobiologia i Metodologia de les Ciències de la Salut, Universitat Autònoma de Barcelona, Barcelona, Spain. Àrea Pediàtrica, PNP, Hospital de Terrassa, Consorci Sanitari de Terrassa, Terrassa, SpainConsorci Sanitari de Terrassa202320232022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/9916http://hdl.handle.net/11351/9916Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésFrontiers in Physiology;13https://doi.org/10.3389/fphys.2022.1046613Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/99162026-05-29T05:05:01Z
score 15,811543

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