Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-Exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program

Introduction: Recent studies have shown that symptoms of psychiatric illness, functionality, and cognitive function improve with exercise. The aim of this study will be to investigate whether the implementation of an individualized exercise program will improve the functional status of patients with...

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Main Authors: Saínza García, Ilargi Gorostegi-Anduaga, Edurne García-Corres, Sara Maldonado-Martín, Karina S. MacDowell, Cristina Bermúdez-Ampudia, María J. Apodaca, Irene Pérez-Landaluce, Ignacio Tobalina-Larrea, Juan C. Leza, A. González-Pinto
Format: Article
Language:English
Published: Frontiers Media S.A. 2020-10-01
Series:Frontiers in Psychiatry
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fpsyt.2020.568455/full
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author Saínza García
Saínza García
Saínza García
Saínza García
Ilargi Gorostegi-Anduaga
Ilargi Gorostegi-Anduaga
Edurne García-Corres
Edurne García-Corres
Edurne García-Corres
Sara Maldonado-Martín
Sara Maldonado-Martín
Karina S. MacDowell
Karina S. MacDowell
Cristina Bermúdez-Ampudia
María J. Apodaca
Irene Pérez-Landaluce
Ignacio Tobalina-Larrea
Ignacio Tobalina-Larrea
Juan C. Leza
Juan C. Leza
A. González-Pinto
A. González-Pinto
A. González-Pinto
A. González-Pinto
author_facet Saínza García
Saínza García
Saínza García
Saínza García
Ilargi Gorostegi-Anduaga
Ilargi Gorostegi-Anduaga
Edurne García-Corres
Edurne García-Corres
Edurne García-Corres
Sara Maldonado-Martín
Sara Maldonado-Martín
Karina S. MacDowell
Karina S. MacDowell
Cristina Bermúdez-Ampudia
María J. Apodaca
Irene Pérez-Landaluce
Ignacio Tobalina-Larrea
Ignacio Tobalina-Larrea
Juan C. Leza
Juan C. Leza
A. González-Pinto
A. González-Pinto
A. González-Pinto
A. González-Pinto
author_sort Saínza García
collection DOAJ
description Introduction: Recent studies have shown that symptoms of psychiatric illness, functionality, and cognitive function improve with exercise. The aim of this study will be to investigate whether the implementation of an individualized exercise program will improve the functional status of patients with bipolar disorder (BD).Methods: This longitudinal, interventional, randomized, controlled, simple-blind clinical trial will include 80 patients aged 18–65 years, all of them with BD diagnosis. Patients will be randomly assigned to a physical exercise intervention + Treatment-As-Usual (TAU) group and a non-intervention + TAU group. Patients will be assessed by an extensive battery of clinical tests, physical parameters (e.g., brain structure changes measured by optical coherence tomography, cardiorespiratory fitness) and biological parameters (inflammation, oxidative stress and neurotrophic factors) at baseline, after a 4-month intervention period, and 6-month follow-up.Discussion: This is an innovative study aimed at gaining a deeper understanding of the physiopathology of BD and determining whether the prognosis and evolution of the disease can be improved through modifiable areas of the patient's lifestyle.Clinical Trial Registration: NCT04400630. NCT clinicaltrials.gov. Date of registration in primary registry 22 May 2020. clinicaltrials.gov.
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spelling doaj.art-b700a4e4769142f7a875ba43998080362022-12-22T03:00:01ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402020-10-011110.3389/fpsyt.2020.568455568455Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-Exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist ProgramSaínza García0Saínza García1Saínza García2Saínza García3Ilargi Gorostegi-Anduaga4Ilargi Gorostegi-Anduaga5Edurne García-Corres6Edurne García-Corres7Edurne García-Corres8Sara Maldonado-Martín9Sara Maldonado-Martín10Karina S. MacDowell11Karina S. MacDowell12Cristina Bermúdez-Ampudia13María J. Apodaca14Irene Pérez-Landaluce15Ignacio Tobalina-Larrea16Ignacio Tobalina-Larrea17Juan C. Leza18Juan C. Leza19A. González-Pinto20A. González-Pinto21A. González-Pinto22A. González-Pinto23Severe Mental Illness Research Group, Bioaraba Health Research Institute, Vitoria-Gasteiz, SpainDepartment of Psychiatry, Osakdietza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, SpainCentre for Biomedical Research Network on Mental Health (CIBERSAM), Madrid, SpainSchool of Medicine, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, SpainDepartment of Physical Education and Sport, Faculty of Education and Sport, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, SpainGIzartea, Kirola eta Ariketa Fisikoa Ikerkuntza Taldea (GIKAFIT), Society, Sports, and Physical Exercise Research Group, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, SpainSevere Mental Illness Research Group, Bioaraba Health Research Institute, Vitoria-Gasteiz, SpainDepartment of Psychiatry, Osakdietza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, SpainSchool of Medicine, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, SpainDepartment of Physical Education and Sport, Faculty of Education and Sport, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, SpainGIzartea, Kirola eta Ariketa Fisikoa Ikerkuntza Taldea (GIKAFIT), Society, Sports, and Physical Exercise Research Group, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, SpainCentre for Biomedical Research Network on Mental Health (CIBERSAM), Madrid, SpainDepartment of Pharmacology and Toxicology, Faculty of Medicine, Complutense University of Madrid, Madrid, SpainEpidemiology and Public Health Research Group, Bioaraba Health Research Institute, Vitoria-Gasteiz, SpainDepartment of Cardiology, Osakdietza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, Spain0Department of Ophthalmology, Osakdietza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, SpainSchool of Medicine, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Spain1Department of Nuclear Medicine, Osakdietza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, SpainCentre for Biomedical Research Network on Mental Health (CIBERSAM), Madrid, SpainDepartment of Pharmacology and Toxicology, Faculty of Medicine, Complutense University of Madrid, Madrid, SpainSevere Mental Illness Research Group, Bioaraba Health Research Institute, Vitoria-Gasteiz, SpainDepartment of Psychiatry, Osakdietza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, SpainCentre for Biomedical Research Network on Mental Health (CIBERSAM), Madrid, SpainSchool of Medicine, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, SpainIntroduction: Recent studies have shown that symptoms of psychiatric illness, functionality, and cognitive function improve with exercise. The aim of this study will be to investigate whether the implementation of an individualized exercise program will improve the functional status of patients with bipolar disorder (BD).Methods: This longitudinal, interventional, randomized, controlled, simple-blind clinical trial will include 80 patients aged 18–65 years, all of them with BD diagnosis. Patients will be randomly assigned to a physical exercise intervention + Treatment-As-Usual (TAU) group and a non-intervention + TAU group. Patients will be assessed by an extensive battery of clinical tests, physical parameters (e.g., brain structure changes measured by optical coherence tomography, cardiorespiratory fitness) and biological parameters (inflammation, oxidative stress and neurotrophic factors) at baseline, after a 4-month intervention period, and 6-month follow-up.Discussion: This is an innovative study aimed at gaining a deeper understanding of the physiopathology of BD and determining whether the prognosis and evolution of the disease can be improved through modifiable areas of the patient's lifestyle.Clinical Trial Registration: NCT04400630. NCT clinicaltrials.gov. Date of registration in primary registry 22 May 2020. clinicaltrials.gov.https://www.frontiersin.org/articles/10.3389/fpsyt.2020.568455/fullbipolar disorderphysical exerciseintervention programneurocognitionfunctional capacity
spellingShingle Saínza García
Saínza García
Saínza García
Saínza García
Ilargi Gorostegi-Anduaga
Ilargi Gorostegi-Anduaga
Edurne García-Corres
Edurne García-Corres
Edurne García-Corres
Sara Maldonado-Martín
Sara Maldonado-Martín
Karina S. MacDowell
Karina S. MacDowell
Cristina Bermúdez-Ampudia
María J. Apodaca
Irene Pérez-Landaluce
Ignacio Tobalina-Larrea
Ignacio Tobalina-Larrea
Juan C. Leza
Juan C. Leza
A. González-Pinto
A. González-Pinto
A. González-Pinto
A. González-Pinto
Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-Exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program
Frontiers in Psychiatry
bipolar disorder
physical exercise
intervention program
neurocognition
functional capacity
title Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-Exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program
title_full Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-Exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program
title_fullStr Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-Exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program
title_full_unstemmed Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-Exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program
title_short Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-Exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program
title_sort functionality and neurocognition in patients with bipolar disorder after a physical exercise program finext bd study protocol of a randomized interventionist program
topic bipolar disorder
physical exercise
intervention program
neurocognition
functional capacity
url https://www.frontiersin.org/articles/10.3389/fpsyt.2020.568455/full
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