Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-Exercise Program (Finext-BD Study)

Protocol of a Randomized Interventionist Program

Bibliographic Data

ID15526323
AuthorsSainza García (BioCruces Health research Institute), Ilargi Gorostegi-Anduaga (0000-0002-1571-8408, University of the Basque Country), Edurne García-Corres (University of the Basque Country), Sara Maldonado‐Martín (0000-0002-2622-5385, University of the Basque Country), Karina S MacDowell (0000-0002-1527-8895, Centre for Biomedical Network Research on Rare Diseases), Cristina Bermúdez‐Ampudia (0000-0003-4823-2225, BioCruces Health research Institute), María José Fuster-Ruiz de Apodaca (Hospital Universitario Araba), Irene Pérez-Landaluce (Hospital Universitario Araba), Ignacio Tobalina-Larrea (Hospital Universitario Araba), Juan C Leza (0000-0002-9901-0094, Centre for Biomedical Network Research on Rare Diseases), Ana González‐Pinto (0000-0002-2568-5179, Hospital Universitario Araba, corresponding author)
Year2020
Volume11
Pages568455-568455
Publication date2020-10-29
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueFrontiers in Psychiatry (JOURNAL)
Journal identifiersISSN: 1664-0640 • E-ISSN: 1664-0640
PublisherFrontiers Media (PUBLISHER • CH)
DOI10.3389/fpsyt.2020.568455
PMID33240125
OpenAlexW3096444941
LanguageEN
Citations received1
References cited11

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

Alternative medicine · Cardiorespiratory fitness · Clinical trial · Cognition · Geriatric psychiatry · Informed consent · Intervention (counseling · Neurocognitive · Neuropsychology · Pathology · Physical therapy · Protocol (science · Psychiatry · Randomized controlled trial · Bipolar Disorder and Treatment · Electroconvulsive Therapy Studies · Medicine · Tryptophan and brain disorders · Internal Medicine