Treatment with combined exercise in patients with resistant major depression (TRACE-RMD): study protocol for a randomised controlled trial

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dc.contributor.authorIriarte Yoller, Nagore
dc.contributor.authorEtxaniz Oses, Jose
dc.contributor.authorPavón Navajas, Cristóbal
dc.contributor.authorTous Espelosín, Mikel
dc.contributor.authorSánchez Gómez, Pedro Manuel
dc.contributor.authorMaldonado-Martín, Sara
dc.contributor.authorYoller Elburgo, Ana Blanca
dc.contributor.authorElizagarate Zabala, Edorta
dc.date.accessioned2025-08-18T08:27:14Z
dc.date.available2025-08-18T08:27:14Z
dc.date.issued2024-12-18
dc.date.updated2025-08-18T08:27:14Z
dc.description.abstractBackground: Around 40% of people with major depressive disorder (MDD) experience moderate remission, with the remainder meeting the criteria for resistant major depression (RMD). It has been shown that exercise has a low-to-moderate effect on MDD, but there is a lack of evidence on exercise interventions in RMD patients. The primary purpose of the proposed study will be to investigate the effect of a 12-week supervised combined exercise program on depressive symptoms in people with RMD compared to a treatment-as-usual (TAU) group. Method: This randomised, single-blind, controlled experimental trial will include 70 adults (≥ 18 years old) with RMD. Participants randomised to an exercise intervention, or a TAU group will be assessed at baseline and after a three-month intervention period. The primary variable will be participants’ depressive symptoms measured with the Montgomery-Asberg Depression Rating Scale. Secondary outcome variables will include cardiorespiratory fitness (peak oxygen uptake through peak cardiopulmonary exercise test), body composition (bioimpedance and anthropometric variables), physical activity level (the International Physical Activity Questionnaire), health-related quality of life (the Short Form-36 Health Survey), functional outcome (the Sheehan Disability Scale and Quality of Life in Depression Scale), overall disease severity (the Clinical Global Impression Scale-Severity of Illness), and biochemical variables (a fasting blood sample). Discussion: This study will try to answer whether a supervised co-adjuvant combined (aerobic and resistance training) exercise program will help the prognosis of this population with RMD. Trial registration: ClinicalTrials.gov NCT05136027.en
dc.description.sponsorshipThis project is funded by the “III Convocatoria Intramural de la Fundación Vital Fundazioa – IIS BIOARABA” and the Mental Health Network of Álavaen
dc.identifier.citationIriarte-Yoller, N., Etxaniz-Oses, J., Pavón-Navajas, C., Tous-Espelosin, M., Sánchez-Gómez, P. M., Maldonado-Martín, S., Yoller-Elburgo, A. B., & Elizagarate-Zabala, E. (2024). Treatment with combined exercise in patients with resistant major depression (TRACE-RMD): study protocol for a randomised controlled trial. Trials, 25(1). https://doi.org/10.1186/S13063-024-08685-7
dc.identifier.doi10.1186/S13063-024-08685-7
dc.identifier.eissn1745-6215
dc.identifier.urihttps://hdl.handle.net/20.500.14454/3367
dc.language.isoeng
dc.publisherBioMed Central Ltd
dc.rights© The Author(s) 2024
dc.subject.otherCombined training
dc.subject.otherExercise
dc.subject.otherQuality of life
dc.subject.otherRandomised controlled trial
dc.subject.otherResistant major depression
dc.titleTreatment with combined exercise in patients with resistant major depression (TRACE-RMD): study protocol for a randomised controlled trialen
dc.typejournal article
dcterms.accessRightsopen access
oaire.citation.issue1
oaire.citation.titleTrials
oaire.citation.volume25
oaire.licenseConditionhttps://creativecommons.org/licenses/by-nc-nd/4.0/
oaire.versionVoR
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