Edorta Elizagarate-Zabala’s research while affiliated with University of Deusto and other places

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Publications (2)


Flow diagram of the TRACE-RMD study
The SPIRIT figure shows an overview of the assessment schedule at baseline and follow-up in the TRACE-RMD study
Treatment with combined exercise in patients with resistant major depression (TRACE-RMD): study protocol for a randomised controlled trial
  • Article
  • Full-text available

December 2024

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35 Reads

Trials

Nagore Iriarte-Yoller

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Cristobal Pavón-Navajas

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Edorta Elizagarate-Zabala

Background 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. Last public release on 12/13/2023.

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Figure 2
Treatment with combined exercise in patients with resistant major depression (TRACE-RMD): study protocol for a randomized clinical trial

August 2024

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16 Reads

Background 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 randomized, single-blind, controlled experimental trial will include 70 adults (≥ 18 years old) with RMD. Participants randomized 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, identifier NCT05136027. Last public release on 12/13/2023