Iriarte-Yoller Nagore, Etxaniz-Oses José, Pavón-Navajas Cristobal, Tous-Espelosin Mikel, Sánchez-Gómez Pedro M, Maldonado-Martín Sara, Yoller-Elburgo Ana B, Elizagarate-Zabala Edorta
Osakidetza Basque Health Service, Araba Mental Health Network, Psychiatric Hospital of Alava, Vitoria-Gasteiz, Spain.
Bioaraba, New Therapies in Mental Health Group, Vitoria-Gasteiz, Spain.
Trials. 2024 Dec 18;25(1):827. doi: 10.1186/s13063-024-08685-7.
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.
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).
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.
ClinicalTrials.gov NCT05136027. Last public release on 12/13/2023.
约40%的重度抑郁症（MDD）患者经历中度缓解，其余患者符合难治性重度抑郁症（RMD）的标准。研究表明，运动对MDD有低至中度的影响，但缺乏关于RMD患者运动干预的证据。拟进行的这项研究的主要目的是，与常规治疗（TAU）组相比，调查一项为期12周的有监督的联合运动计划对RMD患者抑郁症状的影响。
这项随机、单盲、对照实验性试验将纳入70名年龄≥18岁的RMD成年患者。随机分配至运动干预组或TAU组的参与者将在基线时以及三个月的干预期后接受评估。主要变量将是用蒙哥马利-阿斯伯格抑郁评定量表测量的参与者抑郁症状。次要结果变量将包括心肺适能（通过峰值心肺运动试验测得的峰值摄氧量）、身体成分（生物电阻抗和人体测量变量）、身体活动水平（国际身体活动问卷）、健康相关生活质量（简明健康状况调查36项量表）、功能结局（希恩残疾量表和抑郁生活质量量表）、总体疾病严重程度（临床总体印象量表-疾病严重程度）以及生化变量（空腹血样）。
本研究将试图回答一项有监督的联合辅助（有氧和抗阻训练）运动计划是否有助于改善这群RMD患者的预后。
ClinicalTrials.gov NCT05136027。最后一次公开更新于2023年12月13日。
