Neves Lucas Melo, Silva-Batista Carla, Marquesini Raquel, da Cunha Telma Fátima, Dimateo Elisa, Nascimento Luciana, Moreira-Neto Acácio, de Lima Miliatto Angelo Corrêa, das Chagas Mendes Sheila, Saad Flavia, Codogno Jamile Sanches, Nunes Renato Hoffmann, Ritti-Dias Raphael Mendes, Juday Valeria, Lafer Beny, Ugrinowitsch Carlos
School of Physical Education and Sport, University of São Paulo (EEFE-USP), São Paulo, Brazil.
Universidade Paulista (UNIP), São Paulo, Brazil.
Trials. 2018 Oct 10;19(1):545. doi: 10.1186/s13063-018-2906-y.
Patients with major depression disorder presents increased rates of cognitive decline, reduced hippocampal volume, poor sleep quality, hypertension, obesity, suicidal ideation and behavior, and decreased functionality. Although continuous aerobic exercise (CAE) improves some of the aforementioned symptoms, comorbidities, and conditions, recent studies have suggested that performing aerobic exercise with motor complexity (AEMC) may be more beneficial for cognitive decline, hippocampal volume, and functionality. Therefore, this randomized controlled trial will compare the effects of CAE and AEMC on depression score, cognitive function, hippocampal volume, brain-derived neurotrophic factor expression, sleep parameters, cardiovascular risk parameters, suicidal behavior, functionality, and treatment costs in patients with depression.
METHODS/DESIGN: Seventy-five medicated patients with depression will be recruited from a Basic Healthcare Unit to participate in this prospective, parallel group, single blinded, superiority, randomized controlled trial. Patients with depression according to DSM-V criteria will be balanced and randomly assigned (based on depression scores and number of depressive episodes) to a non-exercising control (C), CAE, and AEMC groups. The CAE and AEMC groups will exercise for 60 min, twice a week for 24 weeks (on non-consecutive days). Exercise intensity will be maintained between 12 and 14 points of the rating of perceived exertion scale (~ 70-80% of the maximum heart rate). The CAE group will perform a continuous aerobic exercise while the AEMC group will perform exercises with progressively increased motor complexity. Blinded raters will assess patients before and after the intervention period. The primary outcome measure will be the change in depression score measured by the Montgomery-Asberg Depression Rating Scale. Secondary outcomes will include measures of cognitive function, hippocampal volume, brain-derived neurotrophic factor expression, sleep parameters, cardiovascular risk parameters, suicidal behavior, functionality, and treatment costs.
This study was selected in the call of public policy programs for the Brazilian Unified National Health System - "PPSUS 2015". To our knowledge, this is the first pragmatic trial to test the effect of adding AEMC to the pharmacological treatment of patients with depression and to evaluate the possible reductions in depression symptoms and healthcare costs.
Brazilian Clinical Trials Registry (ReBec) - RBR-9zgxzd - Registered on 4 Jan. 2017.
重度抑郁症患者出现认知衰退率增加、海马体体积减小、睡眠质量差、高血压、肥胖、自杀意念和行为以及功能下降等情况。尽管持续有氧运动（CAE）可改善上述部分症状、合并症和状况，但最近的研究表明，进行具有运动复杂性的有氧运动（AEMC）可能对认知衰退、海马体体积和功能更有益。因此，这项随机对照试验将比较CAE和AEMC对抑郁症患者的抑郁评分、认知功能、海马体体积、脑源性神经营养因子表达、睡眠参数、心血管风险参数、自杀行为、功能以及治疗成本的影响。
方法/设计：将从一个基层医疗单位招募75名正在接受药物治疗的抑郁症患者，参与这项前瞻性、平行组、单盲、优效性随机对照试验。根据《精神疾病诊断与统计手册》第五版（DSM-V）标准诊断为抑郁症的患者将进行均衡分组，并随机分配（基于抑郁评分和抑郁发作次数）至非运动对照组（C组）、CAE组和AEMC组。CAE组和AEMC组将每周进行两次60分钟的运动，持续24周（非连续日）。运动强度将维持在自感用力度量表的12至14分之间（约为最大心率的70%-80%）。CAE组将进行持续有氧运动，而AEMC组将进行运动复杂性逐步增加的运动。盲法评估人员将在干预期前后对患者进行评估。主要结局指标将是用蒙哥马利-阿斯伯格抑郁评定量表测量的抑郁评分变化。次要结局指标将包括认知功能、海马体体积、脑源性神经营养因子表达、睡眠参数、心血管风险参数、自杀行为、功能以及治疗成本的测量指标。
本研究入选了巴西统一国家卫生系统的公共政策项目号召——"2015年PPSUS"。据我们所知，这是第一项检验在抑郁症患者药物治疗中加入AEMC的效果以及评估抑郁症状和医疗成本可能降低情况的实用性试验。
巴西临床试验注册中心（ReBec）- RBR-9zgxzd - 于2017年1月4日注册。
