Department of Medicine, Division of Geriatric Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.
Department of Epidemiology and Biostatistics, Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.
BMC Geriatr. 2018 Apr 16;18(1):93. doi: 10.1186/s12877-018-0782-7.
BACKGROUND: Physical exercise, cognitive training, and vitamin D are low cost interventions that have the potential to enhance cognitive function and mobility in older adults, especially in pre-dementia states such as Mild Cognitive Impairment (MCI). Aerobic and progressive resistance exercises have benefits to cognitive performance, though evidence is somewhat inconsistent. We postulate that combined aerobic exercise (AE) and progressive resistance training (RT) (combined exercise) will have a better effect on cognition than a balance and toning control (BAT) intervention in older adults with MCI. We also expect that adding cognitive training and vitamin D supplementation to the combined exercise, as a multimodal intervention, will have synergistic efficacy. METHODS: The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition) is a multi-site, double-blinded, five-arm, controlled trial that assesses the potential synergic effect of combined AE and RT on cognition and mobility, with and without cognitive training and vitamin D supplementation in older adults with MCI. Two-hundred participants with MCI aged 60 to 85 years old will be randomized to one of five arms, four of which include combined exercise plus combinations of dual-task cognitive training (real vs. sham) and vitamin D supplementation (3 × 10,000 IU/wk. vs. placebo) in a quasi-factorial design, and one arm which receives all control interventions. The primary outcome measure is the ADAS-Cog (13 and plus modalities) measured at baseline and at 6 months of follow-up. Secondary outcomes include neuroimaging, neuro-cognitive performance, gait and mobility performance, and serum biomarkers of inflammation (C reactive protein and interleukin 6), neuroplasticity (brain-derived neurotropic factor), endothelial markers (vascular endothelial growth factor 1), and vitamin D serum levels. DISCUSSION: The SYNERGIC Trial will establish the efficacy and feasibility of a multimodal intervention to improve cognitive performance and mobility outcomes in MCI. These interventions may contribute to new approaches to stabilize and reverse cognitive-mobility decline in older individuals with MCI. TRIAL REGISTRATION: Identifier: NCT02808676. https://www.clinicaltrials.gov/ct2/show/NCT02808676 .
背景：体育锻炼、认知训练和维生素 D 是低成本的干预措施，有可能提高老年人的认知功能和活动能力，尤其是在轻度认知障碍 (MCI) 等痴呆前状态下。有氧运动和渐进式抗阻训练对认知表现有好处，但证据有些不一致。我们假设，与平衡和调谐控制 (BAT) 干预相比，有氧运动 (AE) 和渐进式抗阻训练 (RT) 的联合运动 (联合运动) 将对 MCI 老年人的认知有更好的效果。我们还预计，将认知训练和维生素 D 补充剂添加到联合运动中作为一种多模式干预措施，将具有协同疗效。
方法：SYNERGIC 试验 (同步运动、步态和认知的治疗) 是一项多地点、双盲、五臂、对照试验，评估联合 AE 和 RT 对认知和活动能力的潜在协同作用，以及在认知训练和维生素 D 补充剂的情况下，在 MCI 老年人中是否具有协同作用。200 名年龄在 60 至 85 岁之间的 MCI 老年人将被随机分配到五个手臂中的一个，其中四个手臂包括联合运动加双重任务认知训练 (真实与假) 和维生素 D 补充剂 (3×10,000IU/周。与安慰剂) 在准因子设计中，一个手臂接受所有对照干预。主要观察指标是基线和 6 个月随访时的 ADAS-Cog(13 和加模式)。次要结果包括神经影像学、神经认知表现、步态和活动能力以及炎症的血清生物标志物 (C 反应蛋白和白细胞介素 6)、神经可塑性 (脑源性神经营养因子)、内皮标志物 (血管内皮生长因子 1) 和维生素 D 血清水平。
讨论：SYNERGIC 试验将确定一种多模式干预措施的疗效和可行性，以改善 MCI 患者的认知表现和活动能力。这些干预措施可能有助于为稳定和逆转认知-运动能力下降提供新方法 MCI 中老年人。
试验注册：标识符：NCT02808676。https://www.clinicaltrials.gov/ct2/show/NCT02808676。
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