Social and Health Care Research Center, Universidad de Castilla-La Mancha, Cuenca, Spain.
Facultad de Fisioterapia y Enfermería, Universidad de Castilla-La Mancha, Toledo, Spain.
BMJ Open. 2020 Jul 8;10(7):e036734. doi: 10.1136/bmjopen-2019-036734.
Despite the consistent evidence of the benefits of physical activity on preventing atherosclerotic cardiovascular diseases (ASCVD) and some cardiovascular risk factors, such as hypertension and dyslipidaemia, the prescription of drugs remains the most widely used approach to prevent ASCVD in clinical settings. The purpose of this study protocol is to provide a meta-synthesis methodology for comparing the effect of fixed-dose combination therapy and physical exercise on controlling cardiovascular risk factors and preventing ASCVD.
This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols and the recommendations of the Cochrane Collaboration Handbook. We plan to conduct a computerised search in Medline, Web of Science, Embase, Cochrane Database of Systematic Reviews and SPORTDiscus from inception to May 2020 for studies testing the effectiveness of physical exercise or fixed-dose combination drug therapy in preventing ASCVD, all-cause and cardiovascular mortality and controlling some cardiovascular risk factors (hypertension and dyslipidaemia). Since performing network meta-analyses (NMA) is a statistical approach that allows direct and indirect comparisons of interventions, where sufficient studies are included, we plan to perform the following NMA comparing the effect of fixed-dose combination therapy and physical exercise interventions on (1) improving lipid profile, (2) reducing blood pressure, (3) preventing cardiovascular events and all-cause and cardiovascular mortality and (4) improving compliance with the therapeutic strategy and reducing adverse events.
Ethical approval will not be needed because data included in the NMA will be extracted from published trials that meet accepted ethical standards. The results will be published in academic peer-reviewed journals, and the evidence gathered by this project could be included in the preventive cardiovascular disease guidelines.
CRD42019122794.
尽管有大量证据表明身体活动有益于预防动脉粥样硬化性心血管疾病（ASCVD）和一些心血管危险因素，如高血压和血脂异常，但在临床实践中，药物仍然是预防 ASCVD 最广泛使用的方法。本研究方案旨在提供一种元综合方法，比较固定剂量联合治疗和身体运动对控制心血管危险因素和预防 ASCVD 的效果。
本方案遵循系统评价和荟萃分析报告的首选项目和 Cochrane 协作手册的建议。我们计划从开始到 2020 年 5 月，在 Medline、Web of Science、Embase、Cochrane 系统评价数据库和 SPORTDiscus 中进行计算机检索，以寻找测试身体运动或固定剂量联合药物治疗预防 ASCVD、全因和心血管死亡率以及控制一些心血管危险因素（高血压和血脂异常）的有效性的研究。由于进行网络荟萃分析（NMA）是一种允许对干预措施进行直接和间接比较的统计方法，如果纳入足够的研究，我们计划进行以下 NMA，比较固定剂量联合治疗和身体运动干预对以下方面的影响：（1）改善血脂谱，（2）降低血压，（3）预防心血管事件和全因和心血管死亡率，（4）提高治疗策略的依从性和减少不良反应。
不需要伦理批准，因为 NMA 中包含的数据将从符合公认伦理标准的已发表试验中提取。结果将发表在学术同行评议期刊上，该项目收集的证据可能被纳入预防心血管疾病指南。
PROSPERO 注册号：CRD42019122794。
