Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy.
Center for Sports and Exercise Science, Department of Neuroscience and Rehabilitation, University of Ferrara, Ferrara, Italy.
Aging Clin Exp Res. 2023 May;35(5):1107-1115. doi: 10.1007/s40520-023-02389-9. Epub 2023 Mar 25.
Traditional cardiac rehabilitation (CR) is effective in improving physical performance and prognosis after myocardial infarction (MI). Anyway, it is not consistently recommended to older adults, and its attendance rate is low. Previous studies suggested that alternative, early and tailored exercise interventions are feasible and effective in improving physical performance in older MI patients. Anyway, the demonstration that they are associated also with a significant reduction of hard endpoints is lacking.
To describe rationale and design of the "Physical activity Intervention in Elderly patients with myocardial Infarction" (PIpELINe) trial.
The PIpELINe trial is a prospective, randomized, multicentre study with a blinded adjudicated evaluation of the outcomes. Patients aged ≥ 65 years, admitted to hospital for MI and with a low physical performance one month after discharge, as defined as short physical performance battery (SPPB) value between 4 and 9, will be randomized to a multi-domain lifestyle intervention (including dietary counselling, strict management of cardiovascular and metabolic risk factors, and exercise training) or health education. The primary endpoint is the one-year occurrence of the composite of cardiovascular death or re-hospitalization for cardiovascular causes.
The recruitment started in March 2020. The estimated sample size is 456 patients. The conclusion of the enrolment is planned for mid-2023. The primary endpoint analysis will be available for the end of 2024.
The PIpELINe trial will show if a multi-domain lifestyle intervention is able to reduce adverse events in older patients with reduced physical performance after hospitalization for MI.
ClinicalTrials.gov NCT04183465.
传统心脏康复（CR）在改善心肌梗死后的身体机能和预后方面非常有效。然而，对于老年人来说，它并不总是被推荐，而且其参与率也很低。先前的研究表明，替代的、早期的和量身定制的运动干预在改善老年心肌梗死患者的身体机能方面是可行和有效的。然而，缺乏它们与硬终点显著降低相关的证据。
描述“老年心肌梗死患者体力活动干预”（PIpELINe）试验的原理和设计。
PIpELINe 试验是一项前瞻性、随机、多中心研究，对结果进行盲法评估。年龄≥65 岁、因心肌梗死后住院、出院后一个月身体机能较差的患者（定义为短体适能电池（SPPB）值在 4 到 9 之间）将被随机分配到多领域生活方式干预（包括饮食咨询、严格管理心血管和代谢危险因素以及运动训练）或健康教育。主要终点是一年内心血管死亡或因心血管原因再次住院的复合终点。
该研究于 2020 年 3 月开始招募患者。预计样本量为 456 例患者。计划在 2023 年年中完成入组。主要终点分析将于 2024 年年末进行。
PIpELINe 试验将显示多领域生活方式干预是否能够降低身体机能较差的老年心肌梗死后住院患者的不良事件发生率。
ClinicalTrials.gov NCT04183465。
