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择期心脏手术患者的康复前随机对照试验。

A randomised controlled trial of prehabilitation in patients undergoing elective cardiac surgery.

机构信息

Academic Cardiovascular Unit, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.

Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne, UK.

出版信息

Anaesthesia. 2023 Sep;78(9):1120-1128. doi: 10.1111/anae.16072. Epub 2023 Jul 4.

DOI:10.1111/anae.16072
PMID:37402352
Abstract

The feasibility, safety and efficacy of prehabilitation in adult patients awaiting elective cardiac surgery are unknown. A total of 180 participants undergoing elective cardiac surgery were allocated randomly to receive either standard pre-operative care or prehabilitation, consisting of pre-operative exercise and inspiratory muscle training. The primary outcome was change in six-minute walk test distance from baseline to pre-operative assessment. Secondary outcomes included change in inspiratory muscle strength (maximal inspiratory pressure); sarcopenia (handgrip strength); quality of life and compliance. Safety outcomes were pre-specified surgical and pulmonary complications and adverse events. All outcomes were assessed at baseline; at pre-operative assessment; and 6 and 12 weeks following surgery. Mean (SD) age was 64.7 (10.2) years; 33/180 (18%) were women. In total, 65/91 (71.4%) participants who were allocated to prehabilitation attended at least four of eight supervised in-hospital exercise classes; participants aged > 50 years were more likely than younger participants to attend (odds ratio (95%CI) of 4.6 (1.0-25.1)). Six-minute walk test was not significantly different between groups (mean difference (95%CI) -7.8 m (-30.6-15.0), p = 0.503) in the intention-to-treat analysis. Subgroup analyses based on tests for interaction indicated improvements in six-minute walk test distance were larger amongst sarcopenic patients in the prehabilitation group (p = 0.004). Change in maximal inspiratory pressure from baseline to all time-points was significantly greater in the prehabilitation group, with the greatest mean difference (95%CI) observed 12 weeks after surgery (10.6 cmH O (4.6-16.6) cmH O, p < 0.001). There were no differences in handgrip strength or quality of life up to 12 weeks after surgery. There was no significant difference in postoperative mortality (one death in each group), surgical or pulmonary complications. Of 71 pre-operative adverse events, six (8.5%) were related to prehabilitation. The combination of exercise and inspiratory muscle training in a prehabilitation intervention before cardiac surgery was not superior to standard care in improving functional exercise capacity measured by six-minute walk test distance pre-operatively. Future trials should target patients living with sarcopenia and include inspiratory muscle strength training.

摘要

在接受择期心脏手术的成年患者中,术前康复的可行性、安全性和疗效尚不清楚。总共 180 名接受择期心脏手术的参与者被随机分配接受标准术前护理或术前康复,包括术前运动和吸气肌训练。主要结局是从基线到术前评估的 6 分钟步行试验距离的变化。次要结局包括吸气肌力量(最大吸气压力);肌肉减少症(握力);生活质量和依从性。预设的手术和肺部并发症及不良事件为安全性结局。所有结局均在基线时、术前评估时以及术后 6 周和 12 周时进行评估。平均(SD)年龄为 64.7(10.2)岁;180 人中有 33 人(18%)为女性。共有 91 名参与者中的 65 名(71.4%)被分配到术前康复组,至少参加了 8 次住院监督锻炼课程中的 4 次;年龄>50 岁的参与者比年轻参与者更有可能参加(优势比(95%CI)为 4.6(1.0-25.1))。意向治疗分析中,两组之间 6 分钟步行试验无显著差异(平均差异(95%CI)为-7.8m(-30.6-15.0),p=0.503)。基于交互检验的亚组分析表明,术前康复组的肌肉减少症患者 6 分钟步行试验距离的改善更大(p=0.004)。从基线到所有时间点的最大吸气压力变化在术前康复组中显著更大,最大平均差异(95%CI)在术后 12 周时观察到(10.6cmH2O(4.6-16.6)cmH2O,p<0.001)。术后 12 周内握力或生活质量无差异。术后死亡率(每组各有 1 例死亡)、手术或肺部并发症无差异。71 例术前不良事件中,有 6 例(8.5%)与术前康复有关。在心脏手术前的术前康复干预中,运动和吸气肌训练的结合在术前改善 6 分钟步行试验距离的功能性运动能力方面并不优于标准护理。未来的试验应针对患有肌肉减少症的患者,并包括吸气肌力量训练。

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