BACKGROUND Postoperative morbidity can reduce quality of life, physical performance, and tolerability of postoperative chemotherapy in patients with colorectal liver metastases (CRLM). Exercise can improve these outcomes in some cancer populations. However, it remains unknown whether exercise can be delivered in the early postoperative period following surgery for CRLM without increasing the risk of harms. OBJECTIVE The primary objective was to compare the number of serious adverse events (SAEs) with exercise intervention versus control. The secondary objectives were to compare non-SAEs, chemotherapy dose modifications, patient-reported outcomes, cardiorespiratory fitness, and physical performance. METHODS Patients with CRLM scheduled to open surgery with or without postoperative chemotherapy were randomized 2:1 to intervention or control. The intervention group performed 30-50 min low-to-high intensity exercise 5 times/week for 8 weeks, initiated one day after postoperative hospital discharge. The primary outcome was SAEs. The secondary outcomes were SAEs; chemotherapy dose modifications; patient-reported outcomes; cardiorespiratory fitness; and physical performance. RESULTS Fifty-five participants were randomized. The number of SAEs was similar between the groups (between-group difference [95% CI]: -0.07 [-0.59; 0.43] events), whereas the number of non-SAEs was lower in intervention (between-group difference [95% CI]: -4.65 [-9.14; -0.17] events). We found between-group differences in time to postoperative chemotherapy (intervention: 25 days, control; 42 days) and chemotherapy dose modifications (RR [95%CI]: 0.55 [0.35; 0.88]). Additionally, we found between-group differences in quality of life, cardiorespiratory fitness, and physical performance, in favor of intervention. CONCLUSIONS Early-onset postoperative exercise exhibit a favorable harms-benefit profile in patients with CRLM. This warrants further investigation in larger randomized controlled trials. TRIAL REGISTRATION Prospectively registered at clinicaltrials.gov (NCT04751773).

中文翻译：

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结直肠肝转移患者的术后运动训练：一项随机对照试验。


背景 术后发病率会降低结直肠肝转移 （CRLM） 患者的生活质量、身体机能和术后化疗的耐受性。运动可以改善某些癌症人群的这些结果。然而，目前尚不清楚是否可以在 CRLM 手术后的早期进行锻炼而不增加伤害风险。目的 主要目的是比较运动干预组与对照组的严重不良事件 （SAE） 数量。次要目标是比较非 SAE 、化疗剂量调整、患者报告的结局、心肺健康和身体机能。方法 计划开放手术联合或不联合术后化疗的 CRLM 患者以 2：1 的比例随机分配到干预组或对照组。干预组进行 30-50 分钟的低强度到高强度运动，每周 5 次，持续 8 周，术后出院后 1 天开始。主要结局是 SAEs。次要结局是 SAEs;化疗剂量调整;患者报告的结果;心肺适能;和身体表现。结果 55 名参与者被随机分组。两组间 SAE 的数量相似 （组间差异 [95% CI]： -0.07 [-0.59;0.43] 事件），而干预中非 SAE 的数量较低 （组间差异 [95% CI]： -4.65 [-9.14;-0.17] 事件）。我们发现术后化疗时间 （干预： 25 天，对照;42 天） 和化疗剂量调整 （RR [95%CI]： 0.55 [0.35; 0.88]）的组间差异。 此外，我们发现生活质量、心肺健康和身体机能的组间差异有利于干预。结论 早起性术后锻炼在 CRLM 患者中表现出良好的利弊特征。这值得在更大规模的随机对照试验中进行进一步研究。试验注册 前瞻性注册 clinicaltrials.gov （NCT04751773）。