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乳腺癌手术后按照推荐的术前和术后体力活动康复:(PhysSURG-B)随机临床试验。

Recovery after breast cancer surgery following recommended pre and postoperative physical activity: (PhysSURG-B) randomized clinical trial.

机构信息

Scandinavian Surgical Outcomes Research Group (SSORG), Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Region Västra Götaland, Sahlgrenska Breast Centre, Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.

出版信息

Br J Surg. 2021 Jan 27;108(1):32-39. doi: 10.1093/bjs/znaa007.

Abstract

BACKGROUND

The effect of preoperative physical activity on recovery and complications after primary breast cancer surgery is unknown. The objective of this trial was to evaluate whether a recommendation of non-supervised physical activity improved recovery after breast cancer surgery.

METHODS

This parallel, unblinded, multicentre interventional trial randomized women in whom breast cancer surgery was planned. The intervention consisted of an individual recommendation of added aerobic physical activity (30 min/day), before and 4 weeks after surgery. The control group did not receive any advice regarding physical activity. The primary outcome was patient-reported physical recovery at 4 weeks after surgery. Secondary outcomes included mental recovery, complications, reoperations, and readmissions.

RESULTS

Between November 2016 and December 2018, 400 patients were randomized, 200 to each group. Some 370 participants (180 intervention, 190 control) remained at 4 weeks, and 368 at 90 days. There was no significant difference in favour of the intervention for the primary outcome physical recovery (risk ratio (RR) 1.03, 95 per cent c.i. 0.95 to 1.13). There was also no difference for mental recovery (RR 1.05, 0.93 to 1.17) nor in mean Comprehensive Complication Index score (4.2 (range 0-57.5) versus 4.7 (0-58.3)) between the intervention and control groups.

CONCLUSION

An intervention with recommended non-supervised physical activity before and after breast cancer surgery did not improve recovery at 4 weeks after surgery. Registration number: NCT02560662 (http://www.clinicaltrials.gov).

摘要

背景

术前体力活动对原发性乳腺癌手术后的恢复和并发症的影响尚不清楚。本试验旨在评估对非监督体力活动的建议是否能改善乳腺癌手术后的恢复。

方法

这是一项平行、非盲、多中心的干预性试验,纳入了计划接受乳腺癌手术的女性患者。干预措施包括在手术前和手术后 4 周内,为每位患者推荐额外的有氧运动(每天 30 分钟)。对照组未收到任何关于体力活动的建议。主要结局是术后 4 周时患者报告的体力恢复情况。次要结局包括心理恢复、并发症、再次手术和再次入院。

结果

2016 年 11 月至 2018 年 12 月期间,共随机分配了 400 名患者,每组 200 名。术后 4 周时,370 名(180 名干预组,190 名对照组)参与者和 90 天时的 368 名参与者仍在接受随访。干预组在主要结局体力恢复方面没有明显优于对照组(风险比(RR)1.03,95%置信区间(CI)0.95 至 1.13)。在心理恢复(RR 1.05,93%CI 0.93 至 1.17)和综合并发症指数评分均值(4.2(0-57.5)与 4.7(0-58.3))方面,干预组与对照组之间也没有差异。

结论

乳腺癌手术后推荐的非监督体力活动干预措施并未改善术后 4 周时的恢复。注册号:NCT02560662(http://www.clinicaltrials.gov)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5a0/10364922/e772e284cfe3/znaa007f1.jpg

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