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一项针对接受重大癌症手术患者的术前运动计划的可行性和可接受性:一项试点随机对照试验的结果

Feasibility and acceptability of a preoperative exercise program for patients undergoing major cancer surgery: results from a pilot randomized controlled trial.

作者信息

Steffens Daniel, Young Jane, Beckenkamp Paula R, Ratcliffe James, Rubie Freya, Ansari Nabila, Pillinger Neil, Koh Cherry, Munoz Phillip A, Solomon Michael

机构信息

Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital (RPAH), Missenden Road, Camperdown, New South Wales, 2050, Australia.

Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Building 89, Leval 9, Missenden Road, Camperdown, New South Wales, 2006, Australia.

出版信息

Pilot Feasibility Stud. 2021 Jan 13;7(1):27. doi: 10.1186/s40814-021-00765-8.

Abstract

OBJECTIVE

To establish the feasibility and acceptability of a preoperative exercise program, and to obtain pilot data on the likely difference in key surgical outcomes to inform the sample size calculation for a full-scale trial.

DESIGN

Pilot randomized controlled trial.

SETTING

Royal Prince Alfred Hospital, Sydney, Australia.

SUBJECTS

We included patients undergoing elective pelvic exenteration or cytoreductive surgery aged 18 to 80 years, who presented to the participating gastrointestinal surgeon at least 2 weeks prior to surgery. Patients presenting cognitive impairment, co-morbidity preventing participation in exercise, inadequate English language, currently participating in an exercise program or unable to attend the exercise program sessions were excluded.

METHODS

Participants were randomized to a 2-6 weeks preoperative, face-to-face, individualised exercise program or to usual care. Feasibility was assessed with consent rates to the study, and for the intervention group, retention and adherence rates to the preoperative exercise program. Acceptability of the exercise program was assessed with a semi-structured questionnaire exploring the advice received and the amount, duration and intensity of the exercise program. In addition, postoperative complication rates (Clavien-Dindo), length of hospital stay and self-reported measures of health-related quality of life (SF-36v2) were collected at baseline, day before surgery and in-hospital up to discharge from hospital.

RESULTS

Of 122 patients screened, 26 (21%) were eligible and 22 (85%) accepted to participate in the trial and were randomized to the intervention (11; 50%) or control group (11; 50%). The median age of the include participants was 63 years. Adherence to the preoperative exercise sessions was 92.7%, with all participants either satisfied (33%) or extremely satisfied (67%) with the overall design of the preoperative exercise program. No significant differences in outcomes were found between groups.

CONCLUSIONS

The results of our pilot trial demonstrate that a preoperative exercise program is feasible and acceptable to patients undergoing major abdominal cancer surgery. There is an urgent need for a definite trial investigating the effectiveness of a preoperative exercise program on postoperative outcomes in patients undergoing major abdominal cancer surgery. This could potentially reduce postoperative complication rates, length of hospital stay and subsequently overall health care costs.

TRIAL REGISTRATION

ACTRN12617001129370. Registered on August 1, 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373396&showOriginal=true&isReview=true.

摘要

目的

确定术前运动计划的可行性和可接受性,并获取关键手术结局可能差异的初步数据,为全面试验的样本量计算提供依据。

设计

初步随机对照试验。

地点

澳大利亚悉尼皇家阿尔弗雷德王子医院。

研究对象

我们纳入了年龄在18至80岁之间、计划接受择期盆腔脏器清除术或肿瘤细胞减灭术的患者,这些患者在手术前至少2周就诊于参与研究的胃肠外科医生处。存在认知障碍、合并症导致无法参与运动、英语水平不足、目前正在参加运动计划或无法参加运动计划课程的患者被排除。

方法

参与者被随机分为接受为期2 - 6周的术前面对面个性化运动计划组或常规护理组。通过研究的同意率评估可行性,对于干预组,评估术前运动计划的保留率和依从率。通过一份半结构化问卷评估运动计划的可接受性,该问卷探讨了收到的建议以及运动计划的量、持续时间和强度。此外,在基线、手术前一天和住院直至出院时收集术后并发症发生率(Clavien-Dindo分级)、住院时间以及自我报告的健康相关生活质量指标(SF-36v2)。

结果

在122名筛查的患者中,26名(21%)符合条件,22名(85%)同意参与试验并被随机分为干预组(11名;50%)或对照组(11名;50%)。纳入参与者的中位年龄为63岁。术前运动课程的依从率为92.7%,所有参与者对术前运动计划的总体设计要么满意(33%)要么极其满意(67%)。两组之间在结局方面未发现显著差异。

结论

我们初步试验的结果表明,术前运动计划对于接受大型腹部癌症手术的患者是可行且可接受的。迫切需要进行一项确定性试验,以研究术前运动计划对接受大型腹部癌症手术患者术后结局的有效性。这有可能降低术后并发症发生率、住院时间,进而降低总体医疗费用。

试验注册

ACTRN12617001129370。于2017年8月1日注册,https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373396&showOriginal=true&isReview=true。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24f4/7805142/f8e1c854f762/40814_2021_765_Fig1_HTML.jpg

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