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胃肠道癌手术后个体化、有针对性的步数干预:Fit-4-Home 随机临床试验。

Individualised, targeted step count intervention following gastrointestinal cancer surgery: The Fit-4-Home randomised clinical trial.

机构信息

Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital (RPAH), Sydney, Australia.

Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, Australia.

出版信息

ANZ J Surg. 2022 Apr;92(4):703-711. doi: 10.1111/ans.17212. Epub 2021 Sep 22.

DOI:10.1111/ans.17212
PMID:34553480
Abstract

BACKGROUND

To determine the effectiveness of an individualised, daily targeted step count intervention and usual care compared with usual care alone on improving surgical and patient reported outcomes.

METHODS

The Fit-4-Home trial was a pragmatic, randomised controlled trial conducted from April 2019 to February 2021. Patients undergoing elective surgery for liver, stomach or pancreatic cancer in two Australian hospitals were recruited. Participants were randomly allocated to receive an individualised, targeted step count intervention and usual care (intervention) or usual care alone (control). A wearable activity tracker was provided to the intervention group to monitor their daily step count target. Primary outcome was the length of stay in the gastrointestinal ward. Secondary outcomes included postoperative complication rates, discharge destination, quality of life, physical activity, pain, fatigue, distress and hospital re-admission within 30 days. Outcome measures were compared between groups using non-parametric statistics.

RESULTS

Of the 96 patients recruited, 47 were randomised to the intervention group and 49 were randomised to the control group. The median (interquartile) length of stay in the ward was 7 days (5.0-13.0) in the intervention group and 7 days (5.0- 12.0) in the control group (p = 0.330). Fatigue scores were worse in the intervention group when compared to control (p = 0.018). No other differences between groups were observed.

CONCLUSIONS

An individualised, daily targeted step count intervention and usual care did not confer additional benefits in reducing the length of stay in the ward compared to usual care alone for patients undergoing gastrointestinal cancer surgery.

TRIAL REGISTRATION

Registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12619000194167).

摘要

背景

为了确定与单独接受常规护理相比,针对个人的、每日目标步数干预措施与常规护理相结合在改善手术和患者报告的结果方面的效果。

方法

Fit-4-Home 试验是一项从 2019 年 4 月至 2021 年 2 月进行的实用、随机对照试验。在澳大利亚的两家医院招募了接受择期手术治疗肝、胃或胰腺癌症的患者。参与者被随机分配接受个体化、针对性的步数干预和常规护理(干预组)或单独接受常规护理(对照组)。为干预组提供了一个可穿戴活动追踪器来监测他们的每日目标步数。主要结局是胃肠道病房的住院时间。次要结局包括术后并发症发生率、出院去向、生活质量、身体活动、疼痛、疲劳、痛苦和 30 天内再次入院。使用非参数统计比较组间的结果测量。

结果

在招募的 96 名患者中,47 名被随机分配到干预组,49 名被随机分配到对照组。干预组病房的中位(四分位间距)住院时间为 7 天(5.0-13.0),对照组为 7 天(5.0-12.0)(p=0.330)。与对照组相比,干预组的疲劳评分更差(p=0.018)。未观察到组间的其他差异。

结论

与单独接受常规护理相比,针对个人的、每日目标步数干预和常规护理并不能为接受胃肠道癌症手术的患者减少病房住院时间带来额外益处。

试验注册

在澳大利亚和新西兰临床试验注册中心注册(ACTRN12619000194167)。

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