支持性锻炼方案在加速腹部癌症手术后恢复的研究（PREPARE-ABC）：一项多中心随机对照试验的研究方案。

SupPoRtive Exercise Programmes for Accelerating REcovery after major ABdominal Cancer surgery trial (PREPARE-ABC): Study protocol for a multicentre randomized controlled trial.

出版信息

Colorectal Dis. 2021 Oct;23(10):2750-2760. doi: 10.1111/codi.15805. Epub 2021 Sep 2.

Abstract

BACKGROUND

Exercise programmes can increase cardiopulmonary reserve and functional capacity prior to surgery and can improve clinical, functional and survival outcomes after a colorectal cancer diagnosis. However, the impact of pre- and postoperative exercise on postoperative recovery outcomes and longer-term health-related quality of life are unknown; thus, there is a need for high-quality randomized controlled trials.

METHOD

SupPoRtive Exercise Programmes for Accelerating REcovery after major Abdominal Cancer surgery (PREPARE-ABC) is a three-arm multicentre randomized controlled trial with internal pilot. The primary objective is to assess the effects of pre- and postoperative exercise on surgical outcomes and longer-term health-related quality of life in cancer patients undergoing colorectal resection. The aim of PREPARE-ABC is to randomize 1146 patients at the individual level (1:1:1) to hospital-supervised exercise, home-supported exercise or treatment as usual. The primary outcomes are short-term (30-day) morbidity, assessed using the Clavien-Dindo classification, and longer-term health-related quality of life, assessed using the Medical Outcomes Study Health Questionnaire (36-item Short-Form Survey [SF-36]). Secondary outcomes include cardiopulmonary fitness, physical activity behaviour change, psychological health status and cost-effectiveness. A process evaluation of intervention delivery and usual care also will be undertaken.

DISCUSSION

This is the first UK-based definitive randomized controlled trial to investigate the effects of pre- and postoperative exercise on short-term postoperative health outcomes and longer-term health-related quality of life in colorectal cancer patients. The trial will yield robust clinical and cost-effectiveness data to underpin clinical guidance on how exercise programmes should be implemented in the routine management of patients undergoing major colorectal cancer surgery.

摘要

背景

运动方案可在手术前增加心肺储备和功能能力，并改善结直肠癌诊断后的临床、功能和生存结局。然而，术前和术后运动对术后恢复结局和长期健康相关生活质量的影响尚不清楚；因此，需要高质量的随机对照试验。

方法

支持加速主要腹部癌症手术后恢复的运动方案（PREPARE-ABC）是一项三臂多中心随机对照试验，具有内部试点。主要目的是评估术前和术后运动对接受结直肠切除术的癌症患者手术结局和长期健康相关生活质量的影响。PREPARE-ABC 的目的是将 1146 名患者按个体（1:1:1）随机分为医院监督运动、家庭支持运动或常规治疗。主要结局是短期（30 天）发病率，使用 Clavien-Dindo 分类评估，以及长期健康相关生活质量，使用医疗结局研究健康问卷（36 项简短形式调查 [SF-36]）评估。次要结局包括心肺功能适应性、身体活动行为改变、心理健康状况和成本效益。还将进行干预提供和常规护理的过程评估。