Amsterdam UMC, Location Vrije Universiteit Amsterdam, Rehabilitation Medicine, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Amsterdam Movement Sciences, Ageing & Vitality, Amsterdam, The Netherlands.
Trials. 2023 Nov 27;24(1):757. doi: 10.1186/s13063-023-07705-2.
Improving physical activity, especially in combination with optimizing protein intake, after surgery has a potential positive effect on recovery of physical functioning in patients after gastrointestinal and lung cancer surgery. The aim of this randomized controlled trial is to evaluate the efficacy of a blended intervention to improve physical activity and protein intake after hospital discharge on recovery of physical functioning in these patients.
In this multicenter single-blinded randomized controlled trial, 161 adult patients scheduled for elective gastrointestinal or lung cancer surgery will be randomly assigned to the intervention or control group. The purpose of the Optimal Physical Recovery After Hospitalization (OPRAH) intervention is to encourage self-management of patients in their functional recovery, by using a smartphone application and corresponding accelerometer in combination with coaching by a physiotherapist and dietician during three months after hospital discharge. Study outcomes will be measured prior to surgery (baseline) and one, four, eight, and twelve weeks and six months after hospital discharge. The primary outcome is recovery in physical functioning six months after surgery, and the most important secondary outcome is physical activity. Other outcomes include lean body mass, muscle mass, protein intake, symptoms, physical performance, self-reported limitations in activities and participation, self-efficacy, hospital readmissions and adverse events.
The results of this study will demonstrate whether a blended intervention to support patients increasing their level of physical activity and protein intake after hospital discharge improves recovery in physical functioning in patients after gastrointestinal and lung cancer surgery.
The trial has been registered at the International Clinical Trials Registry Platform at 14-10-2021 with registration number NL9793. Trial registration data are presented in Table 1.
术后增加身体活动量，尤其是结合优化蛋白质摄入量，可能对胃肠道癌和肺癌手术后患者身体功能的恢复有积极影响。本随机对照试验的目的是评估混合干预措施在改善出院后身体活动和蛋白质摄入量对这些患者身体功能恢复的效果。
在这项多中心单盲随机对照试验中，将 161 名择期行胃肠道或肺癌手术的成年患者随机分配至干预组或对照组。Optimal Physical Recovery After Hospitalization（OPRAH）干预的目的是通过在出院后三个月使用智能手机应用程序和相应的加速度计并结合物理治疗师和营养师的指导，鼓励患者自我管理其功能恢复。研究结果将在术前（基线）以及出院后 1、4、8 和 12 周和 6 个月进行测量。主要结局是术后 6 个月的身体功能恢复情况，最重要的次要结局是身体活动量。其他结局包括去脂体重、肌肉量、蛋白质摄入量、症状、身体表现、活动和参与受限的自我报告、自我效能、医院再入院和不良事件。
本研究的结果将表明，出院后支持患者增加身体活动量和蛋白质摄入量的混合干预措施是否能改善胃肠道癌和肺癌手术后患者的身体功能恢复情况。
该试验于 2021 年 10 月 14 日在国际临床试验注册平台上注册，注册编号为 NL9793。试验注册数据如表 1 所示。
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