Steffens Daniel, Young Jane, Beckenkamp Paula R, Ratcliffe James, Rubie Freya, Ansari Nabila, Pillinger Neil, Solomon Michael
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Building 89, Level 9, Missenden Road, Camperdown, Sydney, NSW, 2050, Australia.
Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.
Trials. 2018 Feb 17;19(1):112. doi: 10.1186/s13063-018-2481-2.
There is a need for evidence of the effectiveness of pre-operative exercise for patients undergoing major cancer surgery; however, recruitment to such trials can be challenging. The PrE-operative Physical Activity (PEPA) Trial will establish the feasibility and acceptability of a pre-operative exercise programme aimed to improve patient outcomes after cytoreductive surgery and pelvic exenteration. The secondary aim is to obtain pilot data on the likely difference in key outcomes (post-operative complications, length of hospital stay, post-operative functional capacity and quality of life) to inform the sample size calculation for the substantive randomised clinical trial.
METHODS/DESIGN: Twenty patients undergoing cytoreductive surgery and pelvic exenteration at the Royal Prince Alfred Hospital, Sydney will be recruited and randomly allocated (1:1 ratio) to either 2 to 6 weeks' pre-operative exercise programme (intervention group) or usual care (control group). Those randomised to the intervention group will receive up to six individualised, 1-h physiotherapy sessions (including aerobic and endurance exercises, respiratory muscle exercises, stretching and flexibility exercises), home exercises (instruction and recommendations on how to progress the exercises at home) and encouragement to be more active by using an activity tracker to measure the number of steps walked daily. Patients allocated to the control group will not receive any specific advice about exercise training. Feasibility will be assessed with consent rates to the study, and for the intervention group, retention and adherence rates to the exercise programme. Acceptability of the exercise programme will be assessed with a semi-structured questionnaire. The following measures of the effectiveness of the intervention will be collected at baseline (2 to 6 weeks pre-operative), a week before surgery, during hospital stay and pre hospital discharge: post-operative complication rates (Clavien-Dindo), post-operative functional capacity (Six-minute Walk Test) and quality of life (SF-36v2®) and length of hospital stay. Functional status will be additionally measured using Cardiopulmonary Exercise Testing (CPET), at baseline and within a week before surgery.
The PEPA Trial will provide important information about the feasibility and acceptability of a pre-operative exercise programme for patients undergoing major cancer surgery. Data from the PEPA Trial will be used to inform the design, methodology and to calculate sample size required for a larger, definitive trial.
Australian New Zealand Clinical Trials Registry, ID: ACTRN12617001129370 . Registered on 1 August 2017.
对于接受重大癌症手术的患者，术前运动有效性的证据十分必要；然而，招募患者参与此类试验颇具挑战性。术前身体活动（PEPA）试验将确定一项术前运动计划的可行性和可接受性，该计划旨在改善肿瘤细胞减灭术和盆腔廓清术后的患者预后。次要目的是获取关键结局（术后并发症、住院时间、术后功能能力和生活质量）可能差异的试点数据，为实质性随机临床试验的样本量计算提供依据。
方法/设计：将招募20名在悉尼皇家阿尔弗雷德王子医院接受肿瘤细胞减灭术和盆腔廓清术的患者，并随机分配（1:1比例）至2至6周的术前运动计划（干预组）或常规护理（对照组）。随机分配至干预组的患者将接受多达六次个性化的1小时物理治疗课程（包括有氧运动和耐力运动、呼吸肌锻炼、伸展和柔韧性锻炼）、家庭锻炼（关于如何在家中进行锻炼的指导和建议），并通过使用活动追踪器测量每日步数来鼓励增加活动量。分配至对照组的患者不会收到任何有关运动训练的具体建议。将通过研究的同意率以及干预组对运动计划的保留率和依从率来评估可行性。将使用半结构化问卷评估运动计划的可接受性。将在基线（术前2至6周）、手术前一周、住院期间和出院前收集以下干预效果指标：术后并发症发生率（Clavien-Dindo分级）、术后功能能力（六分钟步行试验）、生活质量（SF-36v2®）和住院时间。将在基线和手术前一周内使用心肺运动试验（CPET）额外测量功能状态。
PEPA试验将提供有关重大癌症手术患者术前运动计划可行性和可接受性的重要信息。PEPA试验的数据将用于为更大规模的确定性试验的设计、方法和样本量计算提供依据。
澳大利亚新西兰临床试验注册中心，编号：ACTRN12617001129370。于2017年8月1日注册。
