Efficacy of the SUPERvised PREhabilitation with Personalised, Aerobic training, Respiratory muscle training and EDucation (SUPER-PREPARED) multi-model in patients with abdominal surgery: protocol for a single-blind, randomised controlled trial

针对腹部手术患者的监督式术前康复(包括个性化有氧训练、呼吸肌训练和教育)多模式(SUPER-PREPARED)的疗效:一项单盲随机对照试验方案

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Abstract

INTRODUCTION: Globally, millions of abdominal surgeries are performed annually, placing a substantial burden on public health systems worldwide. Postoperative pulmonary complications (PPCs) are common negative consequences after major abdominal surgery that can worsen recovery outcomes. Although the effect of prehabilitation has been frequently investigated in this population, the feasibility and efficacy of delivering a supervised, intensive exercise programme within a limited preoperative period remain underexplored.This randomised controlled trial (RCT) aims to evaluate the effectiveness of the SUPERvised PREhabilitation with Personalised, Aerobic training, Respiratory muscle training and patient EDucation (SUPER-PREPARED) multi-model to reduce the incidence of PPCs among the population undergoing abdominal surgery. METHODS AND ANALYSIS: The SUPER-PREPARED trial will be a single-centre, prospective, two-arm RCT. A total of 120 participants will be recruited and randomly allocated to either the SUPER-PREPARED group or the usual care group. The primary outcome is the incidence of PPCs, assessed at specific time points (1 day before discharge and 1 month, 6 months and 1 year after surgery). The secondary outcomes include patient-centred measures (functional capacity, quality of life), clinical measures (respiratory muscle function, pulmonary function) and postoperative recovery metrics (postoperative intestinal ventilation timing, length of intensive care unit (ICU) stay, length of postoperative hospital stay, postoperative hospitalisation expenses and readmission rate). The detailed criteria defining PPCs and the schedule of the study are displayed in tables. Data analysis will be independently conducted by two experienced clinicians via the per-protocol analysis. ETHICS AND DISSEMINATION: This study will be conducted in strict accordance with the Declaration of Helsinki (2024). The protocol was approved by the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (2024 nianshen No. 2049). The final results will be disseminated by peer-reviewed journals and presentations at academic conferences. TRIAL REGISTRATION NUMBER: ChiCTR2500102615.

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