PROFITH (PROmoting FITness and Health through Physical Activity) Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, 18007 Granada, Spain.
Department of Physiology, Faculty of Medicine, EFFECTS-262 Research Group, University of Granada, 18016 Granada, Spain.
Nutrients. 2022 Nov 3;14(21):4647. doi: 10.3390/nu14214647.
ONCOFIT is a randomized clinical trial with a two-arm parallel design aimed at determining the influence of a multidisciplinary Prehabilitation and Postoperative Program (PPP) on post-surgery complications in patients undergoing resection of colon cancer. This intervention will include supervised physical exercise, dietary behavior change, and psychological support comparing its influence to the standard care. Primary and secondary endpoints will be assessed at baseline, at preoperative conditions, at the end of the PPP intervention (after 12 weeks) and 1-year post-surgery, and will include: post-surgery complications (primary endpoint); prolonged hospital length of stay; readmissions and emergency department call within 1-year after surgery; functional capacity; patient reported outcome measures targeted; anthropometry and body composition; clinical/tumor parameters; physical activity levels and sedentariness; dietary habits; other unhealthy habits; sleep quality; and fecal microbiota diversity and composition. Considering the feasibility of the present intervention in a real-life scenario, ONCOFIT will contribute to the standardization of a cost-effective strategy for preventing and improving health-related consequences in patients undergoing resection of colon cancer with an important clinical and economic impact, not only in the scientific community, but also in clinical practice.
ONCOFIT 是一项随机临床试验，采用两臂平行设计，旨在确定多学科围手术期预康复和康复方案（PPP）对接受结肠癌切除术患者术后并发症的影响。该干预措施将包括监督下的体育锻炼、饮食行为改变和心理支持，将其影响与标准护理进行比较。主要和次要终点将在基线、术前条件、PPP 干预结束时（12 周后）和术后 1 年进行评估，包括：术后并发症（主要终点）；延长住院时间；术后 1 年内再次入院和急诊就诊；功能能力；以患者为中心的报告结果测量；人体测量和身体成分；临床/肿瘤参数；身体活动水平和久坐行为；饮食习惯；其他不健康习惯；睡眠质量；以及粪便微生物多样性和组成。考虑到本研究中干预措施在现实环境中的可行性，ONCOFIT 将有助于为预防和改善接受结肠癌切除术患者的健康相关后果制定一种具有成本效益的策略，这不仅对科学界，而且对临床实践也具有重要的临床和经济影响。
