Chmelova Irina, Pastucha Dalibor, Hudecek Tomas, Guran Zdenek, Ciecotkova Sona, Martínek Lubomír, Zubikova Jana, Matlova Alena, Dolezel Jakub, Salounova Dana, Chmelo Jakub
Department of Rehabilitation and Sports Medicine, University Hospital Ostrava, Ostrava, Czechia.
Department of Rehabilitation and Sports Medicine, Faculty of Medicine, University of Ostrava, Ostrava, Czechia.
Front Sports Act Living. 2025 Feb 3;6:1495398. doi: 10.3389/fspor.2024.1495398. eCollection 2024.
The concept of prehabilitation, defined as interventions aimed at enhancing a patient's functional capacity prior to an impending physiological stressor, may contribute to reduced postoperative morbidity and mortality. The study's goal is to verify or refute the feasibility of a prehabilitation programme for two diagnostic patient groups during neoadjuvant chemo(radio)therapy, which is prescribed before the scheduled surgical procedure. This is a single group study design, with all patients enrolled receiving the intervention.
This is an interventional feasibility study of a prehabilitation programme in the form of physical training conducted at home. The training consists of progressively dosed walking and strength exercises for selected muscle groups. Data will be monitored telemetrically and also through telephone contact with participants. Primary outcomes include: the percentage of patients interested in participating in the study out of all patients indicated for neoadjuvant therapy at University Hospital Ostrava during the observed period, the percentage of patients who complete the prehabilitation programme until the date of surgery and individual patient compliance. Secondary outcomes include physical fitness parameters obtained from cardiopulmonary exercise testing, grip strength measured by a dynamometer, changes in body composition, EORTC QLQ-C30 quality of life questionnaire, and a questionnaire on the subjective perception of the exercise programme. Both primary and secondary outcomes will be compared between study arms (two diagnostic groups). The study is registered at ClinicalTrials.gov, ID: NCT05646043.
The results of this study can serve as a foundation for larger, multicentre, controlled studies in the future.
预康复的概念被定义为在即将面临生理应激源之前旨在提高患者功能能力的干预措施,可能有助于降低术后发病率和死亡率。本研究的目标是验证或反驳针对两个诊断患者组在新辅助化疗(放疗)期间进行预康复计划的可行性,新辅助化疗(放疗)是在预定手术前进行的。这是一项单组研究设计,所有入组患者均接受干预。
这是一项关于以在家中进行体育锻炼形式的预康复计划的介入性可行性研究。训练包括针对选定肌肉群进行逐步增加剂量的步行和力量练习。数据将通过遥测进行监测,也通过与参与者的电话联系进行监测。主要结果包括:在观察期内,俄斯特拉发大学医院所有被指定进行新辅助治疗的患者中对参与研究感兴趣的患者百分比、在手术日期前完成预康复计划的患者百分比以及个体患者的依从性。次要结果包括从心肺运动测试中获得的体能参数、用测力计测量的握力、身体成分的变化、欧洲癌症研究与治疗组织QLQ-C30生活质量问卷以及关于运动计划主观感受的问卷。主要和次要结果都将在研究组(两个诊断组)之间进行比较。该研究已在ClinicalTrials.gov注册,ID:NCT05646043。
本研究结果可为未来更大规模、多中心、对照研究奠定基础。