上消化道和直肠肿瘤患者新辅助治疗期间的预康复-研究方案。

IF 2.6 Q2 SPORT SCIENCES Frontiers in Sports and Active Living Pub Date : 2025-02-03 eCollection Date: 2024-01-01 DOI:10.3389/fspor.2024.1495398
Irina Chmelova, Dalibor Pastucha, Tomas Hudecek, Zdenek Guran, Sona Ciecotkova, Lubomír Martínek, Jana Zubikova, Alena Matlova, Jakub Dolezel, Dana Salounova, Jakub Chmelo
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引用次数: 0

摘要

目的:康复的概念被定义为旨在增强患者在即将到来的生理应激源之前的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。该研究的目的是验证或反驳两组诊断患者在新辅助化疗(放射)治疗期间预康复计划的可行性,这是在预定的外科手术之前规定的。这是一项单组研究设计,所有入组患者均接受干预。方法:本研究是一项以在家进行体能训练为形式的康复计划的介入可行性研究。训练包括渐进式步行和选定肌肉群的力量练习。数据将通过遥测技术监测,也可通过与参与者的电话联系进行监测。主要结果包括:观察期间在俄斯特拉发大学医院接受新辅助治疗的所有患者中有兴趣参加研究的患者的百分比,完成术前康复计划的患者的百分比以及个体患者的依从性。次要结果包括通过心肺运动测试获得的体能参数,通过测力机测量的握力,身体成分的变化,EORTC QLQ-C30生活质量问卷,以及关于运动计划主观感知的问卷。主要和次要结局将在研究组(两个诊断组)之间进行比较。该研究已在ClinicalTrials.gov注册,ID: NCT05646043。结论:本研究结果可为未来更大规模、多中心、对照研究奠定基础。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Prehabilitation during neoadjuvant therapy in patients with cancer of the upper gastrointestinal tract and rectum-the study protocol.

Aims: 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.

Methods: 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.

Conclusion: The results of this study can serve as a foundation for larger, multicentre, controlled studies in the future.

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CiteScore
2.60
自引率
7.40%
发文量
459
审稿时长
15 weeks
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