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一项针对青少年和青年癌症患者的监督式运动干预措施-FiGHTING F!T:一项随机对照试验的研究方案。

A supervised exercise intervention during cancer treatment for adolescents and young adults-FiGHTING F!T: study protocol of a randomised controlled trial.

机构信息

School of Human Sciences (Exercise and Sport Science), University of Western Australia, Perth, Western Australia, Australia.

Western Australian Youth Cancer Service, Perth, Western Australia, Australia.

出版信息

Trials. 2021 Oct 3;22(1):676. doi: 10.1186/s13063-021-05616-8.

Abstract

BACKGROUND

High-quality evidence supports the integration of exercise to mitigate treatment-related side effects in a wide range of paediatric and adult cancer cohorts. However, the implementation of exercise in adolescent and young adult (AYA) cancer patients is yet to be explored in depth. FiGHTINGF!T is a randomised controlled cross over trial designed to determine if a supervised, structured, and progressive exercise programme can reduce the decline in physical fitness (V0) associated with cancer treatment in AYAs from diagnosis.

METHODS/DESIGN: A total of 40 AYAs recently diagnosed and due to commence systemic treatment (± 2 weeks) for a primary haematological malignancy or solid tumour will be recruited and randomised to either an immediate exercise intervention or usual care (delayed exercise) for 10 weeks. This randomised controlled crossover trial will see both groups engage in a supervised exercise intervention from either diagnosis (baseline assessment) for 10 weeks (0-10 weeks) or following an interim assessment to 20 weeks (10-20 weeks). The bi-weekly tailored exercise programme will combine aerobic and resistance exercises and be supervised by an Accredited Exercise Physiologist. Participants will complete a range of assessments at 0, 10, and 20 weeks including cardiopulmonary exercise tests, 1 repetition maximum strength measures, physical functioning, and self-reported quality of life measurements. Patient-reported treatment-related toxicities will be recorded on a weekly basis.

DISCUSSION

The FiGHTINGF!T trial will provide insight into the potential benefits of a supervised exercise programme in AYAs undergoing cancer treatment. This trial will contribute to the evidence supporting the necessary integration of exercise during cancer treatment, specifically in the under-reported AYA cohort.

TRIAL REGISTRATION

This trial was registered retrospectively with the Australia New Zealand Clinical Trial registry ( ACTRN12620000663954 ). Registered on 10 June 2020.

摘要

背景

高质量证据支持将运动融入到广泛的儿科和成人癌症队列中,以减轻治疗相关的副作用。然而,在青少年和年轻成人(AYA)癌症患者中实施运动的情况尚未深入探讨。FiGHTINGF!T 是一项随机对照交叉试验,旨在确定一个监督、结构化和渐进的运动方案是否可以减少与癌症治疗相关的 AYA 体能下降(V0)。

方法/设计:共招募 40 名最近被诊断出患有原发性血液恶性肿瘤或实体瘤且即将开始全身治疗(±2 周)的 AYA,并随机分为立即进行运动干预组或常规护理(延迟运动)组,进行 10 周的治疗。这项随机对照交叉试验将使两组在诊断后(基线评估)进行 10 周(0-10 周)或在中期评估后进行 20 周(10-20 周)的监督性运动干预。两周一次的定制运动方案将结合有氧运动和阻力运动,并由认证的运动生理学家进行监督。参与者将在 0、10 和 20 周时完成一系列评估,包括心肺运动测试、1 次重复最大力量测量、身体功能和自我报告的生活质量测量。每周记录患者报告的治疗相关毒性。

讨论

FiGHTINGF!T 试验将提供有关监督性运动方案在接受癌症治疗的 AYA 中的潜在益处的见解。这项试验将为支持在癌症治疗中进行必要的运动提供证据,特别是在报告不足的 AYA 队列中。

试验注册

该试验是在澳大利亚和新西兰临床试验注册中心(ACTRN12620000663954)进行的回顾性注册。注册于 2020 年 6 月 10 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/516b/8489079/b537cbddb32a/13063_2021_5616_Fig1_HTML.jpg

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