研究动态
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头颈癌患者个性化家庭锻炼计划的可行性研究方案和多中心单臂干预试验的初步结果 (OSHO #94)。

Feasibility of individualized home exercise programs for patients with head and neck cancer-study protocol and first results of a multicentre single-arm intervention trial (OSHO #94).

发表日期:2024
作者: Sabine Felser, Julia Rogahn, Änne Glass, Lars Arne Bonke, Daniel Fabian Strüder, Jana Stolle, Susann Schulze, Markus Blaurock, Ursula Kriesen, Christian Junghanss, Christina Grosse-Thie
来源: PHYSICAL THERAPY & REHABILITATION JOURNAL

摘要:

头颈癌 (PwHNC) 患者受益于有针对性的运动干预:缓解症状、补偿功能障碍、改善生活质量 (QoL)。关于 PwHNC 接受物理干预的数据很少。 “OSHO #94”试验调查了 PwHNC 中个性化家庭锻炼对生活质量、身体活动和功能的短期和中期影响。该研究包括可行性阶段(概念验证),以评估验收情况。在此,我们介绍研究方案以及可行性结果。这项前瞻性、多中心、单臂干预研究包括年龄≥18岁的 PwHNC,他们接受术后护理或姑息治疗,并在免疫治疗下获得稳定缓解。该研究于 2021 年 1 月 1 日开始,预计于 2024 年 12 月 31 日完成。PwHNC 接受个性化的家庭锻炼计划,包括动员、协调、力量和伸展练习。在 12 周内,每周至少进行 3 次,每次 15 至 30 分钟,并辅以每周 2 至 3 次、每次 30 分钟的有氧训练(干预)。每周与物理治疗师进行一次电话通话。随后,进行为期 12 周的随访 (FU),无需进行锻炼规范/接触。在干预前后以及 FU 之后测量结果。可行性阶段 (n = 25) 的主要结果是确定干预期间的退出率,如果超过 30% 的 PwHNC 过早退出,则终止终止。 OSHO #94' 试验 (N = 53) 的主要结果是干预前后整体生活质量评分的变化 (EORTC QLQ-C30)。次要结果包括临床和患者报告的测量、训练细节以及功能诊断数据(例如体力活动水平、训练频率、灵活性、跌倒风险和有氧运动表现)。25 PwHNC 被纳入可行性队列。只有 16%(4/25 名患者)没有完成研究。因此,PwHNC 的招募仍在继续。辍学率从 30% (N = 60) 调整至 20%(N = 53,计算样本量 n = 42 PwHNC,20% (n = 11) 为辍学)。PwHNC 的术后护理中的个性化家庭锻炼计划似乎是可行的。因此,现在的目标是评估个性化家庭锻炼的短期和中期效果。版权所有:© 2024 Felser 等人。这是一篇根据知识共享署名许可条款分发的开放获取文章,允许在任何媒体上不受限制地使用、分发和复制,前提是注明原始作者和来源。
Patients with head and neck cancer (PwHNC) benefit from targeted exercise interventions: symptom relief, compensation for dysfunction, improvement in quality of life (QoL). Data on acceptance physical interventions in PwHNC are rare. The 'OSHO #94' trial investigates the short- and medium-term effects of individualized home exercise in PwHNC on QoL, physical activity and functionality. The study includes a feasibility phase (proof of concept) in order to evaluate the acceptance. Here we present the study protocol as well as the feasibility results.This prospective, multicentre, single-arm intervention study includes PwHNC ≥18 years of age in aftercare or palliative care with stable remission under immunotherapy. The study opened in January 01, 2021, with estimated completion by December 31, 2024. The PwHNC receive an individualized home exercise program consisting of mobilization, coordination, strengthening and stretching exercises. This should be carried out at least three times a week over 12 weeks for 15 to 30 minutes, supplemented by aerobic training two to three times a week for 30 minutes (intervention). Once weekly telephone calls with a physiotherapist are performed. Subsequently, there is a 12-week follow-up (FU) without exercise specifications/contact. Outcomes are measured before and after the intervention and following the FU. Primary outcome of the feasibility phase (n = 25) was the determination of the dropout rate during the intervention with a termination cut off if more than 30% PwHNC withdrew premature. The primary outcome of the OSHO #94' trial (N = 53) is the change in global QoL score from pre- to post-intervention (EORTC QLQ-C30). Secondary outcomes include clinical and patient-reported measures, training details as well as functional diagnostic data (e.g. level of physical activity, training frequency, flexibility, fall risk and aerobic performance).25 PwHNC were enrolled onto the feasibility cohort. Only16% (4/25 patients) did not complete the study. Therefore, recruitment of PwHNC was continued. The dropout rate was adjusted from 30% (N = 60) to 20% (N = 53, calculated sample size n = 42 PwHNC and 20% (n = 11) to dropout).Individualized home exercise programs in PwHNC in aftercare seem feasible. Consequently, the aim is now to evaluate the short and medium-term effects of individualized home exercise.Copyright: © 2024 Felser et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.