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基于全喉切除术患者的个体化指导自助式运动方案的有效性:一项多中心随机对照试验的结果。

Effectiveness of a guided self-help exercise program tailored to patients treated with total laryngectomy: Results of a multi-center randomized controlled trial.

机构信息

Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands; Department of Behavioural and Movement Sciences, Section Clinical Psychology, Vrije Universiteit, Amsterdam Public Health, van der Boechorststraat 7, 1081 BT Amsterdam, the Netherlands.

Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands.

出版信息

Oral Oncol. 2020 Apr;103:104586. doi: 10.1016/j.oraloncology.2020.104586. Epub 2020 Feb 8.

DOI:10.1016/j.oraloncology.2020.104586
PMID:32045734
Abstract

OBJECTIVE

To investigate the effectiveness of a guided self-help exercise program on swallowing, speech, and shoulder problems in patients treated with total laryngectomy (TL).

MATERIALS AND METHODS

This randomized controlled trial included patients treated with TL in the last 5 years. Patients were randomized into the intervention group (self-help exercise program with flexibility, range-of-motion and lymphedema exercises and self-care education program) or control group (self-care education program). Both groups completed measurements before and 3 and 6-months after randomization. The primary outcome was swallowing problems (SWAL-QOL). Secondary outcomes were speech problems (SHI), shoulder problems (SDQ), self-management (patient activation: PAM) and health-related quality of life (HRQOL: EORTC QLQ-C30/H&N35). Adherence was defined as moderate-high in case a patient exercised >1 per day. Linear mixed model analyses were conducted to investigate the effectiveness of the intervention and to investigate whether neck dissection, treatment indication (primary/salvage TL), time since treatment, severity of problems, and preferred format (online/booklet) moderated the effectiveness.

RESULTS

Moderate-high adherence to the exercise program was 59%. The intervention group (n = 46) reported less swallowing and communication problems over time compared to the control group (n = 46) (p-value = 0.013 and 0.004). No difference was found on speech, shoulder problems, patient activation and HRQOL. Time since treatment moderated the effectiveness on speech problems (p-value = 0.025): patients within 6 months after surgery benefitted most from the intervention. Being treated with a neck dissection, treatment indication, severity of problems and format did not moderate the effectiveness.

CONCLUSION

The guided self-help exercise program improves swallowing and communication.

TRIAL REGISTRATION

NTR5255.

摘要

目的

研究指导自助锻炼计划对全喉切除术(TL)治疗患者吞咽、言语和肩部问题的效果。

材料与方法

本随机对照试验纳入了过去 5 年内接受 TL 治疗的患者。患者被随机分为干预组(灵活性、活动度和淋巴水肿锻炼以及自我护理教育计划自助锻炼计划)或对照组(自我护理教育计划)。两组均在随机分组前和 3 个月、6 个月后进行测量。主要结局是吞咽问题(SWAL-QOL)。次要结局为言语问题(SHI)、肩部问题(SDQ)、自我管理(患者激活:PAM)和健康相关生活质量(EORTC QLQ-C30/H&N35)。如果患者每天锻炼 >1 次,则定义为中高度依从。线性混合模型分析用于研究干预的效果,并研究颈部清扫术、治疗指征(原发性/挽救性 TL)、治疗后时间、问题严重程度和首选格式(在线/手册)是否调节了效果。

结果

锻炼计划的中高度依从率为 59%。与对照组(n=46)相比,干预组(n=46)在随访期间报告的吞咽和交流问题较少(p 值=0.013 和 0.004)。言语、肩部问题、患者激活和 HRQOL 无差异。治疗后时间调节了言语问题的效果(p 值=0.025):手术后 6 个月内的患者从干预中获益最大。颈部清扫术、治疗指征、问题严重程度和格式不会调节效果。

结论

指导自助锻炼计划可改善吞咽和交流。

试验注册

NTR5255。

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