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临床试验/NCT03620084
NCT03620084Unknown不适用

The Effects of Expiratory Muscle Strength Training (EMST) on Airway Protection and Swallowing in Chronic Dysphagia After Radiation Therapy

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Maximum expiratory pressure

研究概览

简要总结

Radiation therapy for head and neck cancer (HNC) is associated with the development of swallowing difficulties, or dysphagia. Dysphagia has profound negative effects on the health, nutritional status, and quality of life of HNC survivors. It also puts them at risk of developing life-threatening aspiration pneumonia. Radiation-associated dysphagia can be intractable and not responsive to conventional dysphagia therapy. HNC survivors with chronic severe dysphagia may be dependent on long-term tube feeding.

Expiratory Muscle Strength Training (EMST) is a low-cost, device-driven therapy. It has been studied as an approach to simultaneously improve cough and swallowing functions. During EMST, patients forcefully expire into a one-way spring-loaded valve to strengthen expiratory and submental musculature. The EMST-150 device is available for clinical use in Singapore. In other research studies, it has been shown to improve cough and swallowing in several populations of people with chronic dysphagia, most recently in people with chronic radiation-associated dysphagia.

The investigators propose to study the effect of EMST using the EMST-150 device on cough, airway protection, and swallowing functions of HNC survivors with radiation-associated dysphagia.

The investigators will recruit 40 participants to undergo an 8-week EMST programme, with weekly follow-up to calibrate their EMST device. It is hypothesised that EMST will improve participants' respiratory and swallowing functions. Respiratory function improvement will be shown by increased maximum expiratory pressure and improved cough airflow measures. Swallowing function improvement will be evidenced by reduced aspiration or improved ability to clear aspirated material during videofluoroscopic swallow studies. The investigators also hypothesize carryover effects on other aspects of swallowing, such as improved hyoid and laryngeal excursions, and improved laryngeal vestibule closure.

With the results of this study, the investigators aim to develop better evidence-based rehabilitation programmes for HNC survivors, and those living with chronic dysphagia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Maximum expiratory pressure

时间窗: up to 8-week intervention

cm H2O

Change in Penetration Aspiration Scale score

时间窗: At baseline and end of 8-week intervention

An 8-point rating scale of the severity of penetration and aspiration events

次要结局

  • Modified Barium Swallow Impairment Profile(At baseline and end of 8-week intervention)
  • Performance Status Scale-Head and Neck(At baseline and end of 8-week intervention)
  • Functional Oral Intake Scale(At baseline and end of 8-week intervention)
  • MD Anderson Dysphagia Inventory(At baseline and end of 8-week intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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