跳至主要内容
临床试验/CTRI/2026/01/101318
CTRI/2026/01/101318
尚未招募
2/3 期

Effect of Expiratory Muscle Strength Training on Dysphagia and Aspiration Prevention in Post Glossectomy Patients A Randomized Controlled Trial

未提供1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2026年1月27日最近更新:

概览

阶段
2/3 期
状态
尚未招募
入组人数
98
试验地点
1
主要终点
Change in MEP (cm H20) from baseline to 4weeks

概览

简要总结

Global incidence trends in Head and Neck cancer worldwide. The overall incidence of HNC continues to rise, with a predict 30 percent increase annually by 2030. The majority of new cases of HNSCC annually are related to smoking and alcohol consumption with five year survival rate only approximately 50 percent . Surgery is an effective treatment for these patients. However dysphagia and aspiration occur frequently post operatively with Tongue cancer having majority of burden. The degree of dysphagia depends on the amount of normal tissue resected and they have a poor quality of life and develop anxiety and depression when they aspirate and become dependent on Tracheostomy Tube and Ryles tube.

We routinely provide standard exercise therapy post operatively like chin tuck or  head turns and supraglottic swallow. But despite notable refinements in swallow therapy over the last three decades attempts to reverse aspiration with swallowing therapy are often disappointing. Therefore new emerging devices like EMST means Expiratory muscle strength training device  are inexpensive and provide device driven exercise therapy. During EMST our task is to strengthen recruited muscles over time. EMST acts on one of two mechanisms one by Strengthening subglottic expiratory pressure generating forces, translating to a stronger cough to clear aspirate from the lower airway or  Improving airway closure for swallowing by exercise of swallowing related muscles such as those in the submental suprahyoid region.

Rationale of EMST device in HNC patients

In several populations to date EMST has been shown to increase expiratory pressure generation by 30 percent to 150percent with an average of 50 percent in a 4 weeks period of time. EMST is accordingly gaining popularity among various populations with swallowing disorders but to our knowledge the  results of EMST have not evaluated in Tongue patients. Thus the purpose of this study will be to examine the therapeutic potential of EMST among Post Glossectomy associated aspiration and dysphagia. We hypothesize that expiratory force generating capacity indicated by Maximum expiratory pressures and swallowing safety by Penetration or Aspiration measured by Functional endoscopic evaluation of swallowing  would improve after 4 weeks of EMST.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Primary respectable tumor of Tongue.
  • Patient undergoing Compartmental, Subtotal, Near Total Glossectomies.

排除标准

  • Chronic radiation exposed patients of Tongue carcinoma.
  • Recurrent/ Relapsed and metastatic patients/ Unresectable cases.
  • Neurological disorders affecting swallowing, Prior swallowing impaired or Severe dysphagia patients.
  • Severe Cardiopulmonary conditions impacting expiratory efforts.

结局指标

主要结局

Change in MEP (cm H20) from baseline to 4weeks

时间窗: 2years

次要结局

  • 1. Time to removal of Ryles Tube (days post-surgery)(2. Aspiration events in control vs treatment groups)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

DR Manish Verma

AIIMS , New Delhi

研究点 (1)

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