Effect of Expiratory Muscle Strength Training on Dysphagia and Aspiration Prevention in Post Glossectomy Patients A Randomized Controlled Trial
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
DR Manish Verma
AIIMS , New Delhi