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

Not Applicable

• Conditions: Cancer of the Head and Neck
• Interventions: Device: Expiratory Muscle Strength Training (EMST)

• Registration Number: NCT03620084
• Lead Sponsor: Singapore General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-08
• Study Start: 2019-05-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Expiratory Muscle Strength Training (EMST)	Expiratory Muscle Strength Training (EMST)	Participants will be taught how to use the EMST-150 device. The device has a one-way spring-loaded valve calibrated at different resistances that the user can select. The valve will open when expiratory pressure exceeds the threshold set by the user on the device. This threshold is set at 75% of the individual's maximum expiratory pressure for the session.

Primary Outcome Measures

Name	Time	Method
Maximum expiratory pressure	up to 8-week intervention	cm H2O
Change in Penetration Aspiration Scale score	At baseline and end of 8-week intervention	An 8-point rating scale of the severity of penetration and aspiration events

Secondary Outcome Measures

Name	Time	Method
Modified Barium Swallow Impairment Profile	At baseline and end of 8-week intervention	Seventeen components of swallowing are visually rated on video recordings of the modified barium swallow procedure.
Performance Status Scale-Head and Neck	At baseline and end of 8-week intervention	An oral intake scale looking at the normalcy of diet consistencies taken by the patient. The scale ranges from 0 (tube-feeding) to 100 (full diet with no restrictions), in increments of 10.
Functional Oral Intake Scale	At baseline and end of 8-week intervention	A 7-point scale looking at the normalcy of diet consistencies taken by the patient. The lowest score is 1 (No oral intake) and the maximum score is 7 (total oral intake with no restrictions).
MD Anderson Dysphagia Inventory	At baseline and end of 8-week intervention	Self-reported swallowing-related quality of life

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore