What side effects are associated with this type of intervention?

Common treatments for oropharyngeal dysphagia, such as Expiratory Muscle Strength Training (EMST), aim to improve swallowing safety and reduce aspiration. While these exercise-based approaches can enhance muscle strength and function, they may not always lead to significant improvements in post-swallow residues. Side effects are generally minimal but can include muscle fatigue and discomfort from the exercises. In some cases, patients may experience temporary soreness or strain in the targeted muscles. Overall, these treatments are considered safe and well-tolerated, with the primary goal of enhancing swallowing function and reducing the risk of aspiration.

What prior FDA approvals exist?

There are no specific FDA-approved drugs mentioned in the provided context for the treatment of Oropharyngeal Dysphagia that directly align with Expiratory Muscle Strength Training (EMST). EMST itself is a non-pharmacologic intervention aimed at strengthening expiratory muscles to improve cough function and reduce aspiration. This method has shown promising results in improving swallowing safety and lung clearance in elderly patients with swallowing disorders. For pharmacologic treatments, the context does not provide specific FDA-approved drugs for Oropharyngeal Dysphagia, suggesting that current management may rely more on therapeutic exercises and non-drug interventions.

What other types of research exist?

Promising novel alternatives to Expiratory Muscle Strength Training (EMST) for Oropharyngeal Dysphagia patients include: 1) Systematic voice training combined with swallowing function exercises, which has shown to reduce the incidence of swallowing dysfunction, malnutrition, and aspiration pneumonia. 2) Tongue strengthening exercises, particularly for head and neck cancer patients, which can improve tongue strength and swallowing function. 3) Noninvasive ventilatory support and mechanical insufflation-exsufflation, which can aid in respiratory muscle dysfunction and improve overall swallowing safety.

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Behavioural Intervention

Expiratory Muscle Training for Swallowing Disorders

N/A

Waitlist Available

Led By Jessica Davenport, MHSc, S-LP

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Identified by their speech-language pathologist as at risk for laryngeal penetration/aspiration when drinking thin liquids

A Penetration Aspiration Scale score of 3+ on at least one thin liquid bolus during pre-test videofluoroscopy, as rated live at the time of test by the speech-language pathologist conducting the videofluoroscopy

Must not have

At time of consent: General medical exclusions: Any history of hernia, pneumothorax, perforated tympanic membrane, recent surgery, untreated gastroesophageal reflux disease or untreated hypertension

At time of consent: Cognitively and/or physically unable to perform study tasks, despite support

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using a handheld breathing device can help elderly residents with swallowing problems at Sunnybrook Veterans Centre. The goal is to see if it improves their ability to cough and swallow safely, reducing the risk of lung infections.

Who is the study for?

This trial is for English-speaking veterans with swallowing difficulties living in long-term care at Sunnybrook Veterans Centre. They must be able to perform study tasks or have a support team, and get medical clearance. Those at risk of food/liquid entering their lungs and with certain scores on a swallowing test can join. People with conditions like hernias, lung issues, recent surgeries, untreated reflux or hypertension cannot participate.

What is being tested?

The study tests if slow-stream expiratory muscle strength training (EMST) over eight weeks helps elderly residents improve cough function and reduce aspiration risks during swallowing. It involves using a hand-held device to strengthen breathing muscles, measured by cough under spirometry and swallowing safety under videofluoroscopy.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from using the resistance device or fatigue due to the exercises involved in EMST. Increased intrathoracic pressure could potentially exacerbate underlying health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My speech therapist says I might choke on thin liquids.

Select...

I have trouble swallowing thin liquids, confirmed by a special X-ray test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I don't have a history of hernia, lung collapse, ear drum issues, recent surgery, untreated stomach acid problems, or high blood pressure.

Select...

I am unable to perform study tasks, even with help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment baseline, 10 weeks after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-treatment baseline, 10 weeks after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment baseline, 10 weeks after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Penetration Aspiration Scale (PAS)

Voluntary Cough Volume Acceleration

Secondary study objectives

Dysphagia Handicap Index Emotional Subscale (DysHI-E)

International Dysphagia Diet Standardization Initiative Functional Diet Scale (IDDSI-FDS)

Other study objectives

Incidence of Respiratory Tract Infections Requiring Antibiotics

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Slow-Stream Expiratory Muscle Strength TrainingExperimental Treatment1 Intervention

The therapy protocol consists of 12 sets of five breaths through the EMST150 device per week, in sessions of three or four sets (15 or 20 breaths). A typical schedule might be one 15 breath session four days per week, or one 20 breath session three days per week.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Oropharyngeal dysphagia treatments often focus on improving the strength and coordination of the muscles involved in swallowing. Expiratory Muscle Strength Training (EMST) is a key treatment that strengthens the expiratory muscles, enhancing cough function and reducing the risk of aspiration by improving airway clearance. This is crucial for patients with oropharyngeal dysphagia as it helps prevent food and liquid from entering the lungs, thereby reducing the risk of pneumonia and other respiratory complications. Other treatments may include postural techniques and swallowing exercises, which aim to optimize the mechanics of swallowing and ensure safer and more efficient passage of food and liquids.

Possible Rehabilitation Procedures to Treat Sarcopenic Dysphagia.Expiratory muscle strength training improves swallowing and respiratory outcomes in people with dysphagia: A systematic review.Effect of simultaneous application of postural techniques and expiratory muscle strength training on the enhancement of the swallowing function of patients with dysphagia caused by parkinson's disease.