Expiratory Muscle Training for Swallowing Disorders

Overseen By Jessica Davenport, MHSc, S-LP

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Hernia, Pneumothorax, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special breathing exercise, Slow-Stream Expiratory Muscle Strength Training, can improve swallowing safety and lung health in elderly individuals with swallowing disorders. Participants will use a handheld device for breathing exercises over eight weeks to determine if it reduces the risk of food or liquid entering the lungs, which can lead to infections like pneumonia. The trial is designed for English-speaking individuals identified by their speech-language pathologist as having difficulty swallowing thin liquids safely. Participants must be able to perform tasks with or without assistance from a support team. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance the quality of life for those with swallowing disorders.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with your doctor to ensure it is safe to participate.

What prior data suggests that this expiratory muscle training is safe for swallowing disorders?

Studies have shown that Expiratory Muscle Strength Training (EMST) is generally well-tolerated by people with swallowing problems. Research indicates that EMST can improve both coughing and swallowing, potentially lowering the risk of food or liquid entering the lungs and causing pneumonia. Evidence also suggests that EMST strengthens the muscles used for swallowing, enhancing safety.

While some studies did not find clear evidence using certain tests, such as videofluoroscopic tests (a type of X-ray test) for swallowing, the overall findings suggest that EMST is a promising and safe method for improving swallowing and protecting the airway in people with swallowing difficulties. No major reports of negative effects have emerged, making it a potentially safe option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Slow-Stream Expiratory Muscle Strength Training because it offers a unique approach to treating swallowing disorders by directly strengthening the muscles involved in breathing and swallowing. Unlike traditional therapies that might focus on dietary adjustments or swallowing exercises, this method uses a specialized device, the EMST150, to help improve muscle strength through controlled breathing exercises. This non-invasive and straightforward technique could lead to improved swallowing function and quality of life for patients, providing a promising alternative to existing therapies.

What evidence suggests that this slow-stream expiratory muscle strength training is effective for swallowing disorders?

Research has shown that expiratory muscle strength training (EMST) can help older adults improve their swallowing and coughing abilities. One study found that EMST led to better performance in these areas, which is important for preventing food or liquid from entering the lungs. Another study supported that EMST strengthens the cough, helping to clear any food or drink from the airway. These findings suggest that EMST could be a promising way to improve swallowing safety and lung health in elderly people with swallowing problems. Participants in this trial will undergo Slow-Stream Expiratory Muscle Strength Training to evaluate its effectiveness in treating swallowing disorders. ^{1 2 3 6 7}

Who Is on the Research Team?

Jessica Davenport, MHSc, S-LP

Principal Investigator

Speech-Language Pathologist, Sunnybrook

Lisa DiProspero, MRT BSc MSc

Principal Investigator

Director, Practice-Based Research and Innovation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My speech therapist says I might choke on thin liquids.

I can do study tasks or have someone to help me.

Medical clearance by the participant's most responsible physician (MRP)

Exclusion Criteria

Before agreeing to join the study, participants must have a videofluoroscopy test that shows a PAS score of at least 3.

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

You must be able to do at least 50 breaths each week and a total of 400 breaths over the 8-week program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a modified slow-stream EMST protocol of 12 sets/week over eight weeks to improve swallowing safety and lung clearance

8 weeks

Sessions of 3 or 4 sets per week

Follow-up

Participants are monitored for swallowing-related quality of life and incidence of respiratory tract infections

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Slow-Stream Expiratory Muscle Strength Training

Trial Overview 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.

How Is the Trial Designed?

Group I: Slow-Stream Expiratory Muscle Strength Training Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

The Elevation Training Mask 2.0® (ETM) offers adjustable expiratory muscle strength resistance pressures, making it a potential alternative to traditional EMST devices for treating swallowing dysfunction.

Current results indicate that while the ETM provides lower resistance compared to the EMST150, it may still be effective for respiratory muscle strength training, warranting further research on its safety and clinical efficacy in patients with swallowing disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High elevation training mask as a respiratory muscle strength training tool for dysphagia. Shen, SC., Nachalon, Y., Randall, DR., et al.[2019]

A systematic review of 11 studies on expiratory muscle strength training (EMST) for dysphagia showed mixed results regarding its effectiveness on swallowing function, highlighting the need for more standardized measures.

The review noted significant variability in study protocols and patient populations, which complicated the ability to draw clear conclusions about EMST's impact on swallowing as assessed by videofluoroscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Expiratory Muscle Strength Training on Videofluoroscopic Measures of Swallowing: A Systematic Review. Mancopes, R., Smaoui, S., Steele, CM.[2021]

After 3 months of expiratory muscle strength training (EMST), participants with Parkinson's disease showed a 19% improvement in maximum expiratory pressure (MEP), indicating that EMST is effective for enhancing respiratory function.

Following a 3-month detraining period, MEP slightly declined by 2% but remained 17% above baseline levels, suggesting that while some benefits of EMST are retained, maintenance programs may be necessary to sustain improvements in muscle strength and swallowing safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detraining outcomes with expiratory muscle strength training in Parkinson disease. Troche, MS., Rosenbek, JC., Okun, MS., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04064333

Slow-Stream Expiratory Muscle Strength Training for ... The purpose of this study is to explore whether a modified slow-stream protocol of EMST over eight weeks is an effective therapy for improving swallowing safety ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5931232/

Impact of Expiratory Muscle Strength Training on Voluntary ... This study demonstrates clear improvement in cough and swallow, as measured by P/A scores, following EMST training, and it shows it is a viable treatment ...

3. pubs.asha.org pubs.asha.org/doi/10.1044/2019_AJSLP-19-00107

Effects of Expiratory Muscle Strength Training on ... This review failed to find clear evidence regarding the effects of EMST on videofluoroscopic measures of swallowing.

4. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.28552

Expiratory Muscle Strength Training for Therapy of Pharyngeal ... The objective of this study was to verify if 4 week of expiratory muscle strength training can improve pharyngeal dysphagia in the short and long term.

5. cuh.nhs.uk cuh.nhs.uk/patient-information/expiratory-muscle-strength-training-emst/

Expiratory muscle strength training (EMST) | CUH EMST protects your airway during swallowing by focusing on improving: cough strength, which helps clear any food and drink from the airway; the movement and ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/hsr2.70337

Effects of Expiratory Muscle Strength Training on ... There is evidence that EMST causes activation and hypertrophy of the muscles of swallowing, with clinical evidence that it improves swallowing in certain ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29090601/

Expiratory muscle strength training improves swallowing ... Preliminary data suggests expiratory muscle strength training improved airway safety during swallowing in people with dysphagia and increased the strength of ...