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

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Slow-Stream Expiratory Muscle Strength Training for swallowing disorders?

Research shows that expiratory muscle strength training can improve swallowing function in people with swallowing difficulties, such as those who have had a stroke. Studies found that patients who received this training had better swallowing outcomes compared to those who did not. ^{1 2 3 4 5}

Is expiratory muscle strength training safe for humans?

Expiratory muscle strength training has been studied in people with conditions like stroke and Parkinson's disease, and no significant safety issues have been reported in these studies. ^{1 2 6 7 8}

How does Slow-Stream Expiratory Muscle Strength Training differ from other treatments for swallowing disorders?

Slow-Stream Expiratory Muscle Strength Training is unique because it specifically targets the muscles involved in swallowing by increasing their strength and activation, which can improve swallowing function. Unlike other treatments, it focuses on enhancing the force generation of the submental muscles, which are crucial for normal swallowing, and has shown significant improvements in swallowing outcomes in patients with dysphagia (difficulty swallowing) after a stroke. ^{1 2 3 6 9}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Expiratory muscle strength training improves swallowing and respiratory outcomes in people with dysphagia: A systematic review. [2019]

2. Japan pubmed.ncbi.nlm.nih.gov

Effects of expiratory muscle strength training on swallowing function in acute stroke patients with dysphagia. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of Swallowing and Cough Functions Following Stroke: An Expiratory Muscle Strength Training Trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of Expiratory Muscle Strength Training on Swallowing and Cough Functions in Patients With Neurological Diseases: A Meta-analysis. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Expiratory Muscle Strength Training on Videofluoroscopic Measures of Swallowing: A Systematic Review. [2021]

6. England pubmed.ncbi.nlm.nih.gov

High elevation training mask as a respiratory muscle strength training tool for dysphagia. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Detraining outcomes with expiratory muscle strength training in Parkinson disease. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Safety and performance of oropharyngeal muscle strength training in the treatment of post-stroke dysphagia during oral feeding: protocol for a systematic review and meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Surface electromyographic activity of the submental muscles during swallow and expiratory pressure threshold training tasks. [2018]