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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 belowSelect...
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
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.
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.
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.
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,489 Total Patients Enrolled
Jessica Davenport, MHSc, S-LPPrincipal InvestigatorSpeech-Language Pathologist, Sunnybrook
Lisa DiProspero, MRT BSc MScStudy DirectorDirector, Practice-Based Research and Innovation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Before agreeing to join the study, participants must have a videofluoroscopy test that shows a PAS score of at least 3.My speech therapist says I might choke on thin liquids.I can do study tasks or have someone to help me.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.I have trouble swallowing thin liquids, confirmed by a special X-ray test.I am unable to perform study tasks, even with help.
Research Study Groups:
This trial has the following groups:- Group 1: Slow-Stream Expiratory Muscle Strength Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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