Dysphagia, OropharyngealNCT04064333
Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
A study testing Slow-Stream Expiratory Muscle Strength Training in people with Dysphagia, Oropharyngeal and Dysphagia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Sunnybrook Veterans Centre (VC) is a long-term care (LTC) facility with many elderly residents living with swallowing disorders who are at high risk of developing pneumonia from aspirating food/liquid into their lungs. Read more about this study
- Who is it for?
- Ages 85 to 110 years
- Conditions the study is for
- Dysphagia, Oropharyngeal, Dysphagia, Dysphagia, Progressive
- What is being tested?
- Slow-Stream Expiratory Muscle Strength Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 85 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Fluent in the English language
- 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.
- Cognitively and physically able to perform study tasks (spirometry, EMST). If assistance and/or cuing is required, the participant must have a support team who is agreeable to providing this for the duration of the study at time of consent. Support teams may consist of any combination of family, friends, private companions, and VC staff.
- Medical clearance by the participant's most responsible physician (MRP)
Who cannot join
- At time of consent
- General medical exclusions: Any history of hernia, pneumothorax, perforated tympanic membrane, recent surgery, untreated gastroesophageal reflux disease or untreated hypertension.
- Other medical conditions where increased intrathoracic pressure would be contraindicated, on an individual basis, as per participant's MRP
- Cognitively and/or physically unable to perform study tasks, despite support
- Participants who do not consent to videofluoroscopy or for whom videofluoroscopy is contraindicated
- After time of consent
Show all 9Show fewer
- Participants who score PAS < 3 on pre-test videofluoroscopy
- Inability to complete pre-post testing for at least one primary outcome
- Inability to complete minimum 50 breaths of the weekly protocol, and minimum 400 total breaths through the device over the 8 week program
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centre - Veterans Centre
Toronto, Ontario, M4N 3M5
About this study
Sunnybrook Veterans Centre (VC) is a long-term care (LTC) facility with many elderly residents living with swallowing disorders who are at high risk of developing pneumonia from aspirating food/liquid into their lungs. Expiratory muscle strength training (EMST) using a hand-held resistance device over a four week intensive program has been shown to have promising results in improving cough function and reducing aspiration during swallowing in older, community-dwelling adults. 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 and lung clearance in elderly VC residents with swallowing disorders. Before and after the eight week therapy program, we will measure participants' cough under spirometry, swallowing under videofluoroscopy, and their swallowing-related quality of life and diet texture modification. A three month follow-up visit will measure swallowing-related quality of life again, as well as record incidence of respiratory tract infections requiring antibiotics in the last three months, to be compared with broader institutional data.
Read the detailed description
This study will take place in Sunnybrook Veterans Centre (VC), a long-term care facility (LTC) with many residents above the age of 85 years living with dysphagia. These residents with dysphagia are at high risk of respiratory tract infections from aspiration of food/liquid particles into the lungs, exacerbated by factors like increased dependence for feeding and oral care, decreased mobility, multiple medical comorbidities, polypharmacy, and increased frailty.
Expiratory muscle strength training (EMST) applied within a four-week intensive program (25 sets/week) has had promising results in improving cough function and reducing laryngeal penetration/aspiration (P/A) during swallowing in community-dwelling adults above the age of 65 years. The EMST150 is a handheld device with adjustable resistance that trains respiratory muscles used in exhalation. One set is defined as five exhales through the device set at a resistance level of 75% of an individual's maximum load, with a one minute break between breaths.
The intensive four week EMST program outlined in previous literature was appropriate for the active, community-dwelling population they were studying. However, it would not be appropriate for most of the residents in the VC due to the extreme age, multiple medical comorbidities, increased frailty, and decreased functional independence in this population. An important aim of this study is to promote success by creating a protocol that fits into the average resident's schedule in a feasible way, but also has a similar number of total breaths through the device, in order to achieve clinical results. Resident perspective was sought from the Residents' Council executive and meeting attendees, and the final protocol was approved in a Residents' Council meeting. Participants would continue doing their usual therapies and activities with the EMST protocol being an add-on to that.
The purpose of this study is to explore whether a modified, slow-stream EMST protocol of 12 sets/week over eight weeks is an effective therapy for improving pulmonary clearance and swallowing safety in LTC residents above the age of 85 years who have dysphagia. Primary outcomes will be assessed through a pre-post analysis of voluntary cough strength measured using spirometry, as well as laryngeal P/A measured under videofluoroscopy. Secondary outcome of swallowing-related quality of life will be measured using Dysphagia Handicap Index - Emotional scale and the International Dysphagia Diet Standardization Initiative Functional Diet Scale pre and post intervention, as well as at a 3 month follow-up. Incidence of respiratory tract infections requiring antibiotics in the three months post-intervention will be measured and compared with broader institutional data.
- Conditions
- Dysphagia, Oropharyngeal, Dysphagia, Dysphagia, Progressive, Aging, Aspiration Pneumonia, Cough
- Being tested
- Slow-Stream Expiratory Muscle Strength Training
- Keywords
- EMST, RMST, Expiratory Muscle Strength Training, Respiratory Muscle Strength Training, Videofluoroscopy, Aspiration Pneumonia, Rehabilitation, Dysphagia, Cough, Geriatric, Aging, Older Adults
- Medical subject headings
- Deglutition Disorders, Pneumonia, Aspiration, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-Stream Expiratory Muscle Strength TrainingDevice
Also called EMST150, Respiratory Muscle Strength Training, Expiratory Muscle Strength Training
All participants will receive an initial visit for training on the therapy protocol, use of a weekly therapy log to track breaths, and use and maintenance of the EMST device. This will constitute the first EMST session and will be included in the therapy log as Week 1, Day 1. Each participant will have a minimum of seven weekly check-in visits from the research assistant and/or a member of the research team, where the EMST150 resistance will be recorded and adjusted to maintain training at 75% of their maximum load, as measured using the EMST150 device instruction manual. During these check-in visits, participants will provide their completed weekly therapy log and receive a new log.
| Study group | Role | What they receive |
|---|---|---|
| Slow-Stream Expiratory Muscle Strength Training | Experimental | 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. Receives: Device: Slow-Stream Expiratory Muscle Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary Cough Volume Acceleration
Change in maximum voluntary cough strength pre and post intervention as measured through airflow analysis of digital cough waveform.
The digital waveform will provide measures of inspiratory phase duration (seconds), compression phase duration (seconds), expiratory rise time (seconds), and expiratory peak flow (Litres/second), and cough volume acceleration (Litres/second squared) will be calculated as expiratory peak flow/expiratory phase rise time, as in Pitts et al., 2019, to represent cough strength.
The protocol will consist of three voluntary coughs into a spirometer using a nose-clip, with a brief rest of 30-60 seconds between attempts. The best effort will be used to generate a digital cough waveform to be analyzed separately by two trained raters consisting of members of the research team or research assistant. Any disagreements between raters will be resolved through consensus with a third rater.
Measured: Pre-treatment baseline, 10 weeks after baseline
Penetration Aspiration Scale (PAS)
Change in frequency of laryngeal penetration (PAS scores >2) and aspiration (PAS scores >5) on swallows of thin liquid pre and post intervention.
Videofluoroscopy (VFSS) protocol of four 10 mL thin liquid consisting of 20% w/v concentration of barium (Polibar Plus) and water, performed by the speech-language pathologist (SLP). Video processing will include removing audio, splicing the recordings into deidentified bolus-length clips, and randomizing these for rating. These clips will be rated using the Penetration Aspiration Scale by three SLPs who will attend calibration training at the Swallowing Rehabilitation Research Laboratory at Toronto Rehabilitation Institute. Raters will be blinded to participant and time. All raters will overlap on the first 25 clips, from which inter-rater reliability measures will be taken, and with any disagreements being resolved through consensus. The remaining clips will be divided among the three raters.
Measured: Pre-treatment baseline, 10 weeks after baseline
Secondary outcomes (2)
Dysphagia Handicap Index Emotional Subscale (DysHI-E)
Change in swallowing-related quality of life. The DysHI-E consists of seven questions answered using a 3-point scale of Never, Sometimes, and Always, and a 7-point severity scale ranging from 1-normal to 7-severe problem (Silbergleit et al., 2012). This will be converted into a visual analogue scale and responses will be measured in centimeters from left to right, with the far left end being Never or 0.00 cm, and the far right end being Always or 30.00 cm.
Measured: Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention
International Dysphagia Diet Standardization Initiative Functional Diet Scale (IDDSI-FDS)
Change in the level of diet texture restriction secondary to dysphagia. The IDDSI-FDS measures the number of diet texture levels allowed from the International Dysphagia Diet Standardization Initiative Framework.
Measured: Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study startSep 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: PI employment change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Dysphagia, OropharyngealStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will use an exploratory, cross sectional study design for the pre-post analysis of voluntary cough, measured through spirometry, laryngeal penetration/aspiration during swallow with thin liquids, measured under videofluoroscopy, and dysphagia-related quality of life, measured via questionnaire and diet texture modification scale. There is no control group; all participants will receive the same slow-stream expiratory muscle strength training protocol.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Davenport, Sunnybrook Health Sciences Centre
- Investigators
- Lisa DiProspero, MRT BSc MSc, Study director, Director, Practice-Based Research and InnovationJessica Davenport, MHSc, S-LP, Principal investigator, Speech-Language Pathologist, Sunnybrook
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064333
- Sponsor's protocol ID
- Sunnybrook_Women'
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2019
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
PubMed 8721066Bonilha HS, Huda W, Wilmskoetter J, Martin-Harris B, Tipnis SV. Radiation Risks to Adult Patients Undergoing Modified Barium Swallow Studies. Dysphagia. 2019 Dec;34(6):922-929. doi: 10.1007/s00455-019-09993-w. Epub 2019 Mar 4.
PubMed 30830303Kim J, Davenport P, Sapienza C. Effect of expiratory muscle strength training on elderly cough function. Arch Gerontol Geriatr. 2009 May-Jun;48(3):361-6. doi: 10.1016/j.archger.2008.03.006. Epub 2008 May 23.
PubMed 18457885Tada A, Matsumoto H, Soda R, Endo S, Kawai H, Kimura G, Yamashita M, Okada C, Takahashi K. [Effects of pulmonary rehabilitation in patients with pulmonary tuberculosis sequelae]. Nihon Kokyuki Gakkai Zasshi. 2002 Apr;40(4):275-81. Japanese.
PubMed 12096494Park JS, Oh DH, Chang MY. Effect of expiratory muscle strength training on swallowing-related muscle strength in community-dwelling elderly individuals: a randomized controlled trial. Gerodontology. 2017 Mar;34(1):121-128. doi: 10.1111/ger.12234. Epub 2016 May 16.
PubMed 27198586Pitts T, Bolser D, Rosenbek J, Troche M, Okun MS, Sapienza C. Impact of expiratory muscle strength training on voluntary cough and swallow function in Parkinson disease. Chest. 2009 May;135(5):1301-1308. doi: 10.1378/chest.08-1389. Epub 2008 Nov 24.
PubMed 19029430Silbergleit AK, Schultz L, Jacobson BH, Beardsley T, Johnson AF. The Dysphagia handicap index: development and validation. Dysphagia. 2012 Mar;27(1):46-52. doi: 10.1007/s00455-011-9336-2. Epub 2011 Mar 20.
PubMed 21424584Steele CM, Grace-Martin K. Reflections on Clinical and Statistical Use of the Penetration-Aspiration Scale. Dysphagia. 2017 Oct;32(5):601-616. doi: 10.1007/s00455-017-9809-z. Epub 2017 May 22.
PubMed 28534064Stokely SL, Molfenter SM, Steele CM. Effects of barium concentration on oropharyngeal swallow timing measures. Dysphagia. 2014 Feb;29(1):78-82. doi: 10.1007/s00455-013-9485-6. Epub 2013 Sep 18.
PubMed 24045851Troche MS, Okun MS, Rosenbek JC, Musson N, Fernandez HH, Rodriguez R, Romrell J, Pitts T, Wheeler-Hegland KM, Sapienza CM. Aspiration and swallowing in Parkinson disease and rehabilitation with EMST: a randomized trial. Neurology. 2010 Nov 23;75(21):1912-9. doi: 10.1212/WNL.0b013e3181fef115.
PubMed 21098406Weening-Dijksterhuis E, de Greef MH, Scherder EJ, Slaets JP, van der Schans CP. Frail institutionalized older persons: A comprehensive review on physical exercise, physical fitness, activities of daily living, and quality-of-life. Am J Phys Med Rehabil. 2011 Feb;90(2):156-68. doi: 10.1097/PHM.0b013e3181f703ef.
PubMed 20881587Leung G, Katz PR, Karuza J, Arling GW, Chan A, Berall A, Fallah S, Binns MA, Naglie G. Slow Stream Rehabilitation: A New Model of Post-Acute Care. J Am Med Dir Assoc. 2016 Mar 1;17(3):238-43. doi: 10.1016/j.jamda.2015.10.016. Epub 2015 Dec 2.
PubMed 26654839Steele CM, Namasivayam-MacDonald AM, Guida BT, Cichero JA, Duivestein J, Hanson B, Lam P, Riquelme LF. Creation and Initial Validation of the International Dysphagia Diet Standardisation Initiative Functional Diet Scale. Arch Phys Med Rehabil. 2018 May;99(5):934-944. doi: 10.1016/j.apmr.2018.01.012. Epub 2018 Feb 8.
PubMed 29428348
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
- ClinicalTrials.gov ID
- NCT04064333
- Acronym / sponsor ID
- Sunnybrook_Women'
- Conditions
- Dysphagia, Oropharyngeal, Dysphagia, Dysphagia, Progressive, Aging, Aspiration Pneumonia, Cough
- Keywords
- EMST, RMST, Expiratory Muscle Strength Training, Respiratory Muscle Strength Training, Videofluoroscopy, Aspiration Pneumonia, Rehabilitation, Dysphagia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI employment change
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sunnybrook Veterans Centre (VC) is a long-term care (LTC) facility with many elderly residents living with swallowing disorders who are at high risk of developing pneumonia from aspirating food/liquid into their lungs. Expiratory muscle strength training (EMST) using a hand-held resistance device over a four week intensive program has been shown to have promising results in improving cough function and reducing aspiration during swallowing in older, community-dwelling adults. 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 and lung clearance in elderly VC residents with swallowing disorders. Before and after the eight week therapy program, we will measure participants' cough under spirometry, swallowing under videofluoroscopy, and their swallowing-related quality of life and diet texture modification. A three month follow-up visit will measure swallowing-related quality of life again, as well as record incidence of respiratory tract infections requiring antibiotics in the last three months, to be compared with broader institutional data.
Detailed description
This study will take place in Sunnybrook Veterans Centre (VC), a long-term care facility (LTC) with many residents above the age of 85 years living with dysphagia. These residents with dysphagia are at high risk of respiratory tract infections from aspiration of food/liquid particles into the lungs, exacerbated by factors like increased dependence for feeding and oral care, decreased mobility, multiple medical comorbidities, polypharmacy, and increased frailty.
Expiratory muscle strength training (EMST) applied within a four-week intensive program (25 sets/week) has had promising results in improving cough function and reducing laryngeal penetration/aspiration (P/A) during swallowing in community-dwelling adults above the age of 65 years. The EMST150 is a handheld device with adjustable resistance that trains respiratory muscles used in exhalation. One set is defined as five exhales through the device set at a resistance level of 75% of an individual's maximum load, with a one minute break between breaths.
The intensive four week EMST program outlined in previous literature was appropriate for the active, community-dwelling population they were studying. However, it would not be appropriate for most of the residents in the VC due to the extreme age, multiple medical comorbidities, increased frailty, and decreased functional independence in this population. An important aim of this study is to promote success by creating a protocol that fits into the average resident's schedule in a feasible way, but also has a similar number of total breaths through the device, in order to achieve clinical results. Resident perspective was sought from the Residents' Council executive and meeting attendees, and the final protocol was approved in a Residents' Council meeting. Participants would continue doing their usual therapies and activities with the EMST protocol being an add-on to that.
The purpose of this study is to explore whether a modified, slow-stream EMST protocol of 12 sets/week over eight weeks is an effective therapy for improving pulmonary clearance and swallowing safety in LTC residents above the age of 85 years who have dysphagia. Primary outcomes will be assessed through a pre-post analysis of voluntary cough strength measured using spirometry, as well as laryngeal P/A measured under videofluoroscopy. Secondary outcome of swallowing-related quality of life will be measured using Dysphagia Handicap Index - Emotional scale and the International Dysphagia Diet Standardization Initiative Functional Diet Scale pre and post intervention, as well as at a 3 month follow-up. Incidence of respiratory tract infections requiring antibiotics in the three months post-intervention will be measured and compared with broader institutional data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will use an exploratory, cross sectional study design for the pre-post analysis of voluntary cough, measured through spirometry, laryngeal penetration/aspiration during swallow with thin liquids, measured under videofluoroscopy, and dysphagia-related quality of life, measured via questionnaire and diet texture modification scale. There is no control group; all participants will receive the same slow-stream expiratory muscle strength training protocol.
| Arm | Type | Receives |
|---|---|---|
| Slow-Stream Expiratory Muscle Strength Training | Experimental | Device: Slow-Stream Expiratory Muscle Strength TrainingThe 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 may qualify
- Ages
- 85 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Fluent in the English language
- 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.
- Cognitively and physically able to perform study tasks (spirometry, EMST). If assistance and/or cuing is required, the participant must have a support team who is agreeable to providing this for the duration of the study at time of consent. Support teams may consist of any combination of family, friends, private companions, and VC staff.
- Medical clearance by the participant's most responsible physician (MRP)
Key exclusion criteria (9 listed)
- At time of consent
- General medical exclusions: Any history of hernia, pneumothorax, perforated tympanic membrane, recent surgery, untreated gastroesophageal reflux disease or untreated hypertension.
- Other medical conditions where increased intrathoracic pressure would be contraindicated, on an individual basis, as per participant's MRP
- Cognitively and/or physically unable to perform study tasks, despite support
- Participants who do not consent to videofluoroscopy or for whom videofluoroscopy is contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow-Stream Expiratory Muscle Strength TrainingAlso: EMST150, Respiratory Muscle Strength Training, Expiratory Muscle Strength TrainingAll participants will receive an initial visit for training on the therapy protocol, use of a weekly therapy log to track breaths, and use and maintenance of the EMST device. This will constitute the first EMST session and will be included in the therapy log as Week 1, Day 1. Each participant will have a minimum of seven weekly check-in visits from the research assistant and/or a member of the research team, where the EMST150 resistance will be recorded and adjusted to maintain training at 75% of their maximum load, as measured using the EMST150 device instruction manual. During these check-in visits, participants will provide their completed weekly therapy log and receive a new log. | Device | Slow-Stream Expiratory Muscle Strength Training |
Primary outcome
Voluntary Cough Volume Acceleration
Time frame: Pre-treatment baseline, 10 weeks after baseline
Change in maximum voluntary cough strength pre and post intervention as measured through airflow analysis of digital cough waveform. The digital waveform will provide measures of inspiratory phase duration (seconds), compression phase duration (seconds), expiratory rise time (seconds), and expiratory peak flow (Litres/second), and cough volume acceleration (Litres/second squared) will be calculated as expiratory peak flow/expiratory phase rise time, as in Pitts et al., 2019, to represent cough strength. The protocol will consist of three voluntary coughs into a spirometer using a nose-clip, with a brief rest of 30-60 seconds between attempts. The best effort will be used to generate a digital cough waveform to be analyzed separately by two trained raters consisting of members of the research team or research assistant. Any disagreements between raters will be resolved through consensus with a third rater.
Penetration Aspiration Scale (PAS)
Time frame: Pre-treatment baseline, 10 weeks after baseline
Change in frequency of laryngeal penetration (PAS scores >2) and aspiration (PAS scores >5) on swallows of thin liquid pre and post intervention. Videofluoroscopy (VFSS) protocol of four 10 mL thin liquid consisting of 20% w/v concentration of barium (Polibar Plus) and water, performed by the speech-language pathologist (SLP). Video processing will include removing audio, splicing the recordings into deidentified bolus-length clips, and randomizing these for rating. These clips will be rated using the Penetration Aspiration Scale by three SLPs who will attend calibration training at the Swallowing Rehabilitation Research Laboratory at Toronto Rehabilitation Institute. Raters will be blinded to participant and time. All raters will overlap on the first 25 clips, from which inter-rater reliability measures will be taken, and with any disagreements being resolved through consensus. The remaining clips will be divided among the three raters.
2 secondary outcomes
Dysphagia Handicap Index Emotional Subscale (DysHI-E)
Time frame: Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention
International Dysphagia Diet Standardization Initiative Functional Diet Scale (IDDSI-FDS)
Time frame: Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 8721066Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
- Background: PubMed 30830303Bonilha HS, Huda W, Wilmskoetter J, Martin-Harris B, Tipnis SV. Radiation Risks to Adult Patients Undergoing Modified Barium Swallow Studies. Dysphagia. 2019 Dec;34(6):922-929. doi: 10.1007/s00455-019-09993-w. Epub 2019 Mar 4.
- Background: PubMed 18457885Kim J, Davenport P, Sapienza C. Effect of expiratory muscle strength training on elderly cough function. Arch Gerontol Geriatr. 2009 May-Jun;48(3):361-6. doi: 10.1016/j.archger.2008.03.006. Epub 2008 May 23.
- Background: PubMed 12096494Tada A, Matsumoto H, Soda R, Endo S, Kawai H, Kimura G, Yamashita M, Okada C, Takahashi K. [Effects of pulmonary rehabilitation in patients with pulmonary tuberculosis sequelae]. Nihon Kokyuki Gakkai Zasshi. 2002 Apr;40(4):275-81. Japanese.
- Background: PubMed 27198586Park JS, Oh DH, Chang MY. Effect of expiratory muscle strength training on swallowing-related muscle strength in community-dwelling elderly individuals: a randomized controlled trial. Gerodontology. 2017 Mar;34(1):121-128. doi: 10.1111/ger.12234. Epub 2016 May 16.
- Background: PubMed 19029430Pitts T, Bolser D, Rosenbek J, Troche M, Okun MS, Sapienza C. Impact of expiratory muscle strength training on voluntary cough and swallow function in Parkinson disease. Chest. 2009 May;135(5):1301-1308. doi: 10.1378/chest.08-1389. Epub 2008 Nov 24.
- Background: PubMed 21424584Silbergleit AK, Schultz L, Jacobson BH, Beardsley T, Johnson AF. The Dysphagia handicap index: development and validation. Dysphagia. 2012 Mar;27(1):46-52. doi: 10.1007/s00455-011-9336-2. Epub 2011 Mar 20.
- Background: PubMed 28534064Steele CM, Grace-Martin K. Reflections on Clinical and Statistical Use of the Penetration-Aspiration Scale. Dysphagia. 2017 Oct;32(5):601-616. doi: 10.1007/s00455-017-9809-z. Epub 2017 May 22.
- Background: PubMed 24045851Stokely SL, Molfenter SM, Steele CM. Effects of barium concentration on oropharyngeal swallow timing measures. Dysphagia. 2014 Feb;29(1):78-82. doi: 10.1007/s00455-013-9485-6. Epub 2013 Sep 18.
- Background: PubMed 21098406Troche MS, Okun MS, Rosenbek JC, Musson N, Fernandez HH, Rodriguez R, Romrell J, Pitts T, Wheeler-Hegland KM, Sapienza CM. Aspiration and swallowing in Parkinson disease and rehabilitation with EMST: a randomized trial. Neurology. 2010 Nov 23;75(21):1912-9. doi: 10.1212/WNL.0b013e3181fef115.
- Background: PubMed 20881587Weening-Dijksterhuis E, de Greef MH, Scherder EJ, Slaets JP, van der Schans CP. Frail institutionalized older persons: A comprehensive review on physical exercise, physical fitness, activities of daily living, and quality-of-life. Am J Phys Med Rehabil. 2011 Feb;90(2):156-68. doi: 10.1097/PHM.0b013e3181f703ef.
- Background: PubMed 26654839Leung G, Katz PR, Karuza J, Arling GW, Chan A, Berall A, Fallah S, Binns MA, Naglie G. Slow Stream Rehabilitation: A New Model of Post-Acute Care. J Am Med Dir Assoc. 2016 Mar 1;17(3):238-43. doi: 10.1016/j.jamda.2015.10.016. Epub 2015 Dec 2.
- Website of Expiratory Muscle Strength Trainer (EMST150) used in protocolLink provided by the sponsor.
- Website of International Dysphagia Diet Standardization Initiative, basis of Functional Diet ScaleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa DiProspero, MRT BSc MSc study director
Director, Practice-Based Research and Innovation
Jessica Davenport, MHSc, S-LP principal investigator
Speech-Language Pathologist, Sunnybrook
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow-Stream Expiratory Muscle Strength Training in people with Dysphagia, Oropharyngeal and Dysphagia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voluntary Cough Volume Acceleration (time frame: Pre-treatment baseline, 10 weeks after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04064333, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.