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Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care

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ClinicalTrials.gov Identifier: NCT04064333
Recruitment Status : Not yet recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jessica Davenport, Sunnybrook Health Sciences Centre

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Dysphagia, Oropharyngeal Dysphagia Dysphagia, Progressive Aging Aspiration Pneumonia Cough Device: Slow-Stream Expiratory Muscle Strength Training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Slow-Stream Expiratory Muscle Strength Training
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.
Device: Slow-Stream 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.
Other Names:
  • EMST150
  • Respiratory Muscle Strength Training
  • Expiratory Muscle Strength Training




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. Dysphagia Handicap Index Emotional Subscale (DysHI-E) [ Time Frame: Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention ]
    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.

  2. International Dysphagia Diet Standardization Initiative Functional Diet Scale (IDDSI-FDS) [ Time Frame: Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention ]
    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.


Other Outcome Measures:
  1. Incidence of Respiratory Tract Infections Requiring Antibiotics [ Time Frame: 3 months post-intervention ]
    Incidence of respiratory tract infections requiring antibiotics over the three months following intervention, for comparison with broader institutional data.



Information from the National Library of Medicine

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Ages Eligible for Study:   85 Years to 110 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064333


Contacts
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Contact: Jessica Davenport, MHSc, S-LP 416-480-6100 ext 5829 jessica.davenport@sunnybrook.ca
Contact: Jennifer Wong, MHSc, S-LP 416-480-6100 ext 83704 jenni.wong@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre - Veterans Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Jessica Davenport, MHSc, S-LP    416-480-6100 ext 5829    jessica.davenport@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Study Director: Lisa DiProspero, MRT BSc MSc Director, Practice-Based Research and Innovation
Principal Investigator: Jessica Davenport, MHSc, S-LP Speech-Language Pathologist, Sunnybrook

Additional Information:
Publications:

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Responsible Party: Jessica Davenport, Speech-Language Pathologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04064333     History of Changes
Other Study ID Numbers: Sunnybrook_Women'
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jessica Davenport, Sunnybrook Health Sciences Centre:
Expiratory Muscle Strength Training
Respiratory Muscle Strength Training
EMST
RMST
Videofluoroscopy
Aspiration Pneumonia
Rehabilitation
Dysphagia
Cough
Geriatric
Aging
Older Adults
Additional relevant MeSH terms:
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Deglutition Disorders
Pneumonia
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases