Clinical trial NCT04064333: Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
Official title: Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
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
Cough
Geriatric
Aging
Older Adults
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 0
Sex: ALL
Minimum age (years): 85
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Voluntary Cough Volume Acceleration
timeFrame: Pre-treatment baseline, 10 weeks after baseline
measure: Penetration Aspiration Scale (PAS)
timeFrame: Pre-treatment baseline, 10 weeks after baseline
Secondary outcomes:
measure: Dysphagia Handicap Index Emotional Subscale (DysHI-E)
timeFrame: Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention
measure: International Dysphagia Diet Standardization Initiative Functional Diet Scale (IDDSI-FDS)
timeFrame: Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention
Other outcomes:
measure: Incidence of Respiratory Tract Infections Requiring Antibiotics
timeFrame: 3 months post-intervention
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre - Veterans Centre
state: Ontario
Study officials:
affiliation: Director, Practice-Based Research and Innovation
name: Lisa DiProspero, MRT BSc MSc
role: STUDY_DIRECTOR
affiliation: Speech-Language Pathologist, Sunnybrook
name: Jessica Davenport, MHSc, S-LP
role: PRINCIPAL_INVESTIGATOR
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