NCT04064333

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 85 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphagia, Oropharyngeal
• Dysphagia
• Dysphagia, Progressive
• Aging
• Aspiration Pneumonia
• Cough

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2019-08-21
• Last updated: 2024-08-23

Locations

1 site across 1 country: Canada