Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Aging
  • Aspiration Pneumonia
  • Cough
  • Dysphagia
  • Dysphagia, Oropharyngeal
  • Dysphagia, Progressive
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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

Participation Requirements

Age
Between 85 years and 110 years
Gender
Both males and females

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,...

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.

Tracking Information

NCT #
NCT04064333
Collaborators
Not Provided
Investigators
Study Director: Lisa DiProspero, MRT BSc MSc Director, Practice-Based Research and Innovation Principal Investigator: Jessica Davenport, MHSc, S-LP Speech-Language Pathologist, Sunnybrook