Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04064333
Status:
WITHDRAWN
Last Update Posted:
2022-08-15
First Post:
2019-08-16
Brief Title:
Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI employment change
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 foodliquid 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 foodliquid 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 setsweek has had promising results in improving cough function and reducing laryngeal penetrationaspiration PA 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 individuals 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 residents 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 setsweek 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 PA 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
Expiratory muscle strength training EMST applied within a four-week intensive program 25 setsweek has had promising results in improving cough function and reducing laryngeal penetrationaspiration PA 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 individuals 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 residents 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 setsweek 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 PA 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None