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

Not Applicable

Withdrawn

• Conditions: Dysphagia, Oropharyngeal; Dysphagia; Dysphagia, Progressive; Aging; Aspiration Pneumonia; Cough

• Registration Number: NCT04064333
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-8-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Fluent in the English language<br><br> - Identified by their speech-language pathologist as at risk for laryngeal<br> penetration/aspiration when drinking thin liquids<br><br> - A Penetration Aspiration Scale score of 3+ on at least one thin liquid bolus during<br> pre-test videofluoroscopy, as rated live at the time of test by the speech-language<br> pathologist conducting the videofluoroscopy.<br><br> - Cognitively and physically able to perform study tasks (spirometry, EMST). If<br> assistance and/or cuing is required, the participant must have a support team who is<br> agreeable to providing this for the duration of the study at time of consent.<br> Support teams may consist of any combination of family, friends, private companions,<br> and VC staff.<br><br> - Medical clearance by the participant's most responsible physician (MRP)<br><br>Exclusion Criteria:<br><br>At time of consent<br><br> - General medical exclusions: Any history of hernia, pneumothorax, perforated tympanic<br> membrane, recent surgery, untreated gastroesophageal reflux disease or untreated<br> hypertension.<br><br> - Other medical conditions where increased intrathoracic pressure would be<br> contraindicated, on an individual basis, as per participant's MRP<br><br> - Cognitively and/or physically unable to perform study tasks, despite support<br><br> - Participants who do not consent to videofluoroscopy or for whom videofluoroscopy is<br> contraindicated<br><br>After time of consent<br><br> - Participants who score PAS < 3 on pre-test videofluoroscopy<br><br> - Inability to complete pre-post testing for at least one primary outcome<br><br> - Inability to complete minimum 50 breaths of the weekly protocol, and minimum 400<br> total breaths through the device over the 8 week program

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Voluntary Cough Volume Acceleration;Penetration Aspiration Scale (PAS)

Secondary Outcome Measures

Name	Time	Method
Dysphagia Handicap Index Emotional Subscale (DysHI-E);International Dysphagia Diet Standardization Initiative Functional Diet Scale (IDDSI-FDS)