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

NCT04064333 | Withdrawn

• 1 other identifier: Sunnybrook_Women'
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Voluntary Cough Volume Acceleration

  Change in maximum voluntary cough strength pre and post intervention as measured through airflow analysis of digital cough waveform. The digital waveform will provide measures of inspiratory phase duration (seconds), compression phase duration (seconds), expiratory rise time (seconds), and expiratory peak flow (Litres/second), and cough volume acceleration (Litres/second squared) will be calculated as expiratory peak flow/expiratory phase rise time, as in Pitts et al., 2019, to represent cough strength. The protocol will consist of three voluntary coughs into a spirometer using a nose-clip, with a brief rest of 30-60 seconds between attempts. The best effort will be used to generate a digital cough waveform to be analyzed separately by two trained raters consisting of members of the research team or research assistant. Any disagreements between raters will be resolved through consensus with a third rater.

  Pre-treatment baseline, 10 weeks after baseline

• Penetration Aspiration Scale (PAS)

  Change in frequency of laryngeal penetration (PAS scores \>2) and aspiration (PAS scores \>5) on swallows of thin liquid pre and post intervention. Videofluoroscopy (VFSS) protocol of four 10 mL thin liquid consisting of 20% w/v concentration of barium (Polibar Plus) and water, performed by the speech-language pathologist (SLP). Video processing will include removing audio, splicing the recordings into deidentified bolus-length clips, and randomizing these for rating. These clips will be rated using the Penetration Aspiration Scale by three SLPs who will attend calibration training at the Swallowing Rehabilitation Research Laboratory at Toronto Rehabilitation Institute. Raters will be blinded to participant and time. All raters will overlap on the first 25 clips, from which inter-rater reliability measures will be taken, and with any disagreements being resolved through consensus. The remaining clips will be divided among the three raters.

  Pre-treatment baseline, 10 weeks after baseline

Secondary Outcomes (2)

• Dysphagia Handicap Index Emotional Subscale (DysHI-E)

  Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention

• International Dysphagia Diet Standardization Initiative Functional Diet Scale (IDDSI-FDS)

  Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention

Other Outcomes (1)

• Incidence of Respiratory Tract Infections Requiring Antibiotics

  3 months post-intervention

Study Arms (1)

Slow-Stream Expiratory Muscle Strength Training

EXPERIMENTAL

The therapy protocol consists of 12 sets of five breaths through the EMST150 device per week, in sessions of three or four sets (15 or 20 breaths). A typical schedule might be one 15 breath session four days per week, or one 20 breath session three days per week.

Device: Slow-Stream Expiratory Muscle Strength Training

Interventions

Slow-Stream Expiratory Muscle Strength Training DEVICE

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.

Also known as: EMST150, Respiratory Muscle Strength Training, Expiratory Muscle Strength Training

Slow-Stream Expiratory Muscle Strength Training

Eligibility Criteria

• Age: 85 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• At time of consent
• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre - Veterans Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (13)

• Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.

  PMID: 8721066 BACKGROUND

• Bonilha HS, Huda W, Wilmskoetter J, Martin-Harris B, Tipnis SV. Radiation Risks to Adult Patients Undergoing Modified Barium Swallow Studies. Dysphagia. 2019 Dec;34(6):922-929. doi: 10.1007/s00455-019-09993-w. Epub 2019 Mar 4.

  PMID: 30830303 BACKGROUND

• Kim J, Davenport P, Sapienza C. Effect of expiratory muscle strength training on elderly cough function. Arch Gerontol Geriatr. 2009 May-Jun;48(3):361-6. doi: 10.1016/j.archger.2008.03.006. Epub 2008 May 23.

  PMID: 18457885 BACKGROUND

• Tada A, Matsumoto H, Soda R, Endo S, Kawai H, Kimura G, Yamashita M, Okada C, Takahashi K. [Effects of pulmonary rehabilitation in patients with pulmonary tuberculosis sequelae]. Nihon Kokyuki Gakkai Zasshi. 2002 Apr;40(4):275-81. Japanese.

  PMID: 12096494 BACKGROUND

• Park JS, Oh DH, Chang MY. Effect of expiratory muscle strength training on swallowing-related muscle strength in community-dwelling elderly individuals: a randomized controlled trial. Gerodontology. 2017 Mar;34(1):121-128. doi: 10.1111/ger.12234. Epub 2016 May 16.

  PMID: 27198586 BACKGROUND

• Pitts T, Bolser D, Rosenbek J, Troche M, Okun MS, Sapienza C. Impact of expiratory muscle strength training on voluntary cough and swallow function in Parkinson disease. Chest. 2009 May;135(5):1301-1308. doi: 10.1378/chest.08-1389. Epub 2008 Nov 24.

  PMID: 19029430 BACKGROUND

• Silbergleit AK, Schultz L, Jacobson BH, Beardsley T, Johnson AF. The Dysphagia handicap index: development and validation. Dysphagia. 2012 Mar;27(1):46-52. doi: 10.1007/s00455-011-9336-2. Epub 2011 Mar 20.

  PMID: 21424584 BACKGROUND

• Steele CM, Grace-Martin K. Reflections on Clinical and Statistical Use of the Penetration-Aspiration Scale. Dysphagia. 2017 Oct;32(5):601-616. doi: 10.1007/s00455-017-9809-z. Epub 2017 May 22.

  PMID: 28534064 BACKGROUND

• Stokely SL, Molfenter SM, Steele CM. Effects of barium concentration on oropharyngeal swallow timing measures. Dysphagia. 2014 Feb;29(1):78-82. doi: 10.1007/s00455-013-9485-6. Epub 2013 Sep 18.

  PMID: 24045851 BACKGROUND

• Troche MS, Okun MS, Rosenbek JC, Musson N, Fernandez HH, Rodriguez R, Romrell J, Pitts T, Wheeler-Hegland KM, Sapienza CM. Aspiration and swallowing in Parkinson disease and rehabilitation with EMST: a randomized trial. Neurology. 2010 Nov 23;75(21):1912-9. doi: 10.1212/WNL.0b013e3181fef115.

  PMID: 21098406 BACKGROUND

• Weening-Dijksterhuis E, de Greef MH, Scherder EJ, Slaets JP, van der Schans CP. Frail institutionalized older persons: A comprehensive review on physical exercise, physical fitness, activities of daily living, and quality-of-life. Am J Phys Med Rehabil. 2011 Feb;90(2):156-68. doi: 10.1097/PHM.0b013e3181f703ef.

  PMID: 20881587 BACKGROUND

• Leung G, Katz PR, Karuza J, Arling GW, Chan A, Berall A, Fallah S, Binns MA, Naglie G. Slow Stream Rehabilitation: A New Model of Post-Acute Care. J Am Med Dir Assoc. 2016 Mar 1;17(3):238-43. doi: 10.1016/j.jamda.2015.10.016. Epub 2015 Dec 2.

  PMID: 26654839 BACKGROUND

• Steele CM, Namasivayam-MacDonald AM, Guida BT, Cichero JA, Duivestein J, Hanson B, Lam P, Riquelme LF. Creation and Initial Validation of the International Dysphagia Diet Standardisation Initiative Functional Diet Scale. Arch Phys Med Rehabil. 2018 May;99(5):934-944. doi: 10.1016/j.apmr.2018.01.012. Epub 2018 Feb 8.

  PMID: 29428348 BACKGROUND

Related Links

• Website of Expiratory Muscle Strength Trainer (EMST150) used in protocol
• Website of International Dysphagia Diet Standardization Initiative, basis of Functional Diet Scale

MeSH Terms

Conditions

Deglutition Disorders; Pneumonia, Aspiration; Cough

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa DiProspero, MRT BSc MSc

  Director, Practice-Based Research and Innovation

  STUDY DIRECTOR

• Jessica Davenport, MHSc, S-LP

  Speech-Language Pathologist, Sunnybrook

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Speech-Language Pathologist

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 21, 2019
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)