Aging Clinical Trial
Official title:
Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 85 Years to 110 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: At time of consent - General medical exclusions: Any history of hernia, pneumothorax, perforated tympanic membrane, recent surgery, untreated gastroesophageal reflux disease or untreated hypertension. - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre - Veterans Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of Respiratory Tract Infections Requiring Antibiotics | Incidence of respiratory tract infections requiring antibiotics over the three months following intervention, for comparison with broader institutional data. | 3 months post-intervention | |
Primary | 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 | |
Primary | 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 | Dysphagia Handicap Index Emotional Subscale (DysHI-E) | Change in swallowing-related quality of life. The DysHI-E consists of seven questions answered using a 3-point scale of Never, Sometimes, and Always, and a 7-point severity scale ranging from 1-normal to 7-severe problem (Silbergleit et al., 2012). This will be converted into a visual analogue scale and responses will be measured in centimeters from left to right, with the far left end being Never or 0.00 cm, and the far right end being Always or 30.00 cm. | Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention | |
Secondary | International Dysphagia Diet Standardization Initiative Functional Diet Scale (IDDSI-FDS) | Change in the level of diet texture restriction secondary to dysphagia. The IDDSI-FDS measures the number of diet texture levels allowed from the International Dysphagia Diet Standardization Initiative Framework. | Pre-treatment baseline, 10 weeks after baseline, 3 months post-intervention |
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