Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000923460
Ethics application status
Approved
Date submitted
17/07/2025
Date registered
25/08/2025
Date last updated
25/08/2025
Date data sharing statement initially provided
25/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early dysphagia rehab in Critical Care: a randomised controlled trial on the effect of Expiratory Muscle Strength Training on swallowing, voice and cough outcomes
Scientific title
Early dysphagia rehab in Critical Care: a randomised controlled trial on the effect of Expiratory Muscle Strength Training on swallowing, voice and cough outcomes
Secondary ID [1] 314765 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EMST RCT in critical care
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficulty in swallowing 338132 0
Impaired vocal function 338133 0
cough 338134 0
Condition category
Condition code
Physical Medicine / Rehabilitation 334418 334418 0 0
Speech therapy
Oral and Gastrointestinal 334782 334782 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Expiratory muscle strength training (EMST) + usual dysphagia care

EMST is a treatment designed to strengthen the expiratory (breathing out) muscles. It involves blowing into a small device against a pressure load. The device is called the EMST150 and the participant will need to breathe into it for 5 sets of 5 breaths, 5 days per week, for 5 weeks. The pressure load is increased as the participant gets stronger, similar to increasing the amount of weight you might lift at the gym as you get stronger. Each session will take approximately 20 minutes. Treatment sessions will be conducted face-to-face under the guidance of the study speech pathologist.
Intervention code [1] 331460 0
Rehabilitation
Comparator / control treatment
Usual dysphagia care only

Usual dysphagia care is the accepted standard of care treatment conducted in line with evidence-based practice and outlined by the profession's national peak body, Speech Pathology Australia. This typically involves diet and fluid modification, compensatory techniques and potentially some volitional active swallow strengthening exercises. If volitional swallowing strengthening exercises are implemented, this typically takes 10-20 minutes daily for the period that the individual is dysphagic. Treatment will be delivered by the Study Speech Pathologist during the participant's admission.
Control group
Active

Outcomes
Primary outcome [1] 342116 0
Change in swallow function
Timepoint [1] 342116 0
Baseline, 2-weeks, 5-weeks, post-commencement of treatment and on completion of treatment (if different to 5-weeks) Primary endpoint is on completion of treatment
Primary outcome [2] 342420 0
Change in respiratory function
Timepoint [2] 342420 0
Baseline, 2-weeks, 5-weeks, post-commencement of treatment and on completion of treatment (if different to 5-weeks) Primary endpoint is on completion of treatment
Primary outcome [3] 342421 0
Change in cough function
Timepoint [3] 342421 0
Baseline, 2-weeks, 5-weeks, post-commencement of treatment and on completion of treatment (if different to 5-weeks) Primary endpoint is on completion of treatment
Secondary outcome [1] 449600 0
Change in self-rated scores of swallowing function
Timepoint [1] 449600 0
Baseline, 2-weeks, 5-weeks, post-commencement of treatment and on completion of treatment (if different to 5-weeks)
Secondary outcome [2] 450734 0
Change in self-rated scores of communicative ability
Timepoint [2] 450734 0
Baseline, 2-weeks, 5-weeks, post-commencement of treatment and on completion of treatment (if different to 5-weeks)
Secondary outcome [3] 451072 0
Change in voice function
Timepoint [3] 451072 0
Baseline, 2-weeks, 5-weeks, post-commencement of treatment and on completion of treatment (if different to 5-weeks)

Eligibility
Key inclusion criteria
1. Individuals aged 18 years or over admitted to ICUs at study sites being treated with the intent to survive.
2. Patients must have received >7 days of prolonged invasive ventilation.
3. Tracheostomy and non-invasive ventilation may have formed part of treatment.
4. Dysphagia as defined by Clinical Swallowing Examination (CSE) with abnormal rating on the FOIS outcome measure scales (detailed further in methods).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients whose swallow function is not suitable to be assessed due to poor prognosis for survival as determined by managing intensivist.
2. Patients whose swallow function is not suitable to be assessed post-extubation for surgical reasons e.g. gastrointestinal surgery.
3. Patients unable to participate in prescribed therapy regime due to inadequate cognitive capacity, recent H&N surgery, end stage respiratory disease, uncontrolled hypertension.
4. Previous history of dysphagia or dysphonia. Patients who are not able to receive endoscopic assessments or participate in EMST.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study randomisation has been generated using an online random numbers generator with allocation for participants across each site involved
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/01/2025
Date of last participant enrolment
Anticipated
1/09/2027
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28195 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 28196 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 44407 0
2139 - Concord
Recruitment postcode(s) [2] 44408 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 27192 0
New Zealand
State/province [1] 27192 0
Auckland, Waikato, Capitol Coast

Funding & Sponsors
Funding source category [1] 319317 0
Charities/Societies/Foundations
Name [1] 319317 0
Auckland Medical Research Foundation
Country [1] 319317 0
New Zealand
Funding source category [2] 319470 0
Charities/Societies/Foundations
Name [2] 319470 0
New Zealand Greenlane Research and Education Fund
Country [2] 319470 0
New Zealand
Funding source category [3] 319474 0
Charities/Societies/Foundations
Name [3] 319474 0
New Zealand Paykel Trust Project and Equipment Grant
Country [3] 319474 0
New Zealand
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 321794 0
University
Name [1] 321794 0
Auckland University
Address [1] 321794 0
Country [1] 321794 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317897 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 317897 0
Ethics committee country [1] 317897 0
Australia
Date submitted for ethics approval [1] 317897 0
04/07/2025
Approval date [1] 317897 0
Ethics approval number [1] 317897 0
Ethics committee name [2] 318044 0
Southern Health and Disability Ethics Committee
Ethics committee address [2] 318044 0
Ethics committee country [2] 318044 0
New Zealand
Date submitted for ethics approval [2] 318044 0
05/12/2023
Approval date [2] 318044 0
18/12/2023
Ethics approval number [2] 318044 0
2023 EXP 19166

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142498 0
A/Prof Anna Miles
Address 142498 0
Rm 507-2066, Building 507, 28 Park Avenue (Grafton Campus), School of Psychology, Faculty of Science, The University of Auckland 1142
Country 142498 0
New Zealand
Phone 142498 0
+64 9 9238177
Fax 142498 0
Email 142498 0
[email protected]
Contact person for public queries
Name 142499 0
Dr Nicola Clayton
Address 142499 0
Speech Pathology Department, Concord Repatriation General Hospital, Hospital Rd Concord NSW 2139
Country 142499 0
Australia
Phone 142499 0
+61 2 97675133
Fax 142499 0
Email 142499 0
[email protected]
Contact person for scientific queries
Name 142500 0
A/Prof Anna Miles
Address 142500 0
Rm 507-2066, Building 507, 28 Park Avenue (Grafton Campus), School of Psychology, Faculty of Science, The University of Auckland 1142
Country 142500 0
New Zealand
Phone 142500 0
+64 9 9238177
Fax 142500 0
Email 142500 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.