Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000601437p
Ethics application status
Not yet submitted
Date submitted
29/05/2025
Date registered
12/06/2025
Date last updated
12/06/2025
Date data sharing statement initially provided
12/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Expiratory muscle strength training in Parkinson’s disease after Deep Brain Stimulation
Scientific title
Expiratory muscle strength training in Parkinson’s disease after Deep Brain Stimulation
Secondary ID [1] 314560 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 337661 0
Hypokinetic Dysarthria 337662 0
Condition category
Condition code
Neurological 333993 333993 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 334054 334054 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The device that will be used for Expiratory Muscle strength Training (EMST) will be the EMST150 (Aspire Products, Gainesville, FL, USA). During the initial face-to-face session, participants will be instructed in proper technique. To use the device, participants will place their lips tightly around the mouthpiece to form a secure seal. The training level with the EMST150 will be set to approximately 75% of each participant's maximum expiratory pressure (MEP) and will be individually adapted using the EMST150 to determine the optimal resistance level. The MEP is done by taking a deep breath and exhaling out through the device intensively. This process is repeated until there is no air coming out from the device. This is a similar level of exertion as blowing out candles as hard as possible. The resistance in the EMST150 ranges from 30–150H2O and can be adjusted in intervals of 30H2O.
The 4-week training program for the therapy group will be conducted in the participants’ homes following written instructions provided by the research team. This training program has been used elsewhere (Claus et al., 2021). Each at-home training session will involve 25 forceful exhalations using the EMST150 device. Participants will begin each exercise with a deep inhalation, followed by a forceful exhalation lasting a few seconds. After each exhalation, they will rest briefly. The exercise will comprise five exhalations, followed by a rest period of at least 15–30 seconds. This sequence will be repeated until the participants complete a total of 25 exhalations. Training sessions will be scheduled five times a week, and participants will use a paper-based journal to document session completions to ensure compliance with the training protocol. The participants will be instructed to continue day-to-day life as normal.
Intervention code [1] 331181 0
Rehabilitation
Intervention code [2] 331223 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341649 0
Assessment of Intelligibility of Dysarthric Speech
Timepoint [1] 341649 0
Post test after 4 weeks of training
Primary outcome [2] 341650 0
Voice Handicap Index
Timepoint [2] 341650 0
Post test after 4 weeks of training
Secondary outcome [1] 448207 0
Dysphagia
Timepoint [1] 448207 0
Post test after 4 weeks of training

Eligibility
Key inclusion criteria
clinically diagnosed with idiopathic PD;
aged between 50 and 75 years;
undergone bilateral STN-DBS surgery no less than 12 months earlier; independently living within the community, able to speak English and free of any signs of dementia (score of 88 and above on the Addenbrooke's Cognitive Examination).
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are undertaking concurrent weekly speech pathology therapy sessions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model analyses will be used to examine the effect of EMST for the outcome measures derived from the clinical scales and speech measurements. The level of significance for all statistical tests will be set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
6/05/2026
Actual
Date of last data collection
Anticipated
6/06/2026
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319108 0
University
Name [1] 319108 0
Australian Catholic University
Country [1] 319108 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Country
Australia
Secondary sponsor category [1] 321573 0
None
Name [1] 321573 0
Address [1] 321573 0
Country [1] 321573 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317705 0
ACU Human Research Ethics Committee
Ethics committee address [1] 317705 0
Ethics committee country [1] 317705 0
Australia
Date submitted for ethics approval [1] 317705 0
18/06/2025
Approval date [1] 317705 0
Ethics approval number [1] 317705 0

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

Contacts
Principal investigator
Name 141874 0
Dr Zachary Conway
Address 141874 0
Australian Catholic University PO Box 456 Virginia Queensland 4014
Country 141874 0
Australia
Phone 141874 0
+61 7 36237385
Fax 141874 0
Email 141874 0
[email protected]
Contact person for public queries
Name 141875 0
Zachary Conway
Address 141875 0
Australian Catholic University PO Box 456 Virginia Queensland 4014
Country 141875 0
Australia
Phone 141875 0
+61 7 36237385
Fax 141875 0
Email 141875 0
[email protected]
Contact person for scientific queries
Name 141876 0
Zachary Conway
Address 141876 0
Australian Catholic University PO Box 456 Virginia Queensland 4014
Country 141876 0
Australia
Phone 141876 0
+61 7 36237385
Fax 141876 0
Email 141876 0
[email protected]

Data sharing statement
Will the study consider sharing 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.