Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001602213
Ethics application status
Approved
Date submitted
13/09/2018
Date registered
27/09/2018
Date last updated
23/09/2021
Date data sharing statement initially provided
30/08/2019
Date results information initially provided
23/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the use of a non-pharmaceutical method to treat drooling in Parkinson's disease
Scientific title
Exploring the feasibility of using high-intensity expiratory muscle strength training to reduce drooling in people with Parkinson's disease
Secondary ID [1] 296079 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 309650 0
drooling 309651 0
swallowing 309652 0
Condition category
Condition code
Neurological 308450 308450 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 308613 308613 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will explore the feasibility of expiratory muscle strength training (EMST), as a novel, non-invasive treatment approach to reduce drooling in people with PD. We hypothesise that EMST will be feasible and well tolerated in this population and will reduce drooling by strengthening the muscles associated with lip closure and swallowing (Pitts et al., 2009; Troche et al., 2010). This study will collect measures related to feasibility of the intervention, as well as swallowing, drooling, and tongue and lip muscle strength before and after a 6 weeks program of high-intensity EMST training. Supervised training will take place twice a week for six weeks with a speech pathologist at Bentley Hospital. Participants will also be prescribed to complete EMST at home on an additional three days each week (unsupervised). Adherence will be monitored during these unsupervised practice sessions by participants keeping a diary of home practice. During each session, EMST will be conducted using a threshold loading device (EMST 150 device: https://emst150.com/), with the initial training load prescribed at 50% of their baseline maximum expiratory pressure. Participants will perform the EMST in sitting, wearing a nose clip. They will be instructed to breathe at their usual rate and depth. An interval-based training approach will be used to optimise the training load that can be tolerated. Specifically, participants will be asked to breathe with a single forced expiration, followed by a 15 second rest. This is repeated 25 times with a one minute rest every five breaths. During each supervised training session, participants will have their arterial oxygen saturation monitored continuously (via a pulse oximeter) and, at the end of each five breath work interval, they will be asked to rate their perceived exertion (using the 0 to 10 Borg category ratio scale). Training loads will be progressed as quickly as possible with the goal of having the load during the final two-minute work interval perceived as ‘very hard’ (7/10 on the Borg scale) with participants unable to consistently maintain lip closure during their expiratory efforts. The aim of this intervention is to strengthen the muscles required for lip closure and swallowing and thus reduce drooling.
Intervention code [1] 312421 0
Treatment: Other
Comparator / control treatment
No control group. This is a pre-post intervention feasibility study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307435 0
Changes to severity, frequency and impact of drooling will be measured using the Sialorrhea clinical scale for PD. A composite score is obtained with this measure.
Timepoint [1] 307435 0
A double baseline will be carried out and then this measure will also be carried out immediately post therapy.
Primary outcome [2] 307436 0
Feasibility of the study will be determined by measuring recruitment rate, attendance, adherence, attrition, training tolerance, satisfaction and adverse effects. Recruitment rate will be the percentage of participants who agree to participate in the study as a percentage of the number who were approached to participate. Reasons for declining will be recorded. For every participant who agrees to participate, we will record attendance at each assessment and intervention session. Reasons for non-attendance will be recorded. For every participant who agrees to participate, we will record whether all not they complete all tasks requested of them during each assessment and intervention session. They will also keep a diary in which they will record if they completed the home practice at home. Reasons for non-adherence will be noted. We will record the number of participants who complete all aspects of the study as a percentage of the number who consented to participate. Reasons for non-completion will be noted. For every participant, during every supervised training session, the highest load tolerated and overall rating of perceived exertion will be recorded. Each participant who completes the study will be asked to rate the level of satisfaction with the intervention. the rating will be based on a 7-point categorical scale with responses that indicate: completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied, to completely unsatisfied. Reasons for dissatisfaction will be recorded. We will record any adverse effects reported by participants and record details for any participants in which treatment was ceased due to adverse effects.
Timepoint [2] 307436 0
Recruitment rate will be collected during baseline. Attendance, adherence, attrition and adverse effects will be recorded throughout the study. Training tolerance and satisfaction will be determined during the intervention and immediately following.
Secondary outcome [1] 351896 0
Changes to swallowing impairment will be measured withThe Mann Assessment of Swallowing Ability (MASA),
Timepoint [1] 351896 0
The MASA will be carried out twice at baseline and then immediately following treatment.
Secondary outcome [2] 351897 0
Changes to swallowing quality of life will be assessed using the Swallowing Quality of Life measure (SWAL-QOL).
Timepoint [2] 351897 0
The SWAL-QOL will be carried out once prior to intervention and then immediately following intervention.
Secondary outcome [3] 351898 0
Changes to the impact of the swallowing impairment will be assessed using the Functional Oral Intake Scale (FOIS).
Timepoint [3] 351898 0
FOIS will be carried out once prior to intervention and then immediately following intervention.
Secondary outcome [4] 352112 0
Changes to lip strength will be assessed using the Iowa oral performance instrument
Timepoint [4] 352112 0
Lip strength will be measured once at baseline and then immediately following treatment.
Secondary outcome [5] 352113 0
Changes to tongue strength will be measured using the Iowa oral performance instrument
Timepoint [5] 352113 0
Tongue strength will be measured once at baseline and then immediately following treatment.
Secondary outcome [6] 352114 0
Changes to maximal inspiratory pressure as measured by a handheld manometer
Timepoint [6] 352114 0
During baseline maximal inspiratory pressures will be collected during four sessions. Two sessions separated by a least 24 hours in week one of the baseline period and two sessions in week two of the baseline period. During each assessment session, participants will be asked to perform 10 efforts for each measure. The best measure that is within 10% of at least two others will be recorded as the test result. Multiple measures over multiple assessment sessions are needed to account for improvements in these measures known to result from familiarisation and in order to obtain a double baseline. This measure will also be carried out immediately post therapy.
Secondary outcome [7] 352115 0
Changes to maximal expiratory pressure as measured by a handheld manometer
Timepoint [7] 352115 0
During baseline maximal expiratory pressures will be collected during four sessions. Two sessions separated by a least 24 hours in week one of the baseline period and two sessions in week two of the baseline period. During each assessment session, participants will be asked to perform 10 efforts for each measure. The best measure that is within 10% of at least two others will be recorded as the test result. Multiple measures over multiple assessment sessions are needed to account for improvements in these measures known to result from familiarisation and in order to obtain a double baseline. This measure will also be carried out immediately post therapy.
Secondary outcome [8] 352116 0
Changes to peak cough flow as measured by a hand-held flow meter.
Timepoint [8] 352116 0
During baseline peak cough flow will be collected during four sessions. Two sessions separated by a least 24 hours in week one of the baseline period and two sessions in week two of the baseline period. During each assessment session, participants will be asked to perform 10 efforts for each measure. The best measure that is within 10% of at least two others will be recorded as the test result. Multiple measures over multiple assessment sessions are needed to account for improvements in these measures known to result from familiarisation and in order to obtain a double baseline. This measure will also be carried out immediately post therapy.

Eligibility
Key inclusion criteria
A diagnosis of Parkinson's disease and reported difficulties with drooling.
Attends recruitment hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
An inability to understand written or spoken English. Evidence of moderate-severe cognitive impairment. Unable to obtain medical clearance from doctor.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/12/2018
Actual
3/06/2019
Date of last participant enrolment
Anticipated
15/03/2021
Actual
1/02/2021
Date of last data collection
Anticipated
30/04/2021
Actual
2/04/2021
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11864 0
Bentley Health Service - Bentley
Recruitment postcode(s) [1] 24002 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 300671 0
Charities/Societies/Foundations
Name [1] 300671 0
Parkinson's Western Australia
Country [1] 300671 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth
Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 300194 0
Hospital
Name [1] 300194 0
Bentley Health Service
Address [1] 300194 0
18 - 56 Mills Street
Bentley, Western Australia 6102
Country [1] 300194 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301452 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 301452 0
Royal Perth Hospital
Level 5, Colonial House
Wellington Street
PERTH WA 6000
Ethics committee country [1] 301452 0
Australia
Date submitted for ethics approval [1] 301452 0
28/09/2018
Approval date [1] 301452 0
10/12/2018
Ethics approval number [1] 301452 0
RGS00000001335
Ethics committee name [2] 301453 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 301453 0
GPO Box U1987, Perth WA 6845
Ethics committee country [2] 301453 0
Australia
Date submitted for ethics approval [2] 301453 0
31/10/2018
Approval date [2] 301453 0
24/01/2019
Ethics approval number [2] 301453 0
HRE2019-0030

Summary
Brief summary
This study will explore the feasibility of expiratory muscle strength training (EMST), as a novel, non-invasive treatment approach to reduce drooling in people who have Parkinson's disease (PD). The intervention involves breathing into a threshold loading device. The intervention will take place over a 6 week period and will involve both supervised and unsupervised practice. We hypothesise that EMST will be feasible and well tolerated in this population and will reduce drooling in people with PD by strengthening the muscles associated with lip closure and swallowing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87054 0
Dr Naomi Cocks
Address 87054 0
Curtin University
GPO Box U1987, Perth WA 6845
Country 87054 0
Australia
Phone 87054 0
+61 8 9266 2466
Fax 87054 0
Email 87054 0
[email protected]
Contact person for public queries
Name 87055 0
Dr Naomi Cocks
Address 87055 0
Curtin University
GPO Box U1987, Perth WA 6845
Country 87055 0
Australia
Phone 87055 0
+61 8 9266 2466
Fax 87055 0
Email 87055 0
[email protected]
Contact person for scientific queries
Name 87056 0
Dr Naomi Cocks
Address 87056 0
Curtin University
GPO Box U1987, Perth WA 6845
Country 87056 0
Australia
Phone 87056 0
+61 8 9266 2466
Fax 87056 0
Email 87056 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This has not been approved by the relevant ethics committees.


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.