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Trial registered on ANZCTR


Registration number
ACTRN12618000090213
Ethics application status
Approved
Date submitted
2/03/2016
Date registered
19/01/2018
Date last updated
23/01/2019
Date data sharing statement initially provided
23/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Expiratory Muscle Strength training (EMST) versus traditional dysphagia rehabilitation for intervention of dysphagia in Parkinson’s disease in the community setting.
Scientific title
Expiratory Muscle Strength training (EMST) versus traditional dysphagia rehabilitation for intervention of dysphagia in Parkinson’s disease in the community setting.
Secondary ID [1] 287331 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 295970 0
Parkinson's disease 297774 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296251 296251 0 0
Speech therapy
Physical Medicine / Rehabilitation 298173 298173 0 0
Other physical medicine / rehabilitation
Oral and Gastrointestinal 305319 305319 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) uses an innovative hand-held treatment device titled the EMST 150 device that has been scientifically tested for its ability to improve muscle strength involved in swallowing. Expiratory muscle strength training intervention uses short duration, isometric contractions of the expiratory muscles to generate the maximum pressure to open the pressure release valve the handheld respiratory pressure threshold device. As the person progresses through the training program the pressure threshold device is adjusted incrementally, to increase the progressive load or effort. The resistance load is determined via measurement of the individuals’ maximum expiratory pressure (MEP) using a manometer, and setting the device to a percentage of this to ensure the intensity is close to the maximal loading of the muscle for strengthening. The intervention will involve a home practice program of 5 sets of 5 breaths (25 breaths) per session, completed seven days per week for six weeks. Participants are demonstrated how to use the device. Participants are provided with an instruction manual which include written and visual information regarding the intervention and maintenance program and will be asked to maintain a diary to record compliance with the regime, The participants just need to tick off when they have completed the daily session, or write down if they have missed a session. The diary and an instruction manual on how to complete the exercise will be provided by the researchers at the beginning of the training. Participants will attend the Community Therapy Services clinic once per week to be reviewed by a Speech Pathologist. The Community Therapy Services is the outpatient allied health rehabilitation service at Northern Health. During this weekly review session the EMST device we be calibrated each week to 75% of the participants Maximum Expiratory Pressure (MEP) and completion of the exercise will be reviewed. At the end of the 6 week program, A maintenance program will be recommended after this period for 4 weeks to maintain conditioning and prevent detraining. The maintenance program is not considered part of the intervention that is being measured in this project however is recommended to prevent de-training The maintenance program will involve a graded reduction with the exercises of 5 sets of 5 breaths (25 breaths) being completed 5 days per week for the first 2 weeks, and 3 days per week for the last 2 weeks. During the maintenance program the particpant will not visit the CTS but will be telephoned by the researcher each to week to monitor their status.
Intervention code [1] 292650 0
Rehabilitation
Intervention code [2] 294204 0
Treatment: Devices
Comparator / control treatment
A traditional rehabilitative approach that has been employed by Speech Pathologist for treatment of swallow dysfunction for alternate aetiologies (i.e. stroke) is the Effortful swallow. The Effortful swallow is a swallow specific manoeuvre that positively targets hyoid movement during swallowing. The Effortful swallow has been shown to increase hyoid vertical displacement, the duration of hyoid anterior excursion, duration of upper oesophageal opening and increase the amplitude of submental muscle activation in healthy adult participants. The Effortful swallow is an exercise used to strengthen the muscles in the throat that are important for swallowing. It is easy to complete and just needs the individual to put more effort into the swallow and squeeze the muscles in the throat.
The Effortful swallow intervention requires a home practice program that involves 5 sets x 5 (25 effortful swallows)per session of the effortful swallow exercise. Participants will be required to complete the exercises daily for 7 days per week for 6 weeks.
Participants will be asked to maintain a diary to record compliance with the regime, which will be provided by the researchers. The diary and an instruction manual on how to complete the exercise will be provided by the researchers at the beginning of the training. Participants will attend the Community Therapy Services clinic once per week to be reviewed by a Speech Pathologist and to monitor progress..
Control group
Active

Outcomes
Primary outcome [1] 295908 0
Changes in swallow function pre/post intervention will be identified by the primary outcome measure the Modified Barium Swallow Impairment Profile (MBSimp) which provides overall scores for oral and swallow function. The MBSimp will be completed pre/post the six week intervention programs via scoring of the pre/post Videofluoroscopy Swallowing Study (VFSS). Each participant will then attend a pre intervention and post intervention swallow X-ray (videofluoroscopic swallowing study) approximately one hour after taking their Parkinson’s disease medication.
The MBSimp will be completed pre and post a swallow x-ray (Videofluoroscopy Swallow Study). The clinician completing the MBSimp will be blinded to treatment group.
Timepoint [1] 295908 0
The pre-VFSS is completed before the 6 week intervention period is commenced and the post-VFSS is completed when the 6 week of intervention have been completed.
Secondary outcome [1] 316909 0
The Penetration and Aspiration Scale (PAS) is an 8 point interval scale used to score the degree of penetration and aspiration of fluid during swallowing. The PAS is completed post baseline VFSS and then again at the post VFSS after the 6 week intervention period.
Timepoint [1] 316909 0
Each participant will then attend a pre intervention and post intervention swallow X-ray (videofluoroscopic swallowing study) approximately one hour after taking their Parkinson’s disease medication.
The PAS will be completed pre and post swallow x-ray (Videofluoroscopy Swallow Study). The clinician completing the PAS will be blinded to treatment group
Secondary outcome [2] 321820 0
Surface Electromyography (sEMG) measuring activity of the submental muscles specifically involved in swallowing.
Timepoint [2] 321820 0
During the initial session and post completion of the six week home practice intervention the participant recording of swallow strength via sEMG will take place at the Commuity Therapy service clinic.
Secondary outcome [3] 321821 0
Swallowing Quality of Life Measure (SWAL-QOL)
Timepoint [3] 321821 0
Completion of a quality of life questionnaire relating to their swallow function (SWAL-QOL assessment) will be completed pre and post the six week intervention home practice programs at the Community Therapy Services Clinic

Eligibility
Key inclusion criteria
- Have a formal diagnosis of idiopathic Parkinson’s disease
- Able to provide informed consent. Consent may also be provided by a person who has legal authority to do so (e.g. carer, Next of Kin).
- Report some degree of swallowing impairment (e.g. reports coughing during eating a and drinking, food getting stuck in throat, increased eating duration)
- Age between 55 and 88
- Mini Mental Score > 24 or Mini Mental Score 22-23 with carer support.
- Preference for the participant to remain on the same Parkinson’s disease medications for the duration of the study
- Nil residual deficits from other neurological disorders, gastrointestinal disease, gastro-oesophageal surgery, head and neck cancer, history of respiratory disorders, untreated hypertension or heart disease
It is the preference of the researchers that participants will not change their medications relating to PD during the research trial as this may influence results. However, if this is necessary, participants will be asked to inform the researchers of any changes. They are also restricted from participating in any other Speech Pathology rehabilitative treatment during the study.
Minimum age
55 Years
Maximum age
88 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- MMSE < 24 and unable to complete daily home practice regime due to cognition/ nil carer support
- residual deficits from other neurological disorders, gastrointestinal disease, gastro-oesophageal surgery, head and neck cancer, history of respiratory disorders, untreated hypertension or heart disease
- nil dysphagia

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 concealed. Allocation involves contacting the holder of the allocation schedule who is located "off-site" or at another hospital campus.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Aiming to recruit 30-45 participants to this research project.
Descriptive statistics will be used to compare the primary and secondary outcome measures between the intervention and control groups at baseline and after the 6-week intervention period. Chi-squared and appropriate parametric and non-parametric continuous data statistical tests will be used to evaluate the effectiveness of the intervention for the primary and secondary outcomes. Standard practice measures MBSimP, PAS and sEMG activity will be analysed statistically via a repeated measures co-variance design (pre/post treatment). The swallowing Quality of Life Questionnaire (SWAL-QOL) will be analysed pre/post treatment. All statistical tests will be two-sided with a significance level of 0.05. Statistical analysis will be performed using Stata version 12.1 (StataCorp LP, Texas, USA). Interim analysis will not be completed for this research trial. Given that the MBSimp is a new rating tool and there is currently limited data available in regards to the estimates of the MBSImp outcome measure. Therefore an early stopping clause is not indicated for this trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/03/2015
Date of last participant enrolment
Anticipated
1/12/2018
Actual
17/09/2018
Date of last data collection
Anticipated
1/02/2019
Actual
3/12/2018
Sample size
Target
45
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5337 0
Bundoora Extended Care Centre - Bundoora
Recruitment hospital [2] 5338 0
Broadmeadows Health Service - Broadmeadows
Recruitment hospital [3] 5339 0
The Northern Hospital - Epping
Recruitment hospital [4] 5340 0
Craigieburn Health Service - Craigieburn

Funding & Sponsors
Funding source category [1] 292973 0
Hospital
Name [1] 292973 0
The Northern Hospital
Country [1] 292973 0
Australia
Primary sponsor type
Hospital
Name
Northern Health Foundation
Address
The Northern Hospital
185 Cooper Street Epping 3076
Victoria
Australia
Country
Australia
Secondary sponsor category [1] 297309 0
None
Name [1] 297309 0
Address [1] 297309 0
Country [1] 297309 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294474 0
Austin High Risk Ethics Commitee
Ethics committee address [1] 294474 0
Ethics committee country [1] 294474 0
Australia
Date submitted for ethics approval [1] 294474 0
11/11/2014
Approval date [1] 294474 0
19/01/2015
Ethics approval number [1] 294474 0
HREC/16/Austin/509

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2262 2262 0 0
/AnzctrAttachments/369171-Poster - Northern Health.pdf (Other)

Contacts
Principal investigator
Name 59742 0
Ms Marinda Brooks
Address 59742 0
The Northern Hospital
Northern Health
185 Cooper Street
Epping 3076
Victoria
Australia
Country 59742 0
Australia
Phone 59742 0
61 3 84058599
Fax 59742 0
Email 59742 0
marinda.brooks@nh.org.au
Contact person for public queries
Name 59743 0
Emma Beer
Address 59743 0
The Northern Hospital
Northern Health
185 Cooper Street
Epping 3076
Victoria
Country 59743 0
Australia
Phone 59743 0
61 3 83458868
Fax 59743 0
Email 59743 0
emma.beer@nh.org.au
Contact person for scientific queries
Name 59744 0
Marinda Brooks
Address 59744 0
The Northern Hospital
Northern Health
185 Cooper Street
Epping 3076
Victoria
Country 59744 0
Australia
Phone 59744 0
61 3 94953163
Fax 59744 0
Email 59744 0
marinda.brooks@nh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD sharing will not be allowed. This decision was made by the study group as it was not included in our ethics and our participants did not provide consent.


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.