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Trial registered on ANZCTR
Registration number
ACTRN12625000621415
Ethics application status
Approved
Date submitted
23/05/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Combined Hyperinflation and Expiratory Strength Training in People Living with Motor Neurone Disease (CHEST-MND: COHORT)
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Scientific title
Prospective cohort trial evaluating the feasibility and acceptability of combined respiratory training in people living with motor neurone disease
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Secondary ID [1]
314506
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
CHEST-MND: COHORT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Motor neurone disease
337577
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Condition category
Condition code
Neurological
333920
333920
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0
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Neurodegenerative diseases
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Physical Medicine / Rehabilitation
333921
333921
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0
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Physiotherapy
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Respiratory
333919
333919
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
People with motor neurone disease (MND) who are receiving physiotherapy services within their usual MND care pathway, AND for whom lung volume recruitment (LVR) and expiratory muscle strength training (EMST) are being recommended, will be eligible to participate in this cohort study.
Therapy description: LVR uses a self-inflating bag (similar to a resuscitation bag) with a mouthpiece or mask to deliver consecutive insufflations (i.e., large “puffs” of air), to “stack” a larger volume of air than can be inspired spontaneously. EMST uses a spring-loaded pressure threshold device to provide resistance as one breaths out (e.g. EMST 75 or EMST 150 device). The therapy in this study combines these two devices, so that a person "stacks" a volume of air in using the LVR bag, and then exhales through the resistive training device.
The decision to trial LVR+EMST will be made by the treating physiotherapist in collaboration with the PlwMND, as per usual service provision, person-centred care practice and clinical reasoning.
Participants will be trained in LVR+EMST by their treating physiotherapist, within a usual clinical visit (estimated clinic duration ~ 30 minutes). Participants will be advised to continue the exercise on their own/with carers at home. Follow-up contact with their treating physiotherapist is as per usual practice - typically this would involve a telehealth or face-to-face appointment where the clinician reviews a person's progress, modifies technique and/or dosage, at a time determined by clinical presentation (i.e., number of weeks/months post initial assessment for review varies according to local service).
Rationale for recommending LVR+EMST and dosage (e.g. number of repetitions, sets and frequency) will be as directed by the treating physiotherapist. A repetition consists of an individually prescribed number of compressions via the LVR bag to reach the maximal tolerated insufflation capacity, followed by a forceful expiration through the EMST device, typical set at 50% of the participant’s maximal expiratory pressure (MEP). Adherence with the prescribed intervention regimen will be assessed via participant self-report training diary, as per common clinical practice. Some participants may have adherence objectively measured via a time-stamped data logger fitted to the LVR+EMST kit.
Follow-up of participants is as per usual clinical care (usually three-monthly but may be more frequent in the period following commencement of physiotherapy interventions such as LVR+EMST). Participants in this cohort study will be followed for at least one visit post cohort entry. Cohort end date will coincide with any of the events below. As such, the total duration of the treating period will be variable, and largely at the participant's own discretion
- Clinical visit where decision is communicated to cease performing LVR+EMST
- Participant’s wish to withdrawal from the cohort
- End of study data collection period (December 2026)
At the end of their study involvement, participants will be invited to participate in a semi-structured interview. The participant will be able to freely opt-out of the interview at this time without it affecting their participation in this study or future studies. For those who agree to the interview, a member of the central research team will arrange a time to conduct the interview. Interviews will be conducted by an experienced qualitative researcher, independent from the treating physiotherapist known to the participant. Interviews will be conducted on a sub-group of participants until data saturation has been achieved, which we anticipate will occur after 10 to 15 interviews.
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Intervention code [1]
331131
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Rehabilitation
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Peak cough flow
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Assessment method [1]
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Peak expiratory flow rate measured as the participant performs an unassisted cough into an oronasal mask
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Timepoint [1]
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Cohort entry (the clinical visit at which the treating physiotherapist introduces LVR+EMST) and Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
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Secondary outcome [1]
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Feasibility and Acceptability of exercise therapy
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Assessment method [1]
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Qualitative data, obtained via semi-structured interviews with participants +/- carers. At the end of their study involvement, participants will be invited to participate in a semi-structured interview. The participant will be able to freely opt-out of the interview at this time without it affecting their participation in this study or future studies. For those who agree to the interview, a member of the central research team will arrange a time to conduct the interview. Interviews will be conducted by an experienced qualitative researcher, independent from the treating physiotherapist known to the participant. Interviews will be conducted by telephone/videoconference (e.g., Zoom or Microsoft Teams) at a time suitable for the participant and are expected to take approximately 30-45 minutes. Interview analysis will be guided by the Theoretical Framework of Acceptability and the COM-B model.
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Timepoint [1]
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Cohort end date, which will be determined by any of the events below: - Clinical visit where decision is communicated to cease performing LVR+EMST - Participant’s wish to withdrawal from the cohort - End of study data collection period (December 2026)
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Secondary outcome [2]
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Dyspnea
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Assessment method [2]
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The amyotrophic lateral sclerosis (ALS) respiratory symptom scale (ARES) is a 12-item patient-report scale indexing the degree of dyspnea with each question rated on a scale from 0 (no dyspnea) to 10 (severe dyspnea), and total score ranging from 0 (no dyspnea) to 120 (severe dyspnea).
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Timepoint [2]
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Cohort entry (the clinical visit at which the treating physiotherapist introduces LVR+EMST) and Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
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Secondary outcome [3]
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Physiotherapist’s perception of participant’s cough effectiveness
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Assessment method [3]
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Marked with a "X" on a 10cm long visual analogue scale, asking "how effective do you think your client's cough is today?", with anchors "ineffective cough" and "effective cough"
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Timepoint [3]
447956
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Cohort entry (the clinical visit at which the treating physiotherapist introduces LVR+EMST) and Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
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Secondary outcome [4]
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Disease specific quality of life: the Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ)
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Assessment method [4]
447969
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The Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ) is a patient self-report health status PROM. The ALSAQ is specifically used to measure the subjective well-being of patients with amyotrophic lateral sclerosis. This study will use the short form 5-item version of the ALSAQ (ALSAQ-5).
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Timepoint [4]
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Cohort entry (the clinical visit at which the treating physiotherapist introduces LVR+EMST) and Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
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Secondary outcome [5]
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Self-reported cough characterisation
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Assessment method [5]
447973
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16 questions, regarding cough characteristics and self-reported effectiveness. This questionnaire has been developed specifically for this study as no validated questionnaire currently exists.
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Timepoint [5]
447973
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Cohort entry (the clinical visit at which the treating physiotherapist introduces LVR+EMST) and Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
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Secondary outcome [6]
447957
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Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
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Assessment method [6]
447957
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A validated instrument for monitoring the progression of functional disability in people with ALS/MND, and marker of disease severity. The ALSFRS-R is a 12-item scale, with questions across upper limb, lower limb, bulbar and respiratory domains rated on a scale from 0 to 4.
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Timepoint [6]
447957
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Cohort entry (the clinical visit at which the treating physiotherapist introduces LVR+EMST) and Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
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Secondary outcome [7]
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Quality of life (EQ-5D-5L)
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Assessment method [7]
447967
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The EQ-5D-5L is a standardised measure of health status to provide a simple, generic measure of health for clinical and economic analysis. The EQ-5D-5L comprises a 5-item descriptive questionnaire comprising five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), and a visual analogue scale.
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Timepoint [7]
447967
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Cohort entry (the clinical visit at which the treating physiotherapist introduces LVR+EMST) and Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
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Secondary outcome [8]
447955
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Participant’s perception of cough effectiveness
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Assessment method [8]
447955
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Marked with a "X" on a 10cm long visual analogue scale, asking "how effective do you think your cough is today?", with anchors "ineffective cough" and "effective cough"
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Timepoint [8]
447955
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Cohort entry (the clinical visit at which the treating physiotherapist introduces LVR+EMST) and Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
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Secondary outcome [9]
447958
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Bulbar function, as assessed using the Center for Neurological Study - Bulbar Function Scale (CNS-BFS)
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Assessment method [9]
447958
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The Center for Neurological Study - Bulbar Function Scale (CNS-BFS) is a 21-item validated, patient-reported scale indexing degree of bulbar dysfunction in the domains of speech, salivation, and swallowing. The CNS-BFS total score will be used to assess overall bulbar function as a composite measure.
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Timepoint [9]
447958
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Cohort entry (the clinical visit at which the treating physiotherapist introduces LVR+EMST) and Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
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Secondary outcome [10]
447972
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Exercise therapy burden
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Assessment method [10]
447972
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Burden will also be measured using the Exercise Therapy Burden Questionnaire (ETBQ). The ETBQ is a 10-item questionnaire specifically assessing the global burden related to the prescribed exercise regimen in chronic health conditions. Each question addresses different aspects of the exercise program (i.e., pain, fatigue, difficulty, time) and is rated on a scale from 0 (totally disagree) to 10 (totally agree), for a total score of 0 (no burden) to 100 (significant burden)
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Timepoint [10]
447972
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Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
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Secondary outcome [11]
447974
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Exercise therapy usage
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Assessment method [11]
447974
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Measure of adherence with intervention. Usually recorded via self-report from participant or completion of exercise diary. Sub-sample of participants will have usage measured by LVR counter attached to LVR+EMST device
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Timepoint [11]
447974
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Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
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Eligibility
Key inclusion criteria
People living with MND who are receiving physiotherapy services within their usual MND care pathway, at participating trial sites, AND for whom LVR and EMST are being recommended by their treating physiotherapist
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Unable to provide informed consent
Unable to complete English-language surveys
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last participant enrolment
Anticipated
30/09/2026
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
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Funding & Sponsors
Funding source category [1]
319045
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Charities/Societies/Foundations
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Name [1]
319045
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Motor Neurone Disease Research Australia
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Address [1]
319045
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Country [1]
319045
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Australia
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Primary sponsor type
University
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Name
The University of Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
321511
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None
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Name [1]
321511
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Address [1]
321511
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Country [1]
321511
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317652
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
317652
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
317652
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Australia
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Date submitted for ethics approval [1]
317652
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07/11/2024
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Approval date [1]
317652
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19/05/2025
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Ethics approval number [1]
317652
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HREC/114451/Austin-2024
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Summary
Brief summary
Breathing and coughing difficulties are extremely distressing for people living with MND, and therapies that improve breathing capacity and related symptoms are needed. This research project will evaluate whether combining two breathing therapies together (lung volume recruitment with expiratory muscle strength training) is feasible and acceptable to people living with MND and clinicians (e.g. physiotherapists trialing the intervention with people). This observational study will also collect information about whether the combined therapy improves breathing and cough symptoms in people affected by MND.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Nicole Sheers
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Address
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Melbourne School of Health Sciences at Austin Health; Level 5 Harold Stokes Building, 145 Studley Road; Heidelberg; VIC 3084
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Country
141702
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Australia
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Phone
141702
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+61 468 862 693
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Fax
141702
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Email
141702
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[email protected]
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Contact person for public queries
Name
141703
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Nicole Sheers
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Address
141703
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Melbourne School of Health Sciences at Austin Health; Level 5 Harold Stokes Building, 145 Studley Road; Heidelberg; VIC 3084
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Country
141703
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Australia
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Phone
141703
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+61 468 862 693
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Fax
141703
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Email
141703
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[email protected]
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Contact person for scientific queries
Name
141704
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Nicole Sheers
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Address
141704
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Melbourne School of Health Sciences at Austin Health; Level 5 Harold Stokes Building, 145 Studley Road; Heidelberg; VIC 3084
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Country
141704
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Australia
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Phone
141704
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+61 468 862 693
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Fax
141704
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Email
141704
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[email protected]
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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:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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Requires a scientifically sound proposal or protocol
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Requires approval by an ethics committee
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Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
•
De-identified individual participant data:
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All outcomes data
•
Published results
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Primary outcome(s)
•
Safety data
What types of analyses could be done with individual participant data?
•
Systematic reviews and meta-analyses
•
Studies exploring new research questions
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Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
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:
Proposals to analyse individual participant data will be directed to the principal investigator, Dr Nicole Sheers, via email:
[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.
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