Trial Review

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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)
Scientific title
Prospective cohort trial evaluating the feasibility and acceptability of combined respiratory training in people living with motor neurone disease
Secondary ID [1] 314506 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CHEST-MND: COHORT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor neurone disease 337577 0
Condition category
Condition code
Respiratory 333919 333919 0 0
Other respiratory disorders / diseases
Neurological 333920 333920 0 0
Neurodegenerative diseases
Physical Medicine / Rehabilitation 333921 333921 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 331131 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341570 0
Peak cough flow
Timepoint [1] 341570 0
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).
Secondary outcome [1] 447955 0
Participant’s perception of cough effectiveness
Timepoint [1] 447955 0
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).
Secondary outcome [2] 447956 0
Physiotherapist’s perception of participant’s cough effectiveness
Timepoint [2] 447956 0
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).
Secondary outcome [3] 447957 0
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Timepoint [3] 447957 0
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).
Secondary outcome [4] 447958 0
Bulbar function, as assessed using the Center for Neurological Study - Bulbar Function Scale (CNS-BFS)
Timepoint [4] 447958 0
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).
Secondary outcome [5] 447959 0
Dyspnea
Timepoint [5] 447959 0
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).
Secondary outcome [6] 447967 0
Quality of life (EQ-5D-5L)
Timepoint [6] 447967 0
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).
Secondary outcome [7] 447969 0
Disease specific quality of life: the Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ)
Timepoint [7] 447969 0
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).
Secondary outcome [8] 447972 0
Exercise therapy burden
Timepoint [8] 447972 0
Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
Secondary outcome [9] 447973 0
Self-reported cough characterisation
Timepoint [9] 447973 0
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).
Secondary outcome [10] 447974 0
Exercise therapy usage
Timepoint [10] 447974 0
Follow-up visits (frequency as per usual clinical care, with maximum duration of follow-up being to December 2026).
Secondary outcome [11] 448481 0
Feasibility and Acceptability of exercise therapy
Timepoint [11] 448481 0
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)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent
Unable to complete English-language surveys

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
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 319045 0
Charities/Societies/Foundations
Name [1] 319045 0
Motor Neurone Disease Research Australia
Country [1] 319045 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 321511 0
None
Name [1] 321511 0
Address [1] 321511 0
Country [1] 321511 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317652 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 317652 0
Ethics committee country [1] 317652 0
Australia
Date submitted for ethics approval [1] 317652 0
07/11/2024
Approval date [1] 317652 0
19/05/2025
Ethics approval number [1] 317652 0
HREC/114451/Austin-2024

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

Contacts
Principal investigator
Name 141702 0
Dr Nicole Sheers
Address 141702 0
Melbourne School of Health Sciences at Austin Health; Level 5 Harold Stokes Building, 145 Studley Road; Heidelberg; VIC 3084
Country 141702 0
Australia
Phone 141702 0
+61 468 862 693
Fax 141702 0
Email 141702 0
[email protected]
Contact person for public queries
Name 141703 0
Nicole Sheers
Address 141703 0
Melbourne School of Health Sciences at Austin Health; Level 5 Harold Stokes Building, 145 Studley Road; Heidelberg; VIC 3084
Country 141703 0
Australia
Phone 141703 0
+61 468 862 693
Fax 141703 0
Email 141703 0
[email protected]
Contact person for scientific queries
Name 141704 0
Nicole Sheers
Address 141704 0
Melbourne School of Health Sciences at Austin Health; Level 5 Harold Stokes Building, 145 Studley Road; Heidelberg; VIC 3084
Country 141704 0
Australia
Phone 141704 0
+61 468 862 693
Fax 141704 0
Email 141704 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?
• De-identified individual participant data:
• All outcomes data
• Published results
• 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
• 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.