Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001305314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
6/10/2026
Date registered
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29/10/2026
Date last updated
Help: Date last updated
29/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
29/10/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A co-designed exercise promotion program for multiple sclerosis (MS) healthcare providers and people with MS
Scientific title
A three-stage, mixed-methods, single-arm, non-randomised implementation trial of a co-designed exercise promotion training program (PULSE-HCP) for multiple sclerosis healthcare providers and its effect on exercise participation in people with multiple sclerosis
Additional trial identifiers [1] 318587 0
None
Universal Trial Number (UTN)
Trial acronym
PULSE-HCP
Related trial records

Health condition
Health condition(s) studied:
Multiple sclerosis 343792 0
Condition category
Condition code
Neurological 339920 339920 0 0
Multiple sclerosis
Public Health 339921 339921 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
PULSE-HCP (Provider Education in Using Strategies for Exercise Promotion in MS) is a healthcare professional education intervention designed to improve the conversation around evidence-based exercise promotion in routine MS clinical care. The study is a three-stage, mixed-methods, single-arm, non-randomised implementation trial involving healthcare professionals (HCPs; Population 1) and people with MS (PwMS; Population 2).

The three stages will run sequentially for each cohort. Stage 2 will begin once all Stage 1 interviews are complete and the training program has been refined, which is expected to take approximately 4 months. Stage 3 will run alongside Stage 2, with each HCP recruiting their two patients with MS once they have completed the PULSE-HCP training, and delivering the study consultations within the 20 working day logging period /4-6 weeks after completing the training.

Stage 1: HCP (Pilot testing and refinement of training program)
Stage 1 will comprise two interconnected components: user-testing and refinement. Six HCPs will complete a preliminary version of the PULSE-HCP online training program delivered through a secure learning management system, available, self-paced, over a one-month period. The program comprises six modules covering: (1) introduction to the PULSE-HCP toolkit, (2) MS foundations for exercise promotion, (3) Exercise evidence and safety considerations (including how to screen for patients at risk of exercise-related adverse events), (4) Evidence-based exercise guidelines for PwMS, (5) Behaviour change theories and strategies, and (6) Patient communication techniques, clinical scenarios, referral pathways and implementation strategies. Each module will be followed by an embedded formative quiz to assess HCP knowledge. Within two weeks of completing the training and quizzes, each HCP will take part in one semi-structured online interview, conducted via Microsoft Teams/Zoom by a member of the research team (e.g. the Project Manager), lasting approximately 45-60 minutes and exploring feedback on the training program. Interview findings will be used to refine the intervention content, structure, educational materials and implementation resources before stage 2.

Stage 2: HCP (PULSE-HCP training)
For a new cohort of 33 HCPs, the refined intervention (updated following stage 1) will similarly consist of a self-paced online training program delivered through a secure learning management system available, self-paced, over a one-month period. The program will comprise the refined modules and knowledge quizzes as outlined in stage 1. HCPs complete online questionnaires before starting the training (Baseline), immediately after completing the training and one-month after completing the training.

Exercise promotion activity log: At the completion of the training program, HCPs will be instructed to keep an exercise promotion activity log over 20 working days. They will be provided with a template and instructed to record the total number of patients with MS they consulted and from those consultations the number of patients with MS for whom they discussed exercise, provided exercise education material and/or whether referrals to exercise professionals were made. The exercise promotion log will not capture any patient-identifying information but will instead capture aggregated, non-identifiable counts of clinical activity (i.e., “discussed exercise with 3 patients today”), as opposed to whom this was discussed with.

Individual patient consultation log: HCPs will also be instructed to keep an individual patient consultation log, specific to their patients with MS who enrol as participants in stage 3 (described below). HCPs will be provided with a template to record whether exercise was discussed with these patients, whether education materials were provided, whether referrals to exercise professionals were made and/or whether they identified any risks of adverse events related to exercise participation.

To support intervention fidelity, in module 6, HCPs will be trained to include the following minimum components in each study consultation with patients enrolled in stage 3: (1) Stage 1 of the Adult Pre-Exercise Screening System questionnaire to identify patients at higher risk of adverse events due to exercise; (2) Discussion of evidence-based exercise recommendations for people with MS; (3) Discussion of current exercise participation; (4) Identification of barriers and facilitators to exercise engagement; (5) Exercise-promotion and behaviour-change discussion, including encouragement, problem-solving and goal setting where appropriate; (6) Information regarding referral pathways to exercise specialists where clinically appropriate; and (7) Provision of information regarding local exercise opportunities, community programs, MS-specific services or relevant exercise resources. HCPs will be provided a consultation checklist to ensure minimum intervention components are addressed, while allowing discussions to remain personalised and reflective of routine clinical practice.

Stage 3: PwMS (The consultation)
After completing the PULSE-HCP training program, each HCP will deliver a single exercise-promotion consultation to two of their patients with MS who have enrolled in stage 3 of the trial. The consultation will take place within the patient’s normal clinical care (~15-20 minute usual consult) and is estimated to take ~3-4 minutes of that. The consult will be tailored to the individual’s symptoms, functional ability, current exercise participation, personal goals, comorbidities and access to local services. Participants continue to receive their usual MS care. The consultation will address the seven minimum components discussed under Stage 2 (above).

Participants with MS will complete online questionnaires before the HCP consultation (Baseline), immediately after the consultation and one-month after the consultation, and wear an accelerometer for 7 days to monitor physical activity.
Intervention code [1] 335491 0
Lifestyle
Intervention code [2] 335492 0
Behaviour
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 347092 0
Change in HCP self-confidence to promote exercise (Stage 2; HCP).
Timepoint [1] 347092 0
Baseline (Week 0, pre-training), immediately post-training, and 1-month post-training.
Primary outcome [2] 347093 0
Change in exercise participation among PwMS (Stage 3; PwMS).
Timepoint [2] 347093 0
Baseline (Week 0) and 1-month post-consultation follow-up.
Secondary outcome [1] 468887 0
Feedback of the preliminary PULSE-HCP training program (Stage 1; HCPs).
Timepoint [1] 468887 0
Within two weeks of completing the preliminary PULSE-HCP training program.
Secondary outcome [2] 468888 0
HCP knowledge of exercise promotion in MS (Stage 2; HCP).
Timepoint [2] 468888 0
On completion of each of the six training modules.
Secondary outcome [3] 468889 0
Actual exercise-promotion behaviours in clinical practice (Stage 2; HCP). This is a composite secondary outcome.
Timepoint [3] 468889 0
Collected over the 1-month period following training and submitted at 1-month post-training follow-up
Secondary outcome [4] 468890 0
Intervention acceptability, appropriateness and implementation potential (Stage 2; HCPs and Stage 3; PwMS). This is a composite secondary outcome.
Timepoint [4] 468890 0
1-month post-training follow up
Secondary outcome [5] 468891 0
Feasibility: recruitment (Stage 2; HCPs and Stage 3; PwMS).
Timepoint [5] 468891 0
At the end of the recruitment period.
Secondary outcome [6] 468892 0
Feasibility: retention (Stage 2; HCPs and Stage 3; PwMS).
Timepoint [6] 468892 0
1-month post-training (HCPs) and 1-month post-consultation (PwMS).
Secondary outcome [7] 468893 0
Feasibility: assessment completion (Stage 2; HCPs and Stage 3; PwMS).
Timepoint [7] 468893 0
Baseline, immediately post-training/consultation and 1-month post-training/consultation.
Secondary outcome [8] 468894 0
Feasibility: engagement with the intervention (Stage 2; HCPs).
Timepoint [8] 468894 0
On completion of the PULSE-HCP training program.
Secondary outcome [9] 468895 0
Training time for costing (Stage 2; HCPs).
Timepoint [9] 468895 0
On completion of the PULSE-HCP training program.
Secondary outcome [10] 468896 0
Change in determinants of implementation behaviour for exercise promotion (Stage 2; HCPs).
Timepoint [10] 468896 0
Baseline, immediately post-training and 1-month post-training.
Secondary outcome [11] 469545 0
Implementation intention for exercise promotion (Stage 2; HCPs).
Timepoint [11] 469545 0
Immediately post-training and 1 month post-training.
Secondary outcome [12] 469546 0
Step counts of participants with MS (Stage 3; PwMS)
Timepoint [12] 469546 0
A 7-day wear period during the month following the consultation.
Secondary outcome [13] 469547 0
Self-efficacy (Stage 3; PwMS)
Timepoint [13] 469547 0
Baseline, within 1-week post-consultation and approximately 1 month post-consultation.
Secondary outcome [14] 469548 0
Adverse events (Stage 3; PwMS)
Timepoint [14] 469548 0
Within 1 week post-consultation and approximately 1 month post-consultation.

Eligibility
Key inclusion criteria
Stage 1/2:
- A neurologist, nurse, or other medical professional
- 18 years of age or older
- MS comprises >20% of their caseload in the last 18 months
- Living and working in Australia
- Willing to review (Stage 1) and receive (Stage 2) the PULSE-HCP intervention
- Willing to complete all data collection procedures

Stage 3:
- 18 years of age or older
- Confirmed self-reported diagnosis of MS
- Are able to walk with or without a mobility aid(s)
- No MS relapse within previous month prior to enrolment
- Currently living in Australia
- Willing to complete all study procedures
Minimum age
18 Years
Maximum age
84 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Stage 1:
- Exercise specialist (i.e., physiotherapist, exercise physiologist or occupational therapist)
- Inability to understand and communicate in the English language

Stage 2:
- Exercise specialist (i.e., physiotherapist, exercise physiologist or occupational therapist)
- Has participated in Stage 1 of this research
- Inability to understand and communicate in the English language

Stage 3:
- Inability to understand and communicate in the English language

Study design
Purpose of the study
Educational / counselling / training
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
Statistical methods / analysis
Sample size: At least 6 HCPs will be recruited for stage 1, allowing diversity of views. For stage 2, 33 HCPs will be recruited allowing for a 30% attrition rate. For Stage 3, 66 people with MS will be recruited (two per HCP), giving each HCP more than one opportunity to apply the training in routine practice. Stage 1-3 is not powered for effectiveness.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/03/2028
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 323164 0
Charities/Societies/Foundations
Name [1] 323164 0
MS Australia
Country [1] 323164 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 326126 0
None
Name [1] 326126 0
Address [1] 326126 0
Country [1] 326126 0
Other collaborator category [1] 284121 0
Individual
Name [1] 284121 0
Olivia Wills, University of New South Wales
Address [1] 284121 0
Country [1] 284121 0
Australia
Other collaborator category [2] 284122 0
Individual
Name [2] 284122 0
Claudia Marck, University of Melbourne
Address [2] 284122 0
Country [2] 284122 0
Australia
Other collaborator category [3] 284123 0
Individual
Name [3] 284123 0
Marlena Klaic, University of Melbourne
Address [3] 284123 0
Country [3] 284123 0
Australia
Other collaborator category [4] 284124 0
Individual
Name [4] 284124 0
Yasmine Probst, University of Wollongong
Address [4] 284124 0
Country [4] 284124 0
Australia
Other collaborator category [5] 284125 0
Individual
Name [5] 284125 0
Robert Motl, University of Illinois
Address [5] 284125 0
Country [5] 284125 0
United States of America
Other collaborator category [6] 284126 0
Individual
Name [6] 284126 0
Sarah Donkers, University of Saskatchewan
Address [6] 284126 0
Country [6] 284126 0
Canada
Other collaborator category [7] 284127 0
Individual
Name [7] 284127 0
Allan Kermode, Murdoch University & Perron Institute for Neurological and Translational Science
Address [7] 284127 0
Country [7] 284127 0
Australia
Other collaborator category [8] 284128 0
Individual
Name [8] 284128 0
Heidi Beadnall, University of Sydney and Brain and Mind Centre
Address [8] 284128 0
Country [8] 284128 0
Australia
Other collaborator category [9] 284129 0
Individual
Name [9] 284129 0
Susan Slatyer, Murdoch University
Address [9] 284129 0
Country [9] 284129 0
Australia
Other collaborator category [10] 284130 0
Individual
Name [10] 284130 0
Shoroog Allogmanny, University of Tabiah
Address [10] 284130 0
Country [10] 284130 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321569 0
The University of New South Wales Committee B
Ethics committee address [1] 321569 0
Ethics committee country [1] 321569 0
Australia
Date submitted for ethics approval [1] 321569 0
25/05/2026
Approval date [1] 321569 0
20/10/2026
Ethics approval number [1] 321569 0
iRECS11672

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

Contacts
Principal investigator
Name 154106 0
A/Prof Yvonne Learmonth
Address 154106 0
Health Translation Hub, University of New South Wales; Level 6, 55 Botany St, Randwick NSW 2031
Country 154106 0
Australia
Phone 154106 0
+61 2 9348 2664
Fax 154106 0
Email 154106 0
[email protected]
Contact person for public queries
Name 154107 0
Yvonne Learmonth
Address 154107 0
Health Translation Hub, University of New South Wales; Level 6, 55 Botany St, Randwick NSW 2031
Country 154107 0
Australia
Phone 154107 0
+61 2 9348 2664
Fax 154107 0
Email 154107 0
[email protected]
Contact person for scientific queries
Name 154108 0
Yvonne Learmonth
Address 154108 0
Health Translation Hub, University of New South Wales; Level 6, 55 Botany St, Randwick NSW 2031
Country 154108 0
Australia
Phone 154108 0
+61 2 9348 2664
Fax 154108 0
Email 154108 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: We will not share individual participant data beyond this project because participants will consent to its use solely within the project's scope. This decision respects our ethical responsibility to protect participant privacy and complies with institution policy and data protection requirements.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Statistical analysis plan    Statistical methods.docx


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.