Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000918426
Ethics application status
Approved
Date submitted
18/07/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Date data sharing statement initially provided
22/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
My Personal Rehab: A digital home-based program to improve physical function in older people undergoing rehabilitation
Scientific title
A pragmatic hybrid-type 1 randomised trial of digital home-based rehabilitation to improve mobility in older people requiring lower body rehabilitation services
Secondary ID [1] 314855 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reduced mobility 338139 0
Condition category
Condition code
Physical Medicine / Rehabilitation 334422 334422 0 0
Other physical medicine / rehabilitation
Musculoskeletal 334423 334423 0 0
Other muscular and skeletal disorders
Stroke 334424 334424 0 0
Ischaemic
Stroke 334425 334425 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: My Personal Rehab

This is a pragmatic, assessor-blinded, parallel-group, multi-site randomised controlled trial using a Hybrid Type 1 effectiveness-implementation design.

Physical or informational materials & procedures:

Participants in both groups will:
•Download the MyPersonalRehab app to access all participant-facing study resources including validated questionnaires and educational materials (developed for the purpose of this study).
• Receive a Garmin watch (free of charge) to track physical activity during the 6-month study.
• Complete questionnaires at the start, midway (3-months) and end of the study (6-months) taking up to 30-minutes each time. Complete short monthly surveys about physical activity, health services accessed, falls, and other adverse events, taking up to 5-minutes each time.


Participants in the digital rehabilitation program will:
• Continue with usual activities, and in addition:
• Use the StandingTall program: a home-based balance, mobility, strength and heart health exercise program. It features animations and instructions, assessments, progress tracking and motivational prompts. The intensity and difficulty of the program is individually tailored through baseline and ongoing balance and mobility assessments and continuous progress tracking. The program adjusts exercise prescription and difficulty based on user performance, confidence, and adherence. This ensures each participant receives a personalised and adaptive training plan that evolves with their ability. The program is accessed via a tablet, if participants do not have a tablet they will be loaned one for the duration of the study.
• Follow a tailored Walking Program: participants are able to start the walking program in Week 7 (depending on readiness, determined by questionnaire response to ‘Do you feel ready to add a daily walk to your routine?') and will continue until the end of the study, designed to engage participants in a structured walking plan to increase and/or maintain their daily walking levels. Participants will use a Garmin watch to help monitor the number of steps they have taken each day. Participants will receive a tailored daily walking target based on their baseline and ongoing activity levels.
•Receive Physical Activity Coaching digitally via the MyPersonalRehab app . This includes digital activities which aim to guide the participants to use motivational techniques to support adherence to the StandingTall and walking program. Coaching (via phone call) aims to support low adherers to start and/or continue StandingTall and/or the walking program using motivational techniques

• The goal is to gradually reach 2.5 hours of exercise each week, made up of StandingTall, the walking program, and any other activities (e.g. usual care exercises). This can be split into smaller sessions across the week. The programs are designed by Exercise Physiologists for digital, independent use at home. If participants do not meet program targets for two weeks in a row, they will be contacted by the research team.
• Health Education: Delivered every two weeks via the MyPersonalRehab app, this includes 13 short, evidence-based fact sheets over 6 months with more specific and prescriptive information designed to support the intervention, on topics relevant to rehabilitation, such as exercising safely, physical activity, falls, habit forming, common barriers to exercise, self-compassion
• Participants willing to participate in an optional interview or focus group (duration: 60-90 mins, either face-to-face or online, to share experiences and feedback, towards the end of the study) will be randomly allocated using stratified randomisation to ensure equal representation across age, gender, adherence, and rehabilitation indication

Adherence: Will be assessed via the Garmin watch to track walking, StandingTall application to track weekly exercise minutes, and education completion tracked via the MyPersonalRehab application.

Implementation strategies:
• To support delivery and uptake of the intervention, several pragmatic implementation strategies will be used. These include a site coordinator, central support via telehealth and use of embedded behaviour change techniques such as goal setting, feedback and monitoring, habit formation, and coaching. Onsite healthcare professionals will receive initial guidance and access to training materials to facilitate appropriate use of the My Personal Rehab platform.
Intervention code [1] 331464 0
Rehabilitation
Intervention code [2] 331465 0
Treatment: Other
Intervention code [3] 331466 0
Lifestyle
Comparator / control treatment
Participants in both groups will:
•Download the MyPersonalRehab app to access all participant-facing study resources including validated questionnaires and educational materials (developed for the purpose of this study).
• Receive a Garmin watch (free of charge) to track physical activity during the 6-month study.
• Complete questionnaires at the start, midway (3-months) and end of the study (6-months) taking up to 30-minutes each time. Complete short monthly surveys about any physical activity (including usual rehab activities), health services accessed, falls, and other adverse events that happened over the month, taking up to 5-minutes each time


Participants in the usual care group will:
• Be asked to continue with their usual outpatient rehab activities as provided by their treating clinicians. Information on what this entails will be captured by monthly questionnaires (detailed above in the ‘Participants in both groups will…’)
• Health Education: Delivered every two weeks via the My Personal Rehab app, this includes 13 short, evidence-based fact sheets over 6 months with general information on topics such as diet, mental health, sleep, physical activity, medication, fall prevention, and health conditions
Control group
Active

Outcomes
Primary outcome [1] 342120 0
Change in Physical function
Timepoint [1] 342120 0
Change from baseline to 6-months post-allocation, compared between control and intervention group
Secondary outcome [1] 449607 0
Change in Physical function
Timepoint [1] 449607 0
Change from baseline to 6-months post-allocation, compared between control and intervention group
Secondary outcome [2] 449614 0
Change in Physical function (lower body strength)
Timepoint [2] 449614 0
Change from baseline to 6-months post-allocation, compared between control and intervention group
Secondary outcome [3] 449615 0
Change in Physical function (walking speed)
Timepoint [3] 449615 0
Change from baseline to 6-months post-allocation, compared between control and intervention group
Secondary outcome [4] 449616 0
Change in Physical function (composite standing balance score)
Timepoint [4] 449616 0
Change from baseline to 6-months post-allocation, compared between control and intervention group
Secondary outcome [5] 449617 0
Change in daily step count over 26 weeks, assessed via weekly averages and analysed using a linear mixed-effects model with fixed effects for group, time (week), and their interaction, and a random intercept per participant; a random slope for time will be added if supported by model fit.
Timepoint [5] 449617 0
Group differences in mean daily step count at 3 and 6 months, estimated using marginal means from the mixed-effects model.
Secondary outcome [6] 449618 0
Incidental physical activity level
Timepoint [6] 449618 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [7] 449621 0
Planned Physical activity level
Timepoint [7] 449621 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [8] 449622 0
Exercise self-efficacy
Timepoint [8] 449622 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [9] 449623 0
Health-related quality of life
Timepoint [9] 449623 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [10] 449624 0
Emotional state of depression
Timepoint [10] 449624 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [11] 449625 0
Emotional states of anxiety 
Timepoint [11] 449625 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [12] 449626 0
Emotional states of stress
Timepoint [12] 449626 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [13] 449627 0
Mental wellbeing
Timepoint [13] 449627 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [14] 449628 0
Concerns about falling
Timepoint [14] 449628 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [15] 449629 0
Overall Health status
Timepoint [15] 449629 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [16] 449630 0
Goal Achievement
Timepoint [16] 449630 0
Change from baseline to 6-months post-allocation, compared between control and intervention group
Secondary outcome [17] 449631 0
Reported instances of serious adverse events related to the intervention e.g. falls, pain, cardiac arrest
Timepoint [17] 449631 0
Monthly for 6-months post allocation
Secondary outcome [18] 449632 0
Healthcare utilisation
Timepoint [18] 449632 0
Monthly for 6-months post allocation
Secondary outcome [19] 449633 0
Severity of pain
Timepoint [19] 449633 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [20] 449810 0
Impact/inference of pain
Timepoint [20] 449810 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [21] 449811 0
Cost-effectiveness
Timepoint [21] 449811 0
6-months post allocation
Secondary outcome [22] 449886 0
Perceived effectiveness (defined as self-reported change in mobility compared to baseline) (implementation outcome)
Timepoint [22] 449886 0
6-months post allocation
Secondary outcome [23] 449887 0
Adherence (defined as weekly exercise minutes captured through StandingTall and step count via smartwatch) (implementation outcome) (participant level)
Timepoint [23] 449887 0
6-months post allocation
Secondary outcome [24] 449889 0
Uptake of intervention delivery (defined as proportion of participants who completed at least 50% of the recommended dose of either StandingTall or walking, or both combined) (implementation outcome) (participant level)
Timepoint [24] 449889 0
6-months post allocation
Secondary outcome [25] 449890 0
Attrition (defined as the % of participants who discontinue using the program) (implementation outcome)
Timepoint [25] 449890 0
10-weeks and 6-months post allocation
Secondary outcome [26] 449891 0
Walking Physical activity level
Timepoint [26] 449891 0
Change from baseline to 3-months and 6-months post-allocation, compared between control and intervention group
Secondary outcome [27] 449892 0
Perceived usability of the program
Timepoint [27] 449892 0
6-months post allocation
Secondary outcome [28] 449893 0
Appropriateness (implementation outcome)
Timepoint [28] 449893 0
6-months post allocation
Secondary outcome [29] 449958 0
Feasibility (implementation outcome)
Timepoint [29] 449958 0
6-months post allocation
Secondary outcome [30] 449959 0
Acceptability (implementation outcome)
Timepoint [30] 449959 0
6-months post allocation
Secondary outcome [31] 449960 0
Qualitative assessment of participant experience and implementation perceptions (implementation outcome)
Timepoint [31] 449960 0
6-months post allocation
Secondary outcome [32] 450374 0
Reach (defined as % of eligible participants referred) (implementation outcome)
Timepoint [32] 450374 0
6-months post allocation
Secondary outcome [33] 450375 0
Qualitative assessment of health care professionals experience delivering digital rehabilitation and perceived effectiveness (implementation outcome)
Timepoint [33] 450375 0
Towards the end of the trial
Secondary outcome [34] 450646 0
Appropriateness (implementation outcome)
Timepoint [34] 450646 0
6-months post allocation
Secondary outcome [35] 450647 0
Feasibility (implementation outcome)
Timepoint [35] 450647 0
6-months post allocation
Secondary outcome [36] 450648 0
Adoption (defined as eligible health care professionals who referred at least 1 participant) (implementation outcome)
Timepoint [36] 450648 0
6-months post allocation
Secondary outcome [37] 450649 0
Acceptability (defined as % of health care professionals who referred 3+ participants) (implementation outcome)
Timepoint [37] 450649 0
6-months post allocation
Secondary outcome [38] 450671 0
Reach (defined as % of healthcare professionals who referred participants) (implementation outcome)
Timepoint [38] 450671 0
6 months post allocation
Secondary outcome [39] 450672 0
Fidelity Adherence (defined as any adaptation to what we delivered) (implementation outcome)
Timepoint [39] 450672 0
6 months post allocation
Secondary outcome [40] 450788 0
Fidelity (defined as the delivery of the program as per intended) (implementation outcome)
Timepoint [40] 450788 0
6-months post allocation

Eligibility
Key inclusion criteria
Inclusion criteria for Participant Group:

- Aged 50 years and over
-English-speaking
-Living in the community
-In need of rehabilitation services for lower body function
-Are deemed by their clinician to have the potential to improve mobility
-Willing to give written informed consent and participate in the study.

Inclusion criteria for Healthcare Professionals Group:

-Aged 18 years or older
-Employed at the study site
-Involved in the support and/or care of people aged 50 years and over in a rehabilitation setting
-English-speaking
-Willing to give written informed consent and participate in the study
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for Participant Group:

-Living in residential aged care before hospitalisation (not including respite care)
-Any medical condition that precludes exercise participation or inability to safely exercise at home without supervision
-Short Physical Performance Battery score >10 exclude (SPPB conducted at baseline assessment stage)
-Have a terminal illness or rapidly progressive neurological condition such as Parkinson’s disease, Multiple Sclerosis, Alzheimer’s disease, insufficient vision or hearing or acute psychiatric condition, or permanently wheelchair bound
-Unable to read and understand English
-Do not consent to study participation


Exclusion criteria for Healthcare Professionals Group:

-Are not employed at the study site in the capacity of providing support and/or care to people aged 50 years and over in a rehabilitation setting
-Unable to read and understand English
-Do not consent to study participation

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)
Eligible, consenting individuals will be randomly allocated to the intervention group (n = 297) or the usual care control group (n = 297) after completing baseline assessments. Allocation will be concealed by contacting the holder of the allocation schedule, who is located at a central administration site and is not involved in participant recruitment or assessment.


This process ensures that the individual enrolling participants does not know in advance which group the participant will be assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated using permuted block randomisation with block sizes of 2, 4 and 6, stratified by study site. The randomisation sequence will be created by a researcher who is not involved in participant recruitment or outcome assessment.

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
We estimate that a sample size of 594 participants (297 per group) would provide 80% power to detect a clinically meaningful between-group difference in SPPB of 1-point allowing for a site ICC of 0.05, 30% dropout rate and an alpha of 5%. This sample size was estimated to also be sufficient to detect between-group differences in the order of 10-15% of baseline values in our secondary outcomes.
This Hybrid Type 1 trial includes clinical mobility effectiveness (SPPB) as the primary outcome, with acceptability as a key implementation outcome

Analyses will use intention-to-treat principles and will be blinded for intervention allocation. Reporting of the trial will follow CONSORT guidelines. Data will be analysed using linear mixed models including a site random effect to account for between-site variability. Tests of direct and indirect effects will be conducted using the mediation package for R with inference based on bias-corrected and accelerated bootstrap estimates. Additional analyses will be carried out to account for the effect of intervention on baseline compliers (complier average causal effect, CACE) and survivors (survivor average causal effect, SACE). Reasons for non-compliance will be carefully examined to enable careful assessment of assumptions underlying estimation of the CACE and SACE.

Qualitative analysis of implementation outcomes will be guided by the CFIR 2.0 & RE-AIM to understand reasons for participation & non-participation at the organisational & individual levels (staff & clients). Implementation outcomes including acceptability, adoption, reach, effectiveness, fidelity, feasibility and maintenance will be explored. Transcripts will be coded deductively and inductively to identify key themes related to acceptability, feasibility, adoption, and sustainability of the intervention. Analysis will follow the steps of familiarisation, framework development, indexing, charting, and interpretation. Findings will be triangulated across data sources to inform implementation recommendations. Reporting will follow COREQ guideline

Cost-effectiveness will be assessed from a healthcare system perspective over the 6-month trial period. Quality-adjusted life years (QALYs) will be calculated using responses to the EQ-5D-5L. Healthcare resource use will be collected via monthly self-report and linked administrative data. Incremental cost-effectiveness ratios (ICERs) will be estimated by comparing costs and QALYs between groups. Sensitivity analyses will be conducted to assess robustness of findings.

Quantitative implementation outcomes (i.e., acceptability, adoption, reach, perceived effectiveness, fidelity, feasibility, maintenance) will be reported alongside clinical effectiveness outcomes in the main trial publication. The qualitative implementation substudy and the cost-effectiveness analysis will be reported in separate, dedicated publications.

While there are no specific diversity-related inclusion criteria, demographic data will be analysed to understand reach and engagement across underrepresented groups. Subgroup analyses may explore variation in reach and engagement by CALD background, or Aboriginal and Torres Strait Islander status, where numbers allow.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/09/2025
Actual
Date of last participant enrolment
Anticipated
8/09/2028
Actual
Date of last data collection
Anticipated
9/09/2030
Actual
Sample size
Target
594
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 319413 0
Government body
Name [1] 319413 0
Department of Health, Disability and Ageing - MRFF – Dementia, Ageing and Aged Care Mission – 2023 Dementia, Ageing and Aged Care Grant Proposal
Country [1] 319413 0
Australia
Funding source category [2] 319422 0
Government body
Name [2] 319422 0
NHMRC Investigator Grant (Prof Delbaere)
Country [2] 319422 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia (NeuRA)
Address
Country
Australia
Secondary sponsor category [1] 321910 0
None
Name [1] 321910 0
None
Address [1] 321910 0
Country [1] 321910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317984 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 317984 0
Ethics committee country [1] 317984 0
Australia
Date submitted for ethics approval [1] 317984 0
Approval date [1] 317984 0
29/01/2025
Ethics approval number [1] 317984 0
2024/ETH02689

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

Contacts
Principal investigator
Name 142778 0
Prof Kim Delbaere
Address 142778 0
Neuroscience Research Australia (NeuRA) 139 Barker Street, Randwick NSW 2031
Country 142778 0
Australia
Phone 142778 0
+61 02 9399 1066
Fax 142778 0
Email 142778 0
[email protected]
Contact person for public queries
Name 142779 0
Delbaere Team
Address 142779 0
Neuroscience Research Australia (NeuRA) 139 Barker Street, Randwick NSW 2031
Country 142779 0
Australia
Phone 142779 0
+61 02 9399 1083
Fax 142779 0
Email 142779 0
[email protected]
Contact person for scientific queries
Name 142780 0
A/Prof Kim S van Schooten
Address 142780 0
Neuroscience Research Australia (NeuRA) 139 Barker Street, Randwick NSW 2031
Country 142780 0
Australia
Phone 142780 0
+61 02 9399 1087
Fax 142780 0
Email 142780 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:
• Approved research investigators (must provide a methodologically sound proposal).
Available by emailing the data custodian ([email protected])

What individual participant data might be shared?
• De-identified individual participant data:
What types of analyses could be done with individual participant data?
• Consent is obtained for the research team to share or use the information collected in future research that will be specific to the aims of this research.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Beginning directly following main results publication and ending 15 years later (data retention period)

Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: By emailing the data custodian ([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.