Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000096459
Ethics application status
Approved
Date submitted
20/12/2024
Date registered
29/01/2025
Date last updated
29/01/2025
Date data sharing statement initially provided
29/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
GRIP (Group Run Virtual Physiotherapy): A pilot study examining the feasibility of providing a physiotherapy-led falls prevention group exercise class via telehealth
Scientific title
GRIP (Group Run Virtual Physiotherapy): A pilot study examining the feasibility of providing a physiotherapy-led falls prevention group exercise class via telehealth for individuals aged 65 years or older self-reporting a decline in balance
Secondary ID [1] 313604 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GRIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fall Prevention 336148 0
Exercise in older adults 336150 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332698 332698 0 0
Physiotherapy
Public Health 332697 332697 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants included in the study will be recruited from RPA Virtual Hospital who meet a specific eligibility criteria. They will partake in a 12-week virtual falls prevention service that includes assessment and delivery of exercise.
Initial assessment will be conducted via videoconference using Teams in the participants home. It will be a one hour one-on-one assessment conducted by a physiotherapist

There will be 4 x 1 hour exercise sessions in Weeks 1, 3, 6 and 9 of the 12 week exercise program. This will be conducted via Teams and include 4 participants supervised by the physiotherapist. Participants will join from their home. Exercises will include lower limb balance and strength based exercises, at a low to moderate intensity (as assessed by patient reported perceived exertion).
- Participants will be asked to perform an independent home exercise program 3-4x per week for 30 minutes (aiming for 2 hours per week) for the 12 week program.
- A session attendance checklist will be taken to record adherence to the group classes, and patients will be asked at the end of the intervention whether they completed the individual exercise program
Intervention code [1] 330201 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340224 0
Acceptability and Suitability of a virtual falls prevention program. This will be assessed as a composite primary outcome
Timepoint [1] 340224 0
Baseline = ask the Likert scale 7 week post commencement of program = qualitative semi-structured interview 12 weeks post commencement of program = Likert scale
Secondary outcome [1] 443821 0
Quality of Life score
Timepoint [1] 443821 0
Measured at baseline and 12 weeks post commencement of program
Secondary outcome [2] 443396 0
Physical outcomes
Timepoint [2] 443396 0
Baseline and 12 weeks post commencement of program
Secondary outcome [3] 443820 0
Physical activity records
Timepoint [3] 443820 0
Measure at baseline AND at the 12 weeks post commencement of program
Secondary outcome [4] 444094 0
Physical Outcome
Timepoint [4] 444094 0
Baseline and 12 weeks post commencement of program
Secondary outcome [5] 444090 0
Physical Outcome
Timepoint [5] 444090 0
Baseline and 12 weeks post commencement of program
Secondary outcome [6] 443819 0
Number of falls
Timepoint [6] 443819 0
12 weeks post commencement of program

Eligibility
Key inclusion criteria
• Participants with stable health who are at lower risk of an adverse event during exercise
• Individuals who have experienced a self-reported decline in balance, a recent near fall or fall in the last two years
• Age: 65 years or older
• Sufficient sensory, neurological, cognitive, and English language skills for exercise and video-based interventions
• Discharged from one of RPA Virtual Hospital’s services including Virtual Fracture Clinic, Virtual Rehabilitation or Virtual Trauma in the past 12 months OR a current patient being treated within the Sydney District Nursing (not including palliative care patients)
• Able to transfer independently without physical assistance and walk 10 or more metre +/- walking aid
• Living in the community in private home (not in a residential aged care facility)
• Have internet connectivity and access to a mobile or tablet device
• Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age: less than 65 years old
• Are expected to live for less than 6 months as determined by their primary care physician
• Have participated in a similar physiotherapy program in the last 12 months
• Have physical, sensory, mental health or behavioural issues that would prevent participation in the intervention as identified by medical practitioner
• Have acute or unstable cardiac or respiratory conditions
• Have poorly controlled blood pressure or diabetes
• Have acute or unstable musculoskeletal conditions such as recent fractures (< 6 weeks), neurological compromise or disc prolapse
• Cannot transfer independently (without physical assistance) or walk 10 or more metres +/- a walking aid

Study design
Purpose of the study
Prevention
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
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
6/01/2025
Date of last participant enrolment
Anticipated
Actual
21/01/2025
Date of last data collection
Anticipated
26/04/2025
Actual
Sample size
Target
12
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318074 0
Hospital
Name [1] 318074 0
RPA Virtual Hospital
Country [1] 318074 0
Australia
Primary sponsor type
Hospital
Name
RPA Virtual Hospital
Address
Country
Australia
Secondary sponsor category [1] 320429 0
University
Name [1] 320429 0
University of Sydney
Address [1] 320429 0
Country [1] 320429 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316722 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316722 0
Ethics committee country [1] 316722 0
Australia
Date submitted for ethics approval [1] 316722 0
07/10/2024
Approval date [1] 316722 0
18/12/2024
Ethics approval number [1] 316722 0

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

Contacts
Principal investigator
Name 138790 0
Prof Cathie Sherrington
Address 138790 0
Institute for Musculoskeletal Health Level 10N, King George V Building Missenden Road Camperdown NSW 2050
Country 138790 0
Australia
Phone 138790 0
+61 439402651
Fax 138790 0
Email 138790 0
[email protected]
Contact person for public queries
Name 138791 0
Isabella Khoudair
Address 138791 0
RPA Virtual Hospital Level 9, King George V Building Missenden Road Camperdown NSW 2050
Country 138791 0
Australia
Phone 138791 0
+61 401837737
Fax 138791 0
Email 138791 0
[email protected]
Contact person for scientific queries
Name 138792 0
Isabella Khoudair
Address 138792 0
RPA Virtual Hospital Level 9, King George V Building Missenden Road Camperdown NSW 2050
Country 138792 0
Australia
Phone 138792 0
+61 401837737
Fax 138792 0
Email 138792 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:
• To any researcher working in the same or similar field


Conditions for requesting access:
• -

What individual participant data might be shared?
• All de-identified individual participant data collected during the trial


What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
From the time of publication until the 15 years after


To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Ethics approval will be required prior to accessing any of these data. Interested parties will need to request the data from RPA Virtual Hospital's General Manager and the Sydney Local Health District Human Research Ethics Committee (HREC) - RPAH. The RPA Virtual Hospital's General Manager can be contacted via the research office on [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolKhoudair, I. (2025, January 14). Group Run Virtual Physiotherapy (GRIP) Protocol. https://doi.org/10.17605/OSF.IO/2WZJThttps://doi.org/10.17605/OSF.IO/UT76R[email protected] Study Protocol will be made available upon reasona... [More Details]


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.