Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000734460
Ethics application status
Approved
Date submitted
18/06/2025
Date registered
10/07/2025
Date last updated
10/07/2025
Date data sharing statement initially provided
10/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
EngAGE Community: A Student-led Telehealth Exercise Strategy Aiming to Improve Social, Psychological and Physical Wellbeing of Older Adults
Scientific title
EngAGE Community: A Student-led Telehealth Exercise Strategy Aiming to Improve Social, Psychological and Physical Wellbeing of Older Adults
Secondary ID [1] 314594 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ageing 337715 0
Loneliness 337716 0
Condition category
Condition code
Public Health 334045 334045 0 0
Health service research
Public Health 334062 334062 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EngAGE Community is a 15-week group-based telehealth program delivered by Zoom (Version 6.0.4) which utilises a student-led delivery model. 3-5 student practitioners will be allocated to each program, supervised by an Accredited Exercise Physiologist (AEP). Each program is delivered on a single day each week for a 15-week period and consists of two key phases: a 3-week preparation phase and a 12-week program delivery phase.
Preparation phase
During the 3-week preparation phase, the AEP facilitates a 20minute Zoom pre-exercise health screening with each participant using the Adult Pre-exercise Screening System (APSS). The APSS is a standardized questionnaire that be used to identify individuals who may be at risk of experiencing health issues during exercise and assists to determine what level a person can safely begin an exercise program or if they need medical clearance first. During this phase, student practitioners complete a structured and supervised 12-hour training program (3 weeks x 4 hours) with an Accredited Exercise Physiologist via Zoom to familiarise them with the EngAGE framework and prepare for the individual needs of the older adult participants. Students must attend the virtual training which also covers topics such as communicating effectively with older people, telehealth best practice, primary healthcare systems, program assessment and delivery components, and consultative time with AEPs for specific program design.
Program delivery phase
The 12-week program delivery phase consists of three 4-week modules. The modules conceptually progress participants through initiating new social networks and learning new exercise skills, towards solidifying social networks and applying new exercise skills independently. During this 12-week phase, weekly 2-hour EngAGE classes consist of exercise, sharing, creative, and educational activities designed to be fun, socially engaging, and build a sense of community. These activities are performed either as a whole group (whole program rotation ~20-25 older adults & 4-5 student practitioners & supervising AEP) or in small groups (4-5 older adults & 1 student practitioner) as required using breakout rooms to maximise engagement based on the specific activity.
Exercise activities are always completed in small groups and consist of whole-body exercises that target mobility, strength, and balance with the complexity and intensity of the exercises being tailored to the individual needs of each participant and progressing over the program. General recommendations for program design are completing flexibility and mobility work that targets the whole body with a minimum of 1 set per body region (i.e. Cervical, thoracic, lumbar/hip, lower limb, shoulder) and 2-3 sets of 8-12 repetitions of strength and balance targeting the whole body. The individualisation of the exercise program will be initially based on the outcomes from the pre-exercise health screening, mainly the participants starting physical activity levels, any participant goals, and health concerns or limitations. Participants will be grouped into their small groups with other participants of similar physical capacity and social interests as decided by the Accredited Exercise Physiologist in consultation with the Student Practitioners. As such, participants in each small group can be prescribed similar exercise activities which can be progressed or regressed each week based on participant presentation and progression each week. This individualisation is preferred as there is diverse presentation of participants at the start of the program, and there is no one size fits all exercise prescription. Sharing activities generally look to build and strengthen social bonds between participants and can include ice breaker games, sharing of personal items such as photo albums, cookbooks, health goals etc. Creative activities are developed to be a group shared experience with examples being drawing/painting, collage, virtual museum tours etc. Education activities are a series of prescribed presentations about specific health aspects relevant to older adults and non-prescribed presentations that are developed based on the common interests of the group. Student practitioners lead their group activities each week with supervisory guidance from the AEP. Student practitioners and the supervising AEP mark attendance of older adult participants each session. Student practitioners are also provided 1 hour of guided preparation and reflection on either side of the 2-hour class to ensure program quality and student progression.
Intervention code [1] 331231 0
Lifestyle
Intervention code [2] 331232 0
Behaviour
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341723 0
Social Health and loneliness - This will be assessed as a composite primary outcome
Timepoint [1] 341723 0
All completed at baseline and immediately following the final session of the 12-week program delivery phase
Secondary outcome [1] 448535 0
Psychological Health and Quality of Life - This will be assessed as a composite outcome
Timepoint [1] 448535 0
All completed at baseline and immediately following the final session of the 12-week program delivery phase
Secondary outcome [2] 448846 0
Physical Health - This will be assessed as a composite outcome
Timepoint [2] 448846 0
SEE and BREQ2 are completed at baseline and immediately following the final session of the 12-week program delivery phase Sit to Stand Test, Wall Push Up Test and Single Leg Balance Test completed at baseline, in the weekly session during week 6 of program and during the final session of the program
Secondary outcome [3] 448849 0
Student Self Efficacy and Work Readiness - This will be assessed as a composite outcome
Timepoint [3] 448849 0
All completed at baseline and immediately following the final session of the 12-week program delivery phase

Eligibility
Key inclusion criteria
Older Adult Participants:
1. 65 years of age and over
2. Living in the community (not in a Residential Aged Care Facility)
3. Living in the NSW Central Coast or Hunter New England Regions
4. Have access to the internet and a device that has zoom capabilities

Student Participants:
1. A Student enrolled in an Exercise Science or Exercise Physiology program in Australia
2. Meet the course practicum requirements to do external practicum
3. Able to complete the pre-program training (~12 hours)
4. Able to complete the surveys
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No additional exclusion criteria for applicants who meet inclusion criteria

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Average responses to survey questions will be calculated as well as standard deviation as a measure of the spread of the data. Statistical comparisons will be made across time to assess changes in survey responses across the program. Qualitative responses for program enjoyment and feedback will be analysed for thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/01/2022
Date of last participant enrolment
Anticipated
27/02/2026
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
150
Accrual to date
130
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319141 0
Government body
Name [1] 319141 0
Hunter New England and Central Coast Primary Health Network
Country [1] 319141 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 321607 0
University
Name [1] 321607 0
The University of New South Wales
Address [1] 321607 0
Country [1] 321607 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317734 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 317734 0
Ethics committee country [1] 317734 0
Australia
Date submitted for ethics approval [1] 317734 0
08/09/2021
Approval date [1] 317734 0
15/12/2021
Ethics approval number [1] 317734 0
H-2021-0300

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

Contacts
Principal investigator
Name 141974 0
Prof Frederick Rohan Walker
Address 141974 0
University of Newcastle, Room 306, Medical Sciences Building, University Drive, Callaghan, NSW, 2308, Australia
Country 141974 0
Australia
Phone 141974 0
+61 2 4921 5012
Fax 141974 0
Email 141974 0
[email protected]
Contact person for public queries
Name 141975 0
Dr Nattai Borges
Address 141975 0
UNSW, School of Health Sciences, Faculty of Medicine & Health, Wallace Wurth Building, Sydney NSW 2052
Country 141975 0
Australia
Phone 141975 0
+61 2 9348 1150
Fax 141975 0
Email 141975 0
[email protected]
Contact person for scientific queries
Name 141976 0
Dr Nattai Borges
Address 141976 0
UNSW, School of Health Sciences, Faculty of Medicine & Health, Wallace Wurth Building, Sydney NSW 2052
Country 141976 0
Australia
Phone 141976 0
+61 2 9348 1150
Fax 141976 0
Email 141976 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:
• Anyone
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
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
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: [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.