Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001093370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
19/08/2026
Date registered
Help: Date registered
4/09/2026
Date last updated
Help: Date last updated
4/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
4/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Comparing the effects of two gym-based exercise programs on balance in adults aged 40 to 64 years
Scientific title
Machine-based strength training versus multi-planar functional training for force plate measured single-leg balance in community-dwelling adults aged 40 to 64 years: a parallel-group randomised controlled trial
Additional trial identifiers [1] 318094 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Fall prevention 343129 0
Age-related balance decline 343130 0
Condition category
Condition code
Public Health 339212 339212 0 0
Health promotion/education
Public Health 339213 339213 0 0
Other public health
Physical Medicine / Rehabilitation 339484 339484 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1: Multi-planar functional training

Participants allocated to the multi-planar functional training group will complete a 12-week gym-based functional exercise program. The program will use mostly standing exercises performed with free weights, kettlebells, resistance bands, cable machines, steps, and balance equipment. Exercises will emphasise multi-joint movements across different directions and planes of motion, including stepping, lunging, reaching, rotating, carrying, and single-leg control tasks. Example exercises include reverse lunge to row, step-up with cable push, single-leg Romanian deadlift to overhead press, lateral lunge with rotation, and multi-directional reaches.

The program will be delivered face to face in a semi-supervised format during staffed facility hours. Participants will complete sessions individually, with supervision and support available from HSCfit exercise staff and University of Newcastle exercise science and exercise physiology students. The Principal Researcher, an Accredited Exercise Physiologist, will oversee intervention delivery and program progression.

Participants will attend two sessions per week for 12 weeks. Each session will be scheduled for approximately 60 minutes. Participants will complete approximately 2 to 3 sets of 8 to 12 repetitions or 60 to 90 seconds per exercise at a target rating of perceived exertion of 5 to 8. Exercises will be progressed or regressed individually according to tolerance, technique, movement competency, and perceived effort.

The intervention will be delivered at HSCfit, Hunter Sports Centre, Glendale, New South Wales, Australia.

Adherence will be monitored using attendance records, participant program cards, and session records. Program cards will document prescribed exercises, completion, progressions, modifications, and rating of perceived exertion. Missed sessions may be made up within the same training week where possible. Adverse events will be recorded using study session records and reviewed by the Principal Researcher.
Intervention code [1] 334976 0
Prevention
Intervention code [2] 334977 0
Lifestyle
Description of the comparator or control
The comparator is machine-based strength training. Participants allocated to this group will complete a 12-week gym-based resistance training program using pin-loaded and plate-loaded resistance machines. The program will emphasise stable, mostly bilateral strengthening exercises performed in seated or supported positions, with machines providing external support and guiding movement through a fixed range of motion. Example exercises include leg press, chest press, seated row, leg extension, and leg curl.

The comparator will be delivered face to face in a semi-supervised format during staffed facility hours. Participants will complete sessions individually, with supervision and support available from HSCfit exercise staff and University of Newcastle exercise science and exercise physiology students. The Principal Researcher, an Accredited Exercise Physiologist, will oversee the comparator program, including exercise prescription, monitoring, and progression.

Participants will attend two sessions per week for 12 weeks. Each session will be scheduled for approximately 60 minutes. Participants will complete approximately 2 to 3 sets of 8 to 12 repetitions at a target rating of perceived exertion of 5 to 8. Exercises will be progressed or regressed individually according to participant tolerance, technique, and perceived effort.

The comparator will be delivered at HSCfit, Hunter Sports Centre, Glendale, New South Wales, Australia.

Adherence will be monitored using attendance records, participant program cards, and session records. Program cards will document prescribed exercises, completion, progressions, modifications, and rating of perceived exertion. Missed sessions may be made up within the same training week where possible. Adverse events will be recorded using study session records and reviewed by the Principal Researcher.
Control group
Active

Outcomes
Primary outcome [1] 346457 0
Balance performance
Timepoint [1] 346457 0
Baseline, and 6, 12, and 24 weeks post-baseline. Primary comparison: baseline to 12 weeks post-baseline.
Secondary outcome [1] 465885 0
Lower limb muscle strength and power - this will be assessed as a composite outcome
Timepoint [1] 465885 0
Baseline, and 6, 12, and 24 weeks post-baseline.

Eligibility
Key inclusion criteria
Community-dwelling, functionally independent adults aged 40 to 64 years who are able to read and understand English, provide informed consent, and safely participate in moderate-intensity exercise. Participants must have no structured exercise history or currently complete three or fewer structured exercise sessions per week.

Structured exercise includes gym-based exercise, resistance training, functional training, HIIT, circuit classes, Pilates, yoga, personal training with a strength or balance component, and organised sport training. Incidental or recreational physical activity such as walking, recreational cycling, swimming, or running does not count towards the structured exercise threshold unless undertaken as part of a structured training program.

Participants must also be classified as Tier 0 (sedentary), Tier 1 (recreationally active), or Tier 2 (trained/developmental) according to the Participant Classification Framework.
Minimum age
40 Years
Maximum age
64 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants will be excluded if they are currently completing more than three structured exercise sessions per week; classified as Tier 3 (highly trained/national level), Tier 4 (elite/international level), or Tier 5 (world-class athlete) according to the Participant Classification Framework (McKay et al., 2022); have a neurological condition affecting balance or movement, such as stroke, Parkinson’s disease, or multiple sclerosis; have a current vestibular or inner ear condition affecting balance; have a significant musculoskeletal limitation that prevents safe participation; have had surgery or significant injury within the past six months affecting exercise capacity; have an uncontrolled cardiovascular or medical condition; have cognitive impairment affecting ability to participate; are currently receiving physiotherapy for a balance or walking condition; are currently enrolled in a structured balance training or falls prevention program; have participated in another exercise intervention research study within the past three months; or have a planned absence that would prevent completion of the 12-week program.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be enrolled and complete baseline assessment before randomisation. Allocation will be concealed until all baseline assessments have been completed. Randomisation will be triggered by the Principal Researcher using the REDCap Randomisation Module after eligibility has been confirmed and baseline data collection is complete. Group allocation will then be communicated to HSCfit operational staff for scheduling and intervention delivery purposes only.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be computer-generated using the REDCap Randomisation Module. Participants will be allocated in a 1:1 ratio to multi-planar functional training or machine-based strength training. Stratified block randomisation will be used, with variable block sizes of 4 or 6. Stratification factors will be sex recorded at birth.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The recruitment target is 80 participants, with 40 participants per group. The required sample size was estimated as 68 participants, with 34 per group, based on the primary balance outcome using single-leg centre of pressure reliability data from Collings et al. (2024). The calculation assumed an effect size of Cohen’s d 0.8, 80% power, alpha 0.05 using a two-tailed test, and allowed for approximately 20% attrition. The primary analysis will compare between-group change in balance performance from baseline to 12 weeks using mixed-effects linear regression, with participant included as a random effect to account for repeated measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2026
Actual
Date of last participant enrolment
Anticipated
17/09/2027
Actual
Date of last data collection
Anticipated
17/12/2027
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322652 0
University
Name [1] 322652 0
College of Health, Medicine and Wellbeing, The University of Newcastle
Country [1] 322652 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 325578 0
Commercial sector/Industry
Name [1] 325578 0
Hunter Sports Centre / HSCfit
Address [1] 325578 0
Country [1] 325578 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321111 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 321111 0
Ethics committee country [1] 321111 0
Australia
Date submitted for ethics approval [1] 321111 0
01/07/2026
Approval date [1] 321111 0
28/08/2026
Ethics approval number [1] 321111 0
H-2026-0126

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

Contacts
Principal investigator
Name 152702 0
Mr Matthew Kolasinski
Address 152702 0
The University of Newcastle University Drive, Callaghan NSW 2308
Country 152702 0
Australia
Phone 152702 0
+61 401872184
Fax 152702 0
Email 152702 0
[email protected]
Contact person for public queries
Name 152703 0
Matthew Kolasinski
Address 152703 0
The University of Newcastle University Drive, Callaghan NSW 2308
Country 152703 0
Australia
Phone 152703 0
+61 401872184
Fax 152703 0
Email 152703 0
[email protected]
Contact person for scientific queries
Name 152704 0
Matthew Kolasinski
Address 152704 0
The University of Newcastle University Drive, Callaghan NSW 2308
Country 152704 0
Australia
Phone 152704 0
+61 401872184
Fax 152704 0
Email 152704 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 a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies testing whether findings can be repeated or confirmed
• Scientific scrutiny or related research approved by the research team and consistent with participant consent, ethics approval, and University of Newcastle research data management policy.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Requests should be directed to the trial custodian using the institutional email address listed for the study contact.
Matthew Kolasinski: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Only de-identified data may be shared. Shared data will exclude names, contact details, dates of birth, consent forms, screening records, linkage keys, audio recordings, interview recordings, and any information that could reasonably identify individual participants. Requests will be assessed for consistency with participant consent, ethics approval, privacy requirements, and University of Newcastle research data management policy.



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.