Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000829415p
Ethics application status
Not yet submitted
Date submitted
16/07/2025
Date registered
1/08/2025
Date last updated
1/08/2025
Date data sharing statement initially provided
1/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of an All-Abilities Gym Program for Young Adults with physical disabilities.
Scientific title
Feasibility of a student-mentored gym-based intervention for Young Adults with non-progressive disabilities in regional centre.
Secondary ID [1] 314921 0
Nil known
Universal Trial Number (UTN)
U1111-1325-4133
Trial acronym
Linked study record
Current study is a follow up of ACTRN12623001293651.
The PI is commencing this work at a new organisation, and with a wider participant pool and locale (Warrnambool, VIC and Cairns, QLD).

Health condition
Health condition(s) or problem(s) studied:
Physical disability 338242 0
Condition category
Condition code
Neurological 334520 334520 0 0
Other neurological disorders
Musculoskeletal 334521 334521 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12-week intervention program is designed for young adults aged 18 to 40 with a personal with a physical disability (PwD) and reside in regional areas. The intervention involves a screening process using the PAR-Q+ questionnaire to assess the participant's readiness for exercise. Medical clearance is sought if indicated by the screening results. Upon clearance, participants will be paired with student peer mentors studying a heatlh related degree at a regional University Campus in Warrnambool, Victoria or Cairns, Queensland. These mentors will not be functioning as personal trainers or health specialists will exercise alongside the PwD, following a tailored exercise regime created by a physiotherapist.

The intervention consists of two 1-hour sessions per week for 12 weeks, incorporating progressive resistance and aerobic exercises. Intensity will be prescribed at a moderate intensity, and assessed using RPE for cardiovascular exercise and repetition range of 10 to 12 repetitions for progressive strength training. Exercise sessions will be monitored via PhysiTrack, an online exercise prescription, delivery and monitoring tool. Exercises may consist of an arm ergometer for upper limb cardiovascular training and pin loaded machines, bands and cables for progressive strength training, aiming for a repetition range of 10 - 12. Before participation, mentors undergo 2 hours of online disability awareness training and one hour in person training, covering program content, manual handling, and strategies to motivate and support PwD. Participants also meet with the principal investigator (PI) for customisation of exercise prescriptions aligned with their goals, preferences, and abilities. Safety instructions on equipment use will be provided in the first week, with the PI supervising the initial two gym sessions and conducting weekly check-ins with each exercising pair separately.

The intervention will operate within a local council community gym, screened prior for access and safety, Participants will receive a gym membership for the 12-week duration and undergo interviews using semi-structured schedules at the program's conclusion. Outcome measures include validated tools assessing participation, quality of life, and physical fitness data collected and analysed from program logs. Gym staff (2), will also be interviewed after the intervention for their perspectives on the trial.
Intervention code [1] 331526 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342200 0
Primary - Feasibility - Safety / Practicality, which will be assessed as a composite of primary outcome.
Timepoint [1] 342200 0
Safety data collected throughout 12-weeks of intervention Data is collected in 'real-time' by the participant (student mentor) at the time of incident. Data is checked bi-weekly by the PI, or once contacted if in the case of an incident.
Primary outcome [2] 342201 0
Primary - Feasibility - Acceptability
Timepoint [2] 342201 0
Interviews will be completed 1-week post-intervention (12-weeks + 1-week).
Primary outcome [3] 342202 0
Primary - Feasibility - Adaption
Timepoint [3] 342202 0
Adaptation log data will be collected throughout 12-weeks of intervention. Interviews will be completed 1-week post-intervention (12-weeks + 1-week). Data is collected in 'real-time' by the participant (student mentor) at the time of the adaptation being noted as required. Data is checked bi-weekly by the PI, or once contacted if in the case of an adapation requirement which is impacting the intervention..
Secondary outcome [1] 449953 0
Limited-efficacy Participation
Timepoint [1] 449953 0
Both outcome measures GAS and Y- PEM will be assessed at 0, 6, 12-weeks and follow-up at 24-weeks.
Secondary outcome [2] 449954 0
Limited-efficacy Quality of Life.
Timepoint [2] 449954 0
Quality of Life - PROMIS Scale will be assessed at 0, 6, 12-weeks and follow-up at 24-weeks.

Eligibility
Key inclusion criteria
Group 1: Persons with Physical Disability
• Aged between 18 and 40 years.
• Has a non-progressive physical disability.
• Can follow simple instructions delivered through their preferred method of communication (e.g., verbal, written, or gestured).
• Able to provide their own consent (in written, spoken, or gestured form).
• Able to participate in a moderate-to-high intensity exercise program as determined by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) (15). If clearance is indicated by the screening tool, the participant must obtain approval from a general practitioner at their own expense.

Group 2: Student Peer Mentor
1. University student - any year level – from Deakin University School of Nursing, Occupational Therapy or Health Science.
2. Hold current police checks, or willing to obtain prior to commencement of study.
3. Not explicit inclusion criteria but preference for similar age and interests to adult with CP.

Group 3: Gym Staff
• Member of participating gym, who participated in CQU Disability & Health Micro-credentialing Training and assisted with the all-abilities gym program.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Group 1: Persons with Physical Disability
1. Have participated in a gym-based program within the past three months.
2. Have an unstable, or acute medical condition and have been deemed unsafe to participate by their doctor or health professional (i.e., epilepsy, cardiac condition).
3. Neurological conditions which are degenerative (i.e., muscular dystrophy).
4. A significant psychological or behavioural disorder that would impact their participation (e.g., resistive behaviour, severe depression, or severe anxiety) as reported by the participant or observed during recruitment and project onboarding.

Study design
Purpose of the study
Treatment
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
There are several key components to the analysis of the data. As a first step, demographic data (age, gender, health, description of disability and associated impairments) will be described at the case level ensuring that no participant will be able to be identified.
Quantitative data will be collected and discussed at the individual level using descriptive statistics.
The qualitative data collected from interviews will be analysed using a qualitative description methodology.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 319483 0
University
Name [1] 319483 0
CQUniversity: Appleton Institute - Physical Activity Research Group
Country [1] 319483 0
Australia
Primary sponsor type
University
Name
CQUniversity: Appleton Institute
Address
Country
Australia
Secondary sponsor category [1] 321971 0
None
Name [1] 321971 0
Address [1] 321971 0
Country [1] 321971 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 318055 0
CQ University's Human Research Ethics Committee
Ethics committee address [1] 318055 0
Ethics committee country [1] 318055 0
Australia
Date submitted for ethics approval [1] 318055 0
18/08/2025
Approval date [1] 318055 0
Ethics approval number [1] 318055 0

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

Contacts
Principal investigator
Name 142978 0
Mr James Czencz
Address 142978 0
Central Queensland University, 42-52 Abbott Street & Shields Street, Cairns, QLD 4870
Country 142978 0
Australia
Phone 142978 0
+61740374732
Fax 142978 0
Email 142978 0
[email protected]
Contact person for public queries
Name 142979 0
James Czencz
Address 142979 0
Central Queensland University, 42-52 Abbott Street & Shields Street, Cairns, QLD 4870
Country 142979 0
Australia
Phone 142979 0
+61749230000
Fax 142979 0
Email 142979 0
[email protected]
Contact person for scientific queries
Name 142980 0
James Czencz
Address 142980 0
Central Queensland University, 42-52 Abbott Street & Shields Street, Cairns, QLD 4870
Country 142980 0
Australia
Phone 142980 0
+61749230000
Fax 142980 0
Email 142980 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Not applicable for feasibility study, or interview data to protect participant identity.



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.