ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001026314

Ethics application status

Approved

Date submitted

10/02/2026

Date registered

20/08/2026

Date last updated

20/08/2026

Date data sharing statement initially provided

20/08/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluating implementation of the train-the-trainers model to improve access to community-based physical activity for people with spinal cord injury.

Scientific title

Evaluating train-the-trainer model for Spinal Cord Injury (T3-SCI): A Hybrid Type II Implementation-effectiveness Randomised Controlled Trial to Improve Access to Physical Activity for People with Spinal Cord Injury.

Additional trial identifiers [1]

None

Universal Trial Number (UTN)

Trial acronym

T3-SCI

Related trial records

You may access preliminary data demonstrating effectiveness of the T3-SCI program, here:
de Oliveira BI, Howie EK, Dunlop SA, Galea MP, McManus A, Allison GT. SCIPA Com: outcomes from the spinal cord injury and physical activity in the community intervention. Spinal Cord. 2016 Oct;54(10):855-860. DOI: 10.1038/sc.2015.235.
The proposed RCT will build upon this data to conduct a Hybrid Type II randomised controlled trial to confirm T3-SCI effectiveness and implementation into routine practice.

Health condition

Health condition(s) studied:

Spinal Cord Injury

Physical inactivity

Condition category

Condition code

Neurological

Other neurological disorders

Injuries and Accidents

Other injuries and accidents

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

The Train-The-Trainer Spinal Cord Injuries (T3-SCI) intervention is a multi-component program consisting of (1) training of exercise professionals and (2) delivery of an individualised, supervised physical activity program for people with spinal cord injury (SCI). Exercise professionals complete the T3-SCI training program via the Spinal Cord Injuries Australia online platform, incorporating self-directed modules, mentored case-based assessments, and facility safety checks (estimated completion10hrs). The modules cover content designed to improve knowledge of SCI pathophysiology and clinical characteristics, risks associated with physical activity, and how to develop safe and inclusive exercise programming with modifications for people with SCI. Content of the T3-SCI program is delivered through presentations, short videos, case studies, multiple choice assessments, self-directed reading and mentorship with an exercise physiologist or physiotherapist experienced in exercise prescription to people with SCI.
Following training, participants with SCI receive a 12-week, face-to-face exercise program delivered in participant-nominated community fitness centres by T3-SCI–trained exercise professionals. Sessions are delivered individually or in small groups (1–3 participants), twice weekly for 30–60 minutes, and include moderate-vigorous intensity aerobic exercise, progressive resistance training, and flexibility and balance activities consistent with current SCI physical activity guidelines. Exercises might involve use of gym equipment (i.e.: free weights, ergometers, weight machines) and body-weight exercises. Exercise intensity will be determined based on the BORG scale of perceived exertion (RPE). Exercise programs are tailored to individual goals, injury characteristics, physical capacity, and safety considerations, with adaptations made throughout the intervention as required. Programs are reviewed prior to commencement and ongoing remote support is provided to exercise professionals by the research team.

Intervention code [1]

Behaviour

Intervention code [2]

Lifestyle

Description of the comparator or control

Participants randomised to the control group will receive no intervention/usual care during the 12-week intervention period. Usual care consists of continuing with their existing activities and services without access to the T3-SCI program or supervised exercise through the study. Control participants will be offered the opportunity to participate in the T3-SCI program after completion of the final 24-week follow-up assessments.

Control group

Active

Outcomes

Primary outcome [1]

We will measure a composite primary implementation outcome, based on consumer's perceptions of acceptability, appropriateness, adoption, fidelity, feasibility, and sustainability.

Timepoint [1]

We will run approximately 4 focus groups each containing 6 individuals for both people with SCI (total sample=24) and exercise professionals (total sample=24). Our sample is guided by ‘Information Power’, which is typically achieved after 3-4 focus groups with 4-6 people (please see, reference: Materud et al., 2016. Sample size in qualitative interview studies: guided by information power. Qualitative Health research, 26(13): 1753-1760). Focus groups will be scheduled during 12-24 weeks post intervention commencement, based on participant availability.

Primary outcome [2]

Effectiveness of the T3-SCI program at improving physical activity (minutes/week).

Timepoint [2]

For people with SCI, at baseline, 12 weeks, and 24 weeks post-intervention commencement.

Secondary outcome [1]

Cost-effectiveness of the T3-SCI program compared to no intervention.

Timepoint [1]

Health-care utilisation and study-related costs will be collected monthly, from baseline up to 24-months post-commencement of the program.

Secondary outcome [2]

Safety

Timepoint [2]

Audited for people with SCI monthly, from baseline up to 24-months post-commencement of the program.

Secondary outcome [3]

Quality of life

Timepoint [3]

For people with SCI at baseline, 12 weeks and 24 weeks post intervention commencement

Secondary outcome [4]

Self-efficacy

Timepoint [4]

For people with SCI at baseline, 12 weeks and 24 weeks post-commencement of the intervention

Secondary outcome [5]

Personal well-being

Timepoint [5]

For people with SCI at baseline, 12 weeks and 24 weeks post-commencement of the intervention

Secondary outcome [6]

Goal achievement

Timepoint [6]

For people with SCI at baseline, 12 weeks and 24 weeks post-commencement of the intervention

Secondary outcome [7]

Frequency of secondary conditions

Timepoint [7]

For people with SCI at baseline, 12 weeks and 24 weeks post-commencement of the intervention

Eligibility

Key inclusion criteria

People with Spinal Cord Injury (SCI):
1. Adults aged greater than, or equal to, 18 years.
2. Diagnosis of spinal cord injury of any aetiology and time since injury.
3. Self-reported neurological level C5 to S4–5, with ISNCSCI classification A–D, or C1–C4 incomplete where able to actively exercise in the community.
4.Discharged from inpatient rehabilitation.
5. Medically cleared by a GP or physician to participate in physical activity.

Exercise Professionals:
1. Adults aged greater than, or equal to, 18 years.
2. Able to communicate in English.
3. Accredited Exercise Physiologist, Exercise .Scientist, or Registered Personal Trainer.
4. Currently working in a fitness centre for more than 3 months.
5. Completion of the T3-SCI training program.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Yes

Key exclusion criteria

People with Spinal Cord Injury:
Full neurological recovery following SCI
Medical contraindications to participation in exercise in a fitness centre
Self-reported SCI classified as ISNCSCI A–C4
Presence of neurological conditions affecting capacity to participate (e.g. dementia, traumatic brain injury).

Exercise professionals:
No documented evidence of current public liability and professional indemnity insurance.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

With 40 participants per arm (80 in total), we will have >0.8 power to detect a difference in change in physical activity participation from a baseline of 20 minutes per day between study arms (assuming SD=28, from previous study [de Oliveira et al., (2016)] and a drop-out rate of 20%)

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/02/2027

Actual

Date of last participant enrolment

Anticipated

28/02/2029

Actual

Date of last data collection

Anticipated

30/08/2029

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Western Sydney University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Western Sydney Human Research Ethics Committee

Ethics committee address [1]

https://www.westernsydney.edu.au/research/research_ethics_and_integrity/human_ethics/apply_for_human_research_ethics_review

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/01/2026

Approval date [1]

17/06/2026

Ethics approval number [1]

H17176

Summary

Brief summary

People with spinal cord injury (SCI) often face barriers to being physically active in the community, which can negatively affect their health and quality of life. This study aims to test a program called T3-SCI (Train the Trainers – Spinal Cord Injury), which trains exercise professionals to safely and confidently support people with SCI to exercise in local gyms. The main purpose of this study is to find out whether the T3-SCI program can be delivered effectively in real-world community fitness centres and whether it helps people with SCI become more physically active compared with usual care. We hypothesise that people with SCI who take part in the T3-SCI program will increase their physical activity levels and experience better health and well-being outcomes than those who do not receive the program, and that the program will be acceptable, feasible, and delivered with good quality by trained exercise professionals.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Camila Quel de Oliveira

Address

Western Sydney University, Locked bag 1797, Penrith NSW, Australia 2751

Country

Australia

Phone

+61246203851

Fax

[email protected]

Contact person for public queries

Name

Cassandra Thompson

Address

Western Sydney University, Locked bag 1797, Penrith NSW, Australia 2751

Country

Australia

Phone

+612 4620 3803

Fax

[email protected]

Contact person for scientific queries

Name

Cassandra Thompson

Address

Western Sydney University, Locked bag 1797, Penrith NSW, Australia 2751

Country

Australia

Phone

+612 4620 3803

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically