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Trial registered on ANZCTR


Registration number
ACTRN12625000351415
Ethics application status
Approved
Date submitted
8/04/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A therapeutic movement program for adolescents engaged in gender diversity services
Scientific title
The Movement Program: Feasibility of a trans-specific exercise program for adolescent clients at gender diversity services
Secondary ID [1] 314167 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 337007 0
neurodivergence 337008 0
gender dysphoria 337009 0
sedentary behaviour 337010 0
well-being 337011 0
quality of life 337012 0
eating disorders 337013 0
disordered eating 337118 0
Condition category
Condition code
Physical Medicine / Rehabilitation 333465 333465 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- The "Movement Program" is a twelve-week exercise intervention for adolescents within the GENder identiTy Longitudinal Experience Cohort (GENTLE cohort; RGS0000000320).

- Frequency and mode of administration: one supervised group exercise session per week for 12 consecutive weeks. Groups of minimum 3, maximum 10 participants.

- Intensity: The program's activities are designed to be adaptable, with exercises that can be progressed and/or regressed to suit varying age groups and abilities, ensuring all participants are both engaged and appropriately challenged. Progression may include increased duration of activity, greater resistance, or more complex movements. Session intensity will be assessed via a Borg RPE at the end of each session. Overall session intensity will range from moderate to vigorous depending on participant presentations.

- Time: Each session will run for 60 minutes.

- Type of exercises prescribed: Each exercise session will include a variety of elements, described below, and can be tailored for individual differences, needs and abilities. A warm-up and check-in will be undertaken (e.g., adequate nutritional intake, any new injuries, mood check in) to prepare the participants for physical activity and allow for exercise modifications or limitations. Followed by cardiorespiratory fitness activities that elevate heart and breathing rates (e.g., running, dancing, or aerobic fitness games); muscular strength exercises targeting strength and endurance of various muscle groups, using free weight equipment or bodyweight (e.g., push-ups, squats, planks); sport skill development or games to assist team building and socialisation (e.g., soccer, pickleball, or floorball).

- Strategies to monitor adherence: session attendance checklists are completed at the end of each session by the exercise instructor in their clinical handover notes. Reason for absenteeism are also written down in the session checklist.

- Elements specifically tailored to trans adolescents include: The movement program will be held at local community recreational spaces, including indoor (e.g., halls) and outdoor spaces (e.g., ovals). These venues will be carefully set up to prioritise the safety and inclusive environment for trans adolescents. For example, creating a safe and inclusive space may include removing or covering mirrors, displaying LGBTQIA+ affirming signage, providing all-gender bathroom access, and offering orientation and inductions to help participants feel comfortable, familiarised and supported in the space.
Intervention code [1] 330765 0
Rehabilitation
Intervention code [2] 330766 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341039 0
Feasibility - This will be assessed as a composite outcome
Timepoint [1] 341039 0
Study level outcome (e.g., recruitment, reach, adherence) measures will be assessed upon conclusion of the study. For participant-level outcomes (e.g., intervention satisfaction, enjoyment, motivation) measures will be assessed at completion of the 12-week exercise program.
Secondary outcome [1] 445913 0
Physical Activity Participation Levels
Timepoint [1] 445913 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [2] 445914 0
Quality of Life.
Timepoint [2] 445914 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [3] 445915 0
Well-Being
Timepoint [3] 445915 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [4] 445916 0
Flexibility
Timepoint [4] 445916 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [5] 445917 0
Power
Timepoint [5] 445917 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [6] 445918 0
Balance
Timepoint [6] 445918 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [7] 445919 0
Cardiorespiratory Fitness
Timepoint [7] 445919 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [8] 445920 0
Strength.
Timepoint [8] 445920 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [9] 445921 0
Body Composition
Timepoint [9] 445921 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [10] 446341 0
Cardiovascular health
Timepoint [10] 446341 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [11] 446342 0
Muscular endurance strength
Timepoint [11] 446342 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [12] 446343 0
Muscular endurance strength
Timepoint [12] 446343 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
Secondary outcome [13] 446344 0
Muscular endurance strength
Timepoint [13] 446344 0
Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.

Eligibility
Key inclusion criteria
All intervention participants will be current patients who are engaged with the Child and Adolescent Health Service, Perth Children’s Hospital Gender Diversity Service and who have consented to be part of the GENTLE Cohort (Children and Adolescent Health Service Health Research Ethics Committee RGS0000000320).

Intervention participants must have a sufficient command of the English language to be able to consent/assent or have parent/carer consent to participation.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are unable to safely participate in exercise based on pre-exercise screening (ESSA., 2022).

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
Efficacy
Statistical methods / analysis
All quantitative data will be analysed using Microsoft Excel and IBM Statistical Package for the Social Sciences (SPSS) Statistics software. Descriptive statistics and Repeated Measures Analyses of Variance (ANOVAs) of pre-to-post-program differences will be conducted. The magnitude of change in health outcome variables (i.e., physical health, well-being, and quality of life) from baseline to the end of the program will be determined by calculating Cohen’s d effect sizes, along with correlations between the variables. It is noted that the sample size for this study is in keeping with a pilot study however, given the novelty and intent of the intervention, findings will provide valuable insight into the health outcomes, the most effective operation of the program, and inform design of future interventions and research in this field.

Interviews will be conducted by the research team, who have experience in qualitative research methodology, including interviewing vulnerable young people, families, and health professionals. Participants will guide the interview, with probing questions used for clarification and exploration (Galetta., 2012). At the end, participants can ask questions, offer additional information, and provide feedback. Pragmatic considerations (e.g., time and resource constraints) will guide data collection, and we aim to collect sufficient, appropriate information to address our research questions and construct a comprehensive story through our data. We will adopt an inductive reflexive thematic analysis approach (Braun & Clarke, 2022; Braun et al., 2016). A ‘critical friends’ approach will be employed, with co-authors providing feedback on meaning units, themes, and interpretations (Carlson., 2018). Collaborative processes may result in themes being merged, redefined, or recoded based on collective interpretation, ensuring rigor and quality in analysis (Smith & McGannon., 2018). Reflexive thematic analysis is a cyclical and iterative process (i.e., it is not sequential), and various stages of the analysis process will be repeated or returned to.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/02/2025
Date of last participant enrolment
Anticipated
2/06/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
20
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27732 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 43921 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 318679 0
Charities/Societies/Foundations
Name [1] 318679 0
Thriving in Motion
Country [1] 318679 0
Australia
Funding source category [2] 318680 0
University
Name [2] 318680 0
The University of Western Australia
Country [2] 318680 0
Australia
Funding source category [3] 318681 0
Government body
Name [3] 318681 0
Department of Health and Aged Care - Medical Research Futures Fund
Country [3] 318681 0
Australia
Funding source category [4] 318682 0
Hospital
Name [4] 318682 0
Perth Children's Hospital
Country [4] 318682 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 321104 0
None
Name [1] 321104 0
Address [1] 321104 0
Country [1] 321104 0
Other collaborator category [1] 283468 0
Other
Name [1] 283468 0
The Kids Research Institute Australia
Address [1] 283468 0
Country [1] 283468 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317291 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 317291 0
Ethics committee country [1] 317291 0
Australia
Date submitted for ethics approval [1] 317291 0
16/05/2024
Approval date [1] 317291 0
05/07/2024
Ethics approval number [1] 317291 0
RGS0000006883
Ethics committee name [2] 317293 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [2] 317293 0
Ethics committee country [2] 317293 0
Australia
Date submitted for ethics approval [2] 317293 0
01/08/2024
Approval date [2] 317293 0
06/09/2024
Ethics approval number [2] 317293 0
2024/ET000882

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

Contacts
Principal investigator
Name 140590 0
Mrs Felicity Austin
Address 140590 0
The University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
Country 140590 0
Australia
Phone 140590 0
+61 0400198166
Fax 140590 0
Email 140590 0
[email protected]
Contact person for public queries
Name 140591 0
Felicity Austin
Address 140591 0
The University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
Country 140591 0
Australia
Phone 140591 0
+61 0400198166
Fax 140591 0
Email 140591 0
[email protected]
Contact person for scientific queries
Name 140592 0
Felicity Austin
Address 140592 0
The University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
Country 140592 0
Australia
Phone 140592 0
+61 0400198166
Fax 140592 0
Email 140592 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24620Informed consent form    Movement Program Participant PICF Version 2 24 June 2024.pdf



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.