Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000343404
Ethics application status
Approved
Date submitted
28/01/2025
Date registered
23/04/2025
Date last updated
6/07/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the short and long-term changes experienced by people with physical impairments who undertake supervised sports training
Scientific title
Evaluating the effects of performance-focused sport training on individuals with neuromusculoskeletal impairments: a single-case experiemental design study with longitudinal follow-up
Secondary ID [1] 313559 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuromusculoskeletal Impairments 336065 0
Cerebral Palsy (CP) 337113 0
Spinal Cord Injury (SCI) 337114 0
Acquired Brain Injury (ABI) 337116 0
Condition category
Condition code
Musculoskeletal 332616 332616 0 0
Other muscular and skeletal disorders
Neurological 332617 332617 0 0
Multiple sclerosis
Neurological 332618 332618 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention each participant will be receving is performance-focused sports training through the ParaSTART (service) program at The University of Queensland and delivered by accredited exercise physiologists or physiotherapists who are part of the ParaSTART service and research team. This study will follow a single-case experimental design (SCED) methodology meaning there will be two 16-week periods where the participants will receive the intervention, with shorter periods (5-weeks) of rest in following each intervention phase where the intervention is withdrawn. Below is an outline of the two components which make up the performance-focused sports training intervention.

• Sports-Specific Training: Participants engage in land-based (indoor or outdoor) or aquatic sports aligned with their individual physical capabilities and interests. Training focuses on performance determinants such as speed, endurance, and strength and may include activities such as swimming, wheelchair racing, cycling, and seated throwing.
• Strength and Conditioning: Gym-based strength training is prescribed to improve sport-specific performance and enhance physical capabilities. Multiple exercise modalities will be utilised to train strength, fitness, balance, coordination, proprioception, hypertrophy and fine/gross motor planning and execution. Examples of strength and conditioning exercises which might be prescribed to the participant during the intervention include chest fly, overhead press, seated row, lat pulldown, lateral raises, tricep pushdown, bicep curls, rotational throws, medicine ball throws, palloff press amongst others. Each of these exercises also have the capacity to be modified to increase difficulty or place emphasis differently depending on the needs of each participant.

During each 16-week intervention period of the SCED, participants will be asked to complete 2 x 60-90 minute sport specific training sessions and 1 x 60 minute gym-based training session. It will be intended that the training components of each session will be completed at an intensity of 7-9/10 rating of perceived exertion (RPE), however this can and will be modified depending on day to day presentation of a participant. These sessions will be delivered either individually or in a group with other participants, depending on participant preferences, availability or what is planned for the session. It is intended that all sessions will be completed face-to-face on The University of Queensland St Lucia campus and all required euipment and facilities (e.g. pool, gym/gym equipment, athletics track, sporting equipment) is located and exists within The University of Queensland.

Due to the nature of the population being investigated (individuals with neuromusculoskeletal high support needs impairments) there is a high incidence and severity of comorbidities (e.g. intellectual impairment, seizure disorders etc) leading to heterogeneity among participants. As an example, participants may be primarily diagnosed with the same impairment and severity (e.g. spastic quadriplegia, gross motor function classification system 4) but be extremely different on clinical presentation, therefore needing the intervention entirely individualised to their capacities and abilities. A second layer of this is the different sports each participant may choose to participate in. Each sport will have its own specific needs and requirements to improve performance and therefore interventions will be different across participants involved in different sports.

When the participant begins, there will be a familirisation period where they can sample sports and various exercises/movements. Accredited exercise physiologists or physiotherpaists, in conjunction with the participant, will then determine from observing how they move and what sport they want to participate in to determine what exercise modality is most appropriate for the participant to ensure they are training to the best of their ability and achieving increased performance, which is the intent of performance-focused sports training. After each training session the prescribed session will be reassessed and modifcations will be made to clinically progress/regress the sessions depending on factors such as participant fatigue, how well they handled the exercises and what they need to work towards skill/technique wise in their sport. This will follow the principles of progressive overload in exercise to ensure continued and steady progression is being made.

Intervention adherence will be monitored as a single case experimental design relies upon consistent intervention adherence to ensure a complete data set it achieved and can therefore be used to infer that the changes observed are due to the intervention. It will be initially advertised to participants that they are expeicted to attend at least 80% of their prescribed sessions. This adherence rate will be noted by the accredited exercise physiologists and physioltherapists delivering the intervention.

Intervention code [1] 330151 0
Lifestyle
Intervention code [2] 330313 0
Treatment: Other
Comparator / control treatment
This study will utilise a concurrent, multiple baseline design (MBD) Single-Case Experimental Design (SCED) methodology, therefore no control group will be required as each participant will act as their own control. The defining feature of this methodological design is that participants will be repeatedly measured in various outcome variables during multiple phases. These phases will follow an alternating ABABA structure in which 'A;' phases denote a baseline/withdrawal period where participants will not receive the intervention, and 'B' phases representing periods where the intervention is present. All participant's will be assigned a randomised baseline length which will be individualised to them. Each participant will be asigned one of the following baseline lengths (in weeks) at random: 5, 7, 9, 11.

During each baseline period, participants will be asked to continue their usual lifestyle routines, including their usual levels of physical activity, but not partake in any performance-focused sports training. During this time, participants will be attending regular testing sessions (twice per week) to gather baseline data for each outcome measure. Establishing baseline data points is crucial to determining a consistent pattern of response from the outcome variable. This is to make an opinion that continued testing of the same measurements without the intervention present would elicit similarly consistent results within the observed measurement ranges. From this, it allows the infereance that the responses of the outcome measures when the intervention is introduced is due to the intervention alone and no other external factors.

A blinded assessor who is a qualified physiotherapist and qualified to deliver the relevant testing measures will conduct all testing sessions that involve elements of clinical subjectivity throughout the study (e.g. functional mobility and functional independence assessments etc). A non-blinded, accredited exercise physiologist or physiotherapist will deliver testing sessions for the performance, biomechanical, health, fitness and strength measures and a mixture of blinded and non-blinded will be employed for psychosocial testing and conducting of interviews by testers who are accredited exercise physiologists or occupational therapists.
Control group
Active

Outcomes
Primary outcome [1] 340190 0
Individual sporting performance (time)
Assessment method [1] 340190 0
For Swimming, Wheelchair racing, Frame running, Hand cycling, Para-rowing/canoe: Time taken to complete the set distance (minutes, seconds) assessed using a stopwatch
Timepoint [1] 340190 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Primary outcome [2] 340192 0
Individual sporting performance (average velocity)
Assessment method [2] 340192 0
For Swimming, Wheelchair racing, Frame running, Hand cycling, Para-rowing/canoe: Average velocity during timed race (average m/s) calculated by using time assessed via stopwatch and the distance covered assessed via tape measures/distance measuring devices For Seated throw (discus, shot put, club throw) Average velocity during throw (average m/s) calculated by using time assessed via stopwatch and the distance covered assessed via tape measures/distance measuring devices
Timepoint [2] 340192 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Primary outcome [3] 340193 0
Individual sporting performance (distance)
Assessment method [3] 340193 0
For Swimming, Wheelchair racing, Frame running, Hand cycling, Para-rowing/canoe: Distance covered assessed via tape measures/distance measuring devices, number of stops during timed race (metres, # of stops) assessed via tape measures/distance measuring devices For Seated throw (discus, shot put, club throw): Distance of Throw (metres) assessed via tape measures
Timepoint [3] 340193 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [1] 443323 0
Functional mobility/independence (This is a primary outcome measure)
Assessment method [1] 443323 0
The following assessments of functional mobility are diagnostic specific and have been validated for use in specific populations. The participant's clinical diagnosis will determine which functional mobility assessment will be used. Only one assessment will be used for each participant to measure functional mobility/independece across the course of the project. Spinal cord injury - Test of Wheeled Mobility (TOWM) + Wheelie Test (these are both completed together) Cerebral Palsy - Gross Motor Function Measure Item set 66 (GMFM-66) Multiple Sclerosis - Multiple Sclerosis Functional Composite (MSFC) Traumatic Brain Injury - Physical Abilities and Mobility Scale (PAMS)
Timepoint [1] 443323 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [2] 443324 0
Functional Independence (Spinal Cord Injury specific)
Assessment method [2] 443324 0
Spinal Cord Injury Measure Version 3 (SCIM-III) (score 0-100) delivered via interview
Timepoint [2] 443324 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [3] 443328 0
Functional Independence
Assessment method [3] 443328 0
Functional Independence Measure (FIM) (score 18-126) delivered via interview
Timepoint [3] 443328 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [4] 443329 0
Function of fine motor skills and performance of daily tasks
Assessment method [4] 443329 0
Canadian Occupational Performance Measure (COPM) + Timed testing battery based on participant’s COPM chosen tasks (Identifying and prioritising functional tasks based on relevance, significance and difficulty aligns with person-centred care by acting as goal setting. Participants will select five key functional or fine motor tasks from a list and complete the COPM scoring sheet once per SCED phase. A testing battery of their five tasks will also be completed by the participant directly after the COPM scoring sheet once per phase. Following this, they will perform a testing battery for their chosen tasks, receiving instructions (e.g., combing hair, making a sandwich) and completing each task in their preferred way to measure proficiency in minutes or seconds. These tasks involve minimal risk, as they require only fine motor skills with no significant physical or cardiovascular exertion. A qualified physiotherapist will supervise all testing as a blinded assessor.
Timepoint [4] 443329 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [5] 443330 0
Heart rate recovery (HRR) (bpm) (This is a primary outcome measure)
Assessment method [5] 443330 0
6-minute sub-maximal effort test and 30-second maximum effort test using specialised cardiorespiratory equipment (e.g arm ergometer, rowing machine etc))
Timepoint [5] 443330 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [6] 443331 0
Intensity of training/testing activities (Rating of Perceived Exertion (RPE) (Omni/Borg/Modified Borg))
Assessment method [6] 443331 0
RPE will be recorded during the following activities: 6-minute sub-maximal effort test using specialised cardiorespiratory equipment (e.g arm ergometer, rowing machine etc)) (Aerobic fitness) 30-second maximum effort test using specialised cardiorespiratory equipment (e.g arm ergometer, rowing machine etc)) VALD Isometric Strength Testing Training sessions during each 16-week intervention phase
Timepoint [6] 443331 0
RPE will be recorded during every training/testing sessions. Training will occur up to 3 time each week during both 16-week intervention phases. Testing will occur twice per week during the baseline and withdrawal phases, and once each week during the intervention phases.
Secondary outcome [7] 443332 0
Velocity (m/s)
Assessment method [7] 443332 0
6-minute sub-maximal effort test and 30-second maximum effort test using specialised cardiorespiratory equipment (e.g arm ergometer, rowing machine etc))
Timepoint [7] 443332 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [8] 443333 0
Energy output (kJ)
Assessment method [8] 443333 0
6-minute sub-maximal effort test and 30-second maximum effort test using specialised cardiorespiratory equipment (e.g arm ergometer, rowing machine etc))
Timepoint [8] 443333 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [9] 443334 0
Distance travelled (m)
Assessment method [9] 443334 0
6-minute sub-maximal effort test and 30-second maximum effort test using specialised cardiorespiratory equipment (e.g arm ergometer, rowing machine etc))
Timepoint [9] 443334 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [10] 443335 0
Revolutions per minute (rpm)
Assessment method [10] 443335 0
6-minute sub-maximal effort test and 30-second maximum effort test using specialised cardiorespiratory equipment (e.g arm ergometer, rowing machine etc))
Timepoint [10] 443335 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [11] 443336 0
Blood lactate (via skin prick)
Assessment method [11] 443336 0
Post performing a 30-second maximum effort test using specialised cardiorespiratory equipment (e.g arm ergometer, rowing machine etc)) using EDGE lactate testing meter kit (mmol/L) Adverse events may include dizziness or feeling unwell from seeing/drawing of blood. During testing if participants experience this the testing will be ceased immediately and they will be able to take due time to rest and recover providing a safe and calm environment for them. They will be provided with water and adequate ariflow. On the consent form, participants will select whether they consent to this specific aspect of the project, and may consent to the rest of the project but choose not to participate in blood sampling. Even if participants initially consent, then change their mind, they can withdraw their consent for blood sampling at any point while continuing the rest of the project.
Timepoint [11] 443336 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [12] 443339 0
Estimated oxygen efficiency (VO2 maximum)
Assessment method [12] 443339 0
VO2 (mL/kg/min) assesed via a 6-minute, sub-maximal effort test using specialised cardiorespiratory equipment. Each participant will be fitted with a MetaMax Mask.
Timepoint [12] 443339 0
Every 3 months throughout the project from the start date of the project.
Secondary outcome [13] 443341 0
Maximum isometric muscular force production (N) (This is a primary outcome measure)
Assessment method [13] 443341 0
Isometric Strength Testing using a VALD dynamometer
Timepoint [13] 443341 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [14] 443342 0
Rate of force development (N/s)
Assessment method [14] 443342 0
Isometric Strength Testing using a VALD dynamometer
Timepoint [14] 443342 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [15] 444691 0
Impulse (Ns)
Assessment method [15] 444691 0
Isometric Strength Testing using a VALD dynamometer
Timepoint [15] 444691 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [16] 444692 0
Time to maximum force (s)
Assessment method [16] 444692 0
Isometric Strength Testing using a VALD dynamometer
Timepoint [16] 444692 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [17] 444693 0
Resistance (kg)
Assessment method [17] 444693 0
Isometric Strength Testing using a VALD dynamometer
Timepoint [17] 444693 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [18] 444694 0
Maximum Strength (kg lifted)
Assessment method [18] 444694 0
1-3RM strength testing
Timepoint [18] 444694 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [19] 444953 0
Body composition (this is a primary measure)
Assessment method [19] 444953 0
Lean mass (kg) measured via a Bioelectrical Impedance Analysis (BIA) device
Timepoint [19] 444953 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [20] 444954 0
Body composition
Assessment method [20] 444954 0
Lean mass (kg) measured via Dual-Energy X-ray Absorptiometry (DEXA scan):
Timepoint [20] 444954 0
Every 3 months throughout the project from the start date of the project.
Secondary outcome [21] 444955 0
Blood lipid levels (via skin prick)
Assessment method [21] 444955 0
Total Cholesterol (mmol/L) measured via CardioChek PA Analyser (Adverse events may include dizziness or feeling unwell from seeing/drawing of blood. During testing if participants experience this the testing will be ceased immediately and they will be able to take due time to rest and recover providing a safe and calm environment for them. They will be provided with water and adequate ariflow. On the consent form, participants will select whether they consent to this specific aspect of the project, and may consent to the rest of the project but choose not to participate in blood sampling. Even if participants initially consent, then change their mind, they can withdraw their consent for blood sampling at any point while continuing the rest of the project.)
Timepoint [21] 444955 0
Every 3 months throughout the project from the start date of the project.
Secondary outcome [22] 444956 0
Respiratory Function
Assessment method [22] 444956 0
FEV1/FVC Ratio measured via Vitalograph ALPHA D Spirometry device
Timepoint [22] 444956 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [23] 444957 0
Health Related Quality of Life (HRQOL) (This is a primary outcome measure)
Assessment method [23] 444957 0
WHOQOL Bref
Timepoint [23] 444957 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [24] 444958 0
Quality of Life
Assessment method [24] 444958 0
Each of the below measures are diagnostic specific. The test which is delivered to the participant will depend on their clinical diagnosis: Spinal Cord Injury – SCI-QOL Cerebral Pasly –Short Form-36, PedsQL CP Module for teenagers (Child Reported)
Timepoint [24] 444958 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [25] 444959 0
Pain (diagnostic specific)
Assessment method [25] 444959 0
Spinal Cord Injury - International Spinal Cord Injury Pain Data Set Cerebral Palsy – Global pain VAS Scale
Timepoint [25] 444959 0
Weekly during baseline and both withdrawal phases. Fortnightly during both intervention phases. All completed on the same day of the week during each phase.
Secondary outcome [26] 444960 0
Pain (generalised, regardless of diagnosis)
Assessment method [26] 444960 0
Patient Global Impression of Change Scale (PGIC)
Timepoint [26] 444960 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [27] 444961 0
Participant Story
Assessment method [27] 444961 0
This is a composite outcome measure. Dat will be thematically analysed and may be used to create a short film about the participant's experiences. These will be measured via: Gathered via qualitative interview, asking questions regarding mood, sleep, experience in sport, identity etc. Interviews will be with participants, coaches, parents and other family members and will be recorded. These will be thematically analysed Individuals video/audio diaries with prompt questions (capturing mood, identity, social connection, fatigue, quality of life) These will be thematically analysed. Likert scales assessing pain, mood, fatigue, enjoyment (0-10)
Timepoint [27] 444961 0
Interviews will be conducted oncer per phase of the SCED. Individual video/audio diaries will be completed at minimum once per week during each SCED phase. Likert scales will be used weekly during the baseline and each withdrawal phase and fortnightly during each intervention phase of the SCED.
Secondary outcome [28] 444962 0
Depression
Assessment method [28] 444962 0
Depression and Anxiety Stress Scales (DASS-21)
Timepoint [28] 444962 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [29] 444963 0
Mood
Assessment method [29] 444963 0
Mood and feelings questionnaire (MFQ)
Timepoint [29] 444963 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [30] 444964 0
Mood
Assessment method [30] 444964 0
Profile of Moods States (POMS-SF) - Short Form
Timepoint [30] 444964 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [31] 444965 0
Sleep
Assessment method [31] 444965 0
Minutes in each phase of sleep (REM, deep etc) measured via Fitbit Charge Sleep Data
Timepoint [31] 444965 0
Fitbit charge sleep data will be downloaded weekly during each phase of the SCED.
Secondary outcome [32] 444966 0
Fatigue
Assessment method [32] 444966 0
Fatigue Severity Scale (FSS)
Timepoint [32] 444966 0
Once or twice per each phase of the SCED in the final week of the phase.
Secondary outcome [33] 444967 0
Training volume and intensity
Assessment method [33] 444967 0
Subjective notes written by the members of the research team delivering each session. This will include information such as: Training minutes Session content Training intensity
Timepoint [33] 444967 0
Every attended session
Secondary outcome [34] 444968 0
Full body range of motion (ROM)
Assessment method [34] 444968 0
Goniometer (degrees)
Timepoint [34] 444968 0
Every 3 months throughout the project from the start date of the project.
Secondary outcome [35] 444969 0
Coordination
Assessment method [35] 444969 0
Upper limb unilateral tapping task (# of correctly coordinated taps)
Timepoint [35] 444969 0
Every 3 months throughout the project from the start date of the project.
Secondary outcome [36] 445943 0
RPE minutes (calculated by multiplying reported RPE and reported minutes of exercises) (this is a process measure)
Assessment method [36] 445943 0
Online form completed after each session, reporting RPE on a scale of 1-10 and activity time reported in minutes
Timepoint [36] 445943 0
Every session of physical activity completed (2x sports training, 1x gym-based training within intervention phases and any regular physical activity completed external of the program)
Secondary outcome [37] 445944 0
Subjective participant information and adverse events (this is a process measure)
Assessment method [37] 445944 0
Clinical notes (SOAP - Subjective, Objective, Assessment, Plan)
Timepoint [37] 445944 0
Completed at the conclusion of each sport-specific or gym-based training session or if a participant cancels a session for any reason (will likely be 3x each week per participant during intervention phases)..
Secondary outcome [38] 445947 0
Sleep Quality
Assessment method [38] 445947 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [38] 445947 0
Completed 1-2 times per SCED phase

Eligibility
Key inclusion criteria
· Have a neuromusculoskeletal impairment, defined as a movement disorder of neurological origin either progressive or non-progressive.
· Have a diagnosis that could lead to one of the below minimum impairment criteria for Para sport as defined by the International Paralympic Committee:
o Physical impairment: limb loss or deficiency, leg length difference, coordination impairments, such as hypertonia, ataxia, or athetosis, muscle weakness, restricted joint range of movement and short stature)
· Can travel to The University of Queensland’s St Lucia Campus on an agreed training and assessment and training schedule.
· Are medically fit to participate in supervised moderate-to-high intensity physical activity.
· Intellectually capable of understanding, comprehending and engaging with an agreed supervised exercise and testing intensity and schedule which will be assessed using the University of California, San Diego Brief Assessment of Capacity and Consent (Jeste, et al., 2007).
· Have no medical conditions that are made worse by participating in exertion-based sports with performance determinants including;
o speed, endurance, and strength (e.g., swimming, wheelchair racing, cycling, seated throwing).
Minimum age
12 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Major surgery currently scheduled or received in the past 6 months.
• Intellectual disability which impacts upon the ability of an athlete to follow the instructions to complete the testing and training protocol as required. The impact of their intellectual disability will be assessed using the University of California, San Diego Brief Assessment of Capacity and Consent.
• Severe cardiovascular, metabolic or pulmonary risk.
• Compromised skin integrity that is contagious or severe in nature.
• Pain levels which affect ability to engage in exercise.
• Significant dysphagia or oromotor dysfunction with an associated increase in the risk of aspiration.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/05/2025
Actual
30/06/2025
Date of last participant enrolment
Anticipated
31/12/2031
Actual
Date of last data collection
Anticipated
28/03/2033
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318067 0
Charities/Societies/Foundations
Name [1] 318067 0
The Sporting Hasbeens
Country [1] 318067 0
Australia
Funding source category [2] 318473 0
Charities/Societies/Foundations
Name [2] 318473 0
St Joseph's College, Gregory Terrace
Country [2] 318473 0
Australia
Primary sponsor type
Individual
Name
Professor Sean Tweedy - University of Queensland, School of Human Movement and Nutrition Sciences
Country
Australia
Secondary sponsor category [1] 320421 0
None
Name [1] 320421 0
Country [1] 320421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316680 0
The University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 316680 0
Ethics committee country [1] 316680 0
Australia
Date submitted for ethics approval [1] 316680 0
10/12/2024
Approval date [1] 316680 0
28/03/2025
Ethics approval number [1] 316680 0
2024002310

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 138642 0
Prof Sean Tweedy
Address 138642 0
School of Human Movement and Nutrition Sciences the University of Queensland, Human Movement Studies Building, 26b Union Road, St Lucia QLD 4067
Country 138642 0
Australia
Phone 138642 0
+61 7 33656638
Email 138642 0
s.tweedy@uq.edu.au
Contact person for public queries
Name 138643 0
Sean Tweedy
Address 138643 0
School of Human Movement and Nutrition Sciences the University of Queensland, Human Movement Studies Building, 26b Union Road, St Lucia QLD 4067
Country 138643 0
Australia
Phone 138643 0
+61 7 33656638
Email 138643 0
s.tweedy@uq.edu.au
Contact person for scientific queries
Name 138644 0
Sean Tweedy
Address 138644 0
School of Human Movement and Nutrition Sciences the University of Queensland, Human Movement Studies Building, 26b Union Road, St Lucia QLD 4067
Country 138644 0
Australia
Phone 138644 0
+61 7 33656638
Email 138644 0
s.tweedy@uq.edu.au

Data sharing statement
Will the study consider sharing 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.