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
27/04/2025
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the intervention, with shorter periods (5-weeks) of rest in following each intervention phase where the intervention is withdrawn.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)
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)
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)
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)
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)
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
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
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)
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))
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
Timepoint [21] 444955 0
Every 3 months throughout the project from the start date of the project.
Secondary outcome [22] 444956 0
Respiratory Function
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)
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
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)
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)
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
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
Timepoint [28] 444962 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [29] 444963 0
Mood
Timepoint [29] 444963 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [30] 444964 0
Mood
Timepoint [30] 444964 0
Once per each phase of the SCED in the final week of the phase.
Secondary outcome [31] 444965 0
Sleep
Timepoint [31] 444965 0
Fitbit charge sleep data will be downloaded weekly during each phase of the SCED.
Secondary outcome [32] 444966 0
Fatigue
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
Timepoint [33] 444967 0
Every attended session
Secondary outcome [34] 444968 0
Full body range of motion (ROM)
Timepoint [34] 444968 0
Every 3 months throughout the project from the start date of the project.
Secondary outcome [35] 444969 0
Coordination
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)
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)
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
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
Not yet recruiting
Date of first participant enrolment
Anticipated
7/05/2025
Actual
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
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
Address
Country
Australia
Secondary sponsor category [1] 320421 0
None
Name [1] 320421 0
Address [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
Trial related presentations / publications
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
Fax 138642 0
Email 138642 0
[email protected]
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
Fax 138643 0
Email 138643 0
[email protected]
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
Fax 138644 0
Email 138644 0
[email protected]

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.