Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001314718
Ethics application status
Approved
Date submitted
5/10/2022
Date registered
11/10/2022
Date last updated
1/02/2023
Date data sharing statement initially provided
11/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Sports Stars JIA- is a physiotherapist-led sports group feasible for children with Juvenile Idiopathic Arthritis?
Scientific title
Sports Stars JIA: The feasibility of a physiotherapist-led, peer-group sports intervention for children with Juvenile Idiopathic Arthritis
Secondary ID [1] 308118 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis 327824 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324904 324904 0 0
Physiotherapy
Inflammatory and Immune System 324965 324965 0 0
Other inflammatory or immune system disorders
Musculoskeletal 324966 324966 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Short name: Sports Stars

Participants will receive eight, weekly, 1-hour face-to-face group sessions (8h) in groups of 8 children. Intervention will target physical, social, cognitive and psychological components of Physical Literacy needed for participation in life-long physical activity. Every two weeks, children will be introduced to one of the four most popular Australian team-sports (soccer, netball, t-ball, cricket). Each session includes: (1) Physical coaching targeting the locomotor (e.g. running, weaving) and object control skills (e.g. catching, kicking) needed to participate in sport. (2) Cognitive coaching to introduce children to the rules of sport and the layout of a training session, to educate them on the importance and safety of physical activity for pain management, health and overall wellbeing, and to develop knowledge on how to participate in physical activity in an enjoyable way across their lifetime. (3) Social coaching to facilitate enjoyable teamwork experiences with peers in recreational and competitive environments. (4) Psychological coaching to enhance confidence and self-efficacy in pain management through participation in physical activity and reduce feelings of anxiety and/or reluctance to participate in physical activity due to symptoms of JIA. Sessions will be conducted in community parks by trained physiotherapists. Conducting sports-specific activities in a community environment will facilitate children’s transition from hospital-based medical intervention, into community sports participation. Children and parents will also receive 3x 2hr psycho-education sessions with a psychologist (W1, W4, W8) to address their understanding of safety and effectiveness of exercise in pain management for people with JIA, and to address anxiety or reluctance relating to participating in Sports Stars, transitioning to community sport, or self-efficacy for transition.

Intervention therapists will be qualified physiotherapists who receive Sports Stars training prior to providing intervention. A Sports Stars protocol will be provided that includes weekly exercise and progression programs with instructions and video resources to aid exercise selection for each child’s age, goals and skills. Therapists will consult with a Sports Stars expert (GC) to discuss program content and structure prior/during group provision. Each session, the therapist will record exercise type, level of difficulty and observed engagement for each child. At week 3 and 6, a Sports Stars expert not involved in assessment will perform a fidelity review and provide guidance on session delivery and recording if needed. Independent content analysis of fidelity review will determine compliance with the provided protocol (Feasibility element #3- Practical and able to be implemented (successfully delivered)).
Intervention code [1] 324572 0
Rehabilitation
Comparator / control treatment
Usual care. Children will continue to receive their usual physiotherapy care while they are in the waitlist group. This is anticipated to be no more than 2 physiotherapy appointments during the trial period.
Control group
Active

Outcomes
Primary outcome [1] 332709 0
Canadian Occupational Performance Measure (COPM) goals will be set using a modified method per previous studies. Goals will relate to 1) attendance at community physical activities and 2) involvement in community physical activities.
Timepoint [1] 332709 0
Immediately post intervention (8 weeks)
Secondary outcome [1] 414446 0
- Test of Gross Motor Development, 3rd edition (Sports activity performance)
Timepoint [1] 414446 0
Immediately post intervention (8 weeks)
Secondary outcome [2] 414447 0
- Bruininks-Oseretsky Test of Motor Proficiency, 2nd edition (Gross motor skill, balance, strength and agility)
Timepoint [2] 414447 0
Immediately post intervention- 8 weeks
Secondary outcome [3] 414448 0
- 10x5m Sprint test: Anaerobic capacity and power
Timepoint [3] 414448 0
Immediately post intervention- 8 weeks
Secondary outcome [4] 414449 0
- Dynamometry using the ‘Manual Muscle Testing 8’ (Strength)
Muscles include: Deltoid, Biceps, Wrist extensors, Quadriceps, Ankle dorsiflexors, Neck flexors, Gluteus medius, Gluteus maximus
Timepoint [4] 414449 0
Immediately post intervention- 8 weeks
Secondary outcome [5] 414450 0
Canadian Occupational Performance Measure (COPM) goals will be set using a modified method per previous studies. Goals will relate to specific physical sports skills.
Timepoint [5] 414450 0
Immediately post intervention- 8 weeks
Secondary outcome [6] 414451 0
Pain intensity visual analogue scale using the Juvenile Arthritis Multidimensional Assessment Report (JAMAR) and Juvenile Arthritis Disease Activity Score (JADAS) methods
Timepoint [6] 414451 0
Immediately post intervention- 8 weeks
Secondary outcome [7] 414452 0
- Pediatric Pain Screening Tool (Pain prognostic factors)
Timepoint [7] 414452 0
Immediately post intervention- 8 weeks
Secondary outcome [8] 414453 0
- PedsQL Multidimensional Fatigue Scale: (Fatigue)
Timepoint [8] 414453 0
Immediately post intervention- 8 weeks
Secondary outcome [9] 414454 0
- PA diary (diversity, location, social context and perceived exertion)
Timepoint [9] 414454 0
Immediately post intervention- 8 weeks
Secondary outcome [10] 414455 0
- Custom questionnaires regarding child/caregiver experience during assessment/intervention
Timepoint [10] 414455 0
Immediately post intervention- 8 weeks

Eligibility
Key inclusion criteria
- Diagnosis of JIA
- 7-12 years
- Able to attend three, 2hr assessments and 8-weeks of 1hr Sports Stars sessions in the region of QCH
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Primary diagnosis other than JIA
- Intellectual/behavioural condition precluding participation
- Admitted to hospital

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)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23310 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 38681 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 312373 0
Charities/Societies/Foundations
Name [1] 312373 0
Physiotherapy Research Foundation
Country [1] 312373 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 313940 0
Hospital
Name [1] 313940 0
Queensland Children's Hospital
Address [1] 313940 0
501 Stanley St, South Brisbane QLD 4101
Country [1] 313940 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311733 0
Children’s Health Queensland Human Research Ethics Committee (CHQ HREC)
Ethics committee address [1] 311733 0
Ethics committee country [1] 311733 0
Australia
Date submitted for ethics approval [1] 311733 0
21/11/2022
Approval date [1] 311733 0
21/12/2022
Ethics approval number [1] 311733 0
HREC/22/QCHQ/91209
Ethics committee name [2] 312338 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [2] 312338 0
Ethics committee country [2] 312338 0
Australia
Date submitted for ethics approval [2] 312338 0
05/01/2023
Approval date [2] 312338 0
06/01/2023
Ethics approval number [2] 312338 0
2023/HE000014

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

Contacts
Principal investigator
Name 122174 0
Dr Georgina Clutterbuck
Address 122174 0
The University of Queensland
St Lucia, QLD, 4072
Country 122174 0
Australia
Phone 122174 0
+61 0418332325
Fax 122174 0
Email 122174 0
[email protected]
Contact person for public queries
Name 122175 0
Georgina Clutterbuck
Address 122175 0
The University of Queensland
St Lucia, QLD, 4072
Country 122175 0
Australia
Phone 122175 0
+61 0418332325
Fax 122175 0
Email 122175 0
[email protected]
Contact person for scientific queries
Name 122176 0
Georgina Clutterbuck
Address 122176 0
The University of Queensland
St Lucia, QLD, 4072
Country 122176 0
Australia
Phone 122176 0
+61 0418332325
Fax 122176 0
Email 122176 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will not be available due to the personal nature of health data and identifiability of participants.


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.