Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000517572
Ethics application status
Approved
Date submitted
12/04/2024
Date registered
26/04/2024
Date last updated
11/08/2024
Date data sharing statement initially provided
26/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Quiet Minds for Cardio Kids - Exploring the Effect of Physical Activity on Brain and Psychological Development in Children with and without ADHD
Scientific title
Exploring the Effect of Physical Activity on Brain and Psychological Development in Children with and without ADHD
Secondary ID [1] 311915 0
The Waterloo Foundation (TWF) 2013-5414
Universal Trial Number (UTN)
Trial acronym
QUICKS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD) 333507 0
Condition category
Condition code
Mental Health 330185 330185 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 330299 330299 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for this study is a tennis-based physical activity program that mixes aerobic workouts, music, and socially inclusive physical activities. The intervention has been developed specifically for this trial.

The intervention will be delivered face-to-face in small groups (up to six participants) and will take place at local sporting clubs and/or schools in the Melbourne (Australia) metropolitan area. Materials for the intervention include sporting equipment (cones, line markers, agility ladder), tennis balls, tennis racquets, and a speaker to play music.

Participants will take part in the intervention through a one-week intensive block (4 x 45min sessions) and then twice per week (2 x 45min sessions) for eight weeks during the school term. The intervention will be delivered by sports coaches who have experience conducting physical activity sessions with children and have a current First Aid qualification.

Each session consists of a dynamic warm-up (approximately 5 minutes), tennis-based activities (skill-based exercises, approximately 30 minutes including rest time), and non-tennis activities (cardio-based exercises, approximately 10 minutes including rest time). The sessions will be accompanied by music from a standardised music track-list.

The one-week intensive block at the beginning of the program (Week 1) will include activities related to ground strokes (forehands, backhands), net game (volleys), transition game (approaching the net) and all court activities (activities that combine ground strokes, transition to the net, and volleys).

Tennis-based activities will then be themed across the school term (Weeks 2-9). Weeks 2-3 will focus on ground strokes (4x45 min sessions), Weeks 4-5 will focus on net game (4x45 min sessions in total), Weeks 6-7 will focus on transitioning to the net (4x45min sessions) and Weeks 8-9 will focus on all court activities (4x45min sessions).

The tennis-based and non-tennis-based activities will be of moderate to vigorous intensity. The intensity of the activities will be assessed using the Borg Rating of Perceived Exertion (RPE).

Members of the research team will regularly contact participating families via phone and email to schedule the intervention sessions, promote adherence to the intervention and answer questions that may arise.

To monitor adherence to the intervention, attendance will be recorded by a member of the research team.
Intervention code [1] 328408 0
Lifestyle
Comparator / control treatment
This study uses a waitlist period (nine weeks) as the comparator/control treatment. Participants will complete their usual physical activities during the waitlist period.
Control group
Active

Outcomes
Primary outcome [1] 337975 0
ADHD symptom severity
Timepoint [1] 337975 0
Baseline, 10 (primary endpoint) and 20 weeks post-intervention commencement
Primary outcome [2] 337976 0
Inhibitory control
Timepoint [2] 337976 0
Baseline, 10 (primary endpoint) and 20 weeks post-intervention commencement
Primary outcome [3] 337977 0
Task switching
Timepoint [3] 337977 0
Baseline, 10 (primary endpoint) and 20 weeks post-intervention commencement
Secondary outcome [1] 433967 0
Working memory [This is an additional primary outcome]
Timepoint [1] 433967 0
Baseline, 10 (primary endpoint) and 20 weeks post-intervention commencement
Secondary outcome [2] 434291 0
White matter organisation [This is an additional primary outcome]
Timepoint [2] 434291 0
Baseline, 10 (primary endpoint) and 20 weeks post-intervention commencement
Secondary outcome [3] 434293 0
Grey matter organisation [This is an additional primary outcome]
Timepoint [3] 434293 0
Baseline, 10 (primary endpoint) and 20 weeks post-intervention commencement
Secondary outcome [4] 434294 0
Functional connectivity [This is an additional primary outcome]
Timepoint [4] 434294 0
Baseline, 10 (primary endpoint) and 20 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Children with or without a prior diagnosis of ADHD
Minimum age
8 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Intellectual disability, serious medical condition, genetic disorder, moderate-severe sensory impairment or neurological problem

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)
Participants will be allocated to the intervention or the waitlist control group via dynamic random allocation (minimisation). This method follows a different principle to typical randomisation. The initial participant will be randomly allocated to the intervention or the waitlist control group, and then for each subsequent participant allocated, the research team will determine whether to allocate the participant to the intervention or the waitlist control group based on different characteristics including ADHD diagnosis, sex, and age. This will be used to achieve a better balance of participant characteristics in the intervention and the waitlist control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants are assigned to the treatment group, or the waitlist control group using dynamic random allocation (minimisation) and complete a baseline assessment. The treatment group begins the intervention following their baseline assessment. The waitlist control group waits ten weeks following their baseline assessment and then begins the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 120 participants (60 participants in the ADHD group and 60 participants in the non-ADHD group) will take part in this study.

The sample size is based on medium effect sizes in recent meta-analyses examining the benefits of physical activity for children with ADHD, comparable research showing white matter and resting state functional connectivity changes following physical activity in samples of 30-40 children, and power analyses for univariate repeated measures designs using medium effect sizes (f = 0.25), alpha = .05, and 80% power.

Data for this study will be analysed quantitatively. Change in ADHD symptom severity and executive functions following the intervention will be analysed using univariate repeated measures designs and/or linear mixed models. Structural and functional brain changes following the intervention will be analysed using univariate repeated measures designs, seed-to-voxel analyses, and permutation-based inference testing.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
4/07/2024
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
120
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316262 0
Charities/Societies/Foundations
Name [1] 316262 0
The Waterloo Foundation (TWF)
Country [1] 316262 0
United Kingdom
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 318451 0
None
Name [1] 318451 0
Address [1] 318451 0
Country [1] 318451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315082 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 315082 0
Ethics committee country [1] 315082 0
Australia
Date submitted for ethics approval [1] 315082 0
Approval date [1] 315082 0
04/04/2024
Ethics approval number [1] 315082 0
2024-008

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

Contacts
Principal investigator
Name 133618 0
Dr Ian Fuelscher
Address 133618 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 133618 0
Australia
Phone 133618 0
+61 3 9244 6259
Fax 133618 0
Email 133618 0
[email protected]
Contact person for public queries
Name 133619 0
Ian Fuelscher
Address 133619 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 133619 0
Australia
Phone 133619 0
+61 3 9244 6259
Fax 133619 0
Email 133619 0
[email protected]
Contact person for scientific queries
Name 133620 0
Ian Fuelscher
Address 133620 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 133620 0
Australia
Phone 133620 0
+61 3 9244 6259
Fax 133620 0
Email 133620 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
The ethical approval for this study only permits group level data to be shared publicly.


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.