Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001090707
Ethics application status
Approved
Date submitted
22/07/2022
Date registered
8/08/2022
Date last updated
25/08/2022
Date data sharing statement initially provided
8/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploratory research into the effects of exercise, rhythm and music on Central Auditory Processing Disorder or 'Listening Difficulty' in children.
Scientific title
A randomised clinical trial investigating the effects of exercise alone, or exercise with rhythm and music, on the Central Auditory Processing of children with normal hearing thresholds but reported listening difficulty.
Secondary ID [1] 307641 0
None
Universal Trial Number (UTN)
U1111-1280-4235
Trial acronym
CAPD-ME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Auditory Processing Disorders 327088 0
Physical Literacy 327089 0
Fitness 327141 0
Condition category
Condition code
Neurological 324274 324274 0 0
Other neurological disorders
Ear 324276 324276 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of an exercise program both developed and delivered by Accredited Exercise Physiologists, within the School of Human Sciences at The University of Western Australia.

This program consists of group sessions of 10 children lasting 45 minute per session, 2 times a week for 8 weeks. The exercises are of moderate intensity and designed to target cardiorespiratory fitness, motor skill development and muscular strength. These activities will either be performed to the rhythm of music, involve creating and repeating rhythms during the activities, or use musical or rhythmic cues (as opposed to visual cues or verbal instructions) to change the activities. Adherence will be monitored via session attendance checklists. In addition, session intensity will be quantified through heart-rate monitoring (Polar FT7 monitor worn by a sample of participants) and Rating of Perceived Exertion (Borg Scale) during exercise sessions. This data will also allow confirmation of matched activity levels across the two groups.

Examples of activities include:
1. 'Strength Training' including squats, pushups, and lunges performed in time with age-appropriate music (for example, 2 counts for concentric phase and 2 counts for eccentric phase).
2. 'Game of Freeze' using cardiorespiratory movements such as hopping, skipping, star jumps and bopping down on the ground in response to a predetermined auditory cue (for example, music stopping, change in song, or change in tempo).
3. Hopscotch performed in time with music or to a pre-determined rhythm as demonstrated and cued by instructor clapping.
Intervention code [1] 324095 0
Treatment: Other
Comparator / control treatment
The control group consists of an identical program with matched activities, without the elements of rhythm and music incorporated into the exercises. Instead children will be given verbal instructions, visual cues, or work at their own pace depending on the activity.

Examples of matched activities include:
1. 'Strength Training' including squats, pushups, and lunges performed at participant’s desired tempo (with control).
2. 'Game of Freeze' using cardiorespiratory movements such as hopping, skipping, star jumps and bopping down on the ground in response to visual cue (instructor bopping down to the ground).
3. Hopscotch performed at participant’s desired speed.
Control group
Active

Outcomes
Primary outcome [1] 332086 0
Auditory Evoked Potentials - % change in amplitude of mismatch negativity or MMN (assessed via electroencephalogram)
Timepoint [1] 332086 0
pre-intervention (within 2 months before intervention), post-intervention (within 1 month post intervention, primary endpoint), 12 weeks post-intervention, 16 weeks post-intervention
Primary outcome [2] 332087 0
Auditory Evoked Potentials - % change in amplitude of P300 (assessed via electroencephalogram)
Timepoint [2] 332087 0
pre-intervention (within 2 months before intervention), post-intervention (within 1 month post intervention, primary endpoint), 12 weeks post-intervention, 16 weeks post-intervention
Primary outcome [3] 332088 0
Auditory Closure - % change in Low Pass Filtered Words test. This is a primary outcome.
Timepoint [3] 332088 0
pre-intervention (within 2 months before intervention), post-intervention (within 1 month post intervention, primary endpoint), 12 weeks post-intervention, 16 weeks post-intervention
Secondary outcome [1] 412170 0
Temporal Resolution - % change in Random Gap Detection Test. This is a primary outcome.
Timepoint [1] 412170 0
pre-intervention (within 2 months before intervention), post-intervention (within 1 month post intervention, primary endpoint), 12 weeks post-intervention, 16 weeks post-intervention
Secondary outcome [2] 412184 0
Temporal Sequencing - % change in Pitch Pattern Sequence. This is a primary outcome.
Timepoint [2] 412184 0
pre-intervention (within 2 months before intervention), post-intervention (within 1 month post intervention, primary endpoint), 12 weeks post-intervention, 16 weeks post-intervention
Secondary outcome [3] 412185 0
Listening in Noise - % change in Listening in Spacialised Noise (Sentences) test. This is a primary outcome.
Timepoint [3] 412185 0
pre-intervention (within 2 months before intervention), post-intervention (within 1 month post intervention, primary endpoint), 12 weeks post-intervention, 16 weeks post-intervention
Secondary outcome [4] 412188 0
Cardiorespiratory Fitness - % change in The Fitkid Treadmill Test results. The total duration of the test minus the warm up, and participants body mass (as measured via digital scale) are inputed in to equations which provide a valid estimation of their VO2Peak.
Timepoint [4] 412188 0
pre-intervention (within 2 weeks before intervention), post-intervention (within 2 weeks post intervention),
Secondary outcome [5] 412189 0
Change in Muscular performance and upper body strength - % change in force produced using Handgrip Dynamometry (measured with Jamar Digital Handgrip Dynamometre adjusted according to participant handspan). Score determined by best of 3 trials for each hand.
Timepoint [5] 412189 0
pre-intervention (within 2 weeks before intervention), post-intervention (within 2 weeks post intervention),
Secondary outcome [6] 412190 0
Change in movement skills - % change in The PLAYfun Form results. The PlayFUN form measures participant proficiency in performing 18 movement skills within 5 domains (running, locomotor, object control (upper body), object control (lower body) and balance, stability, and body control). The scoring system provides an overall score representing motor skill proficiency, as well as a score for each sub-section, to quantify change over time.
Timepoint [6] 412190 0
pre-intervention (within 2 weeks before intervention), post-intervention (within 2 weeks post intervention),
Secondary outcome [7] 412191 0
Change in physical literacy - % change in the Physical Literacy in Children Questionnaire. This scale measures 30 items related to four broad domains: physical, psychological, social and cognitive. This then provides an overall score, as well as for each domain, to determine physical literacy of the child (higher score = higher physical literacy) which can be compared pre and post intervention period.
Timepoint [7] 412191 0
pre-intervention (within 2 weeks before intervention), post-intervention (within 2 weeks post intervention),
Secondary outcome [8] 412551 0
Health-Related Quality of Life - % change in overall score on child-completed KIDSCREEN-10 Index Questionnaire. This tool asks participants to reflect on how much they relate to 10 different statements (exploring various markers of social, emotional, psychological markers of wellbeing) when thinking about the past two weeks
Timepoint [8] 412551 0
pre-intervention (within 2 weeks before intervention), post-intervention (within 2 weeks post intervention),

Eligibility
Key inclusion criteria
- Children must be between ages 7-12 years
- Children and parent providing permission must be able to read/speak in English
- Children must experience listening difficulties as reported by a parent
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Children with a hearing loss
- Diagnosis of intellectual impairment as confirmed by parental reports
- Medical diagnoses which limits participation in exercise or auditory testing

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)
Permuted block randomisation, with stratification to balance for age and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous RCT’s in similar populations evaluating the same outcomes have used a priori calculations to determine 100 participants are required for 80% statistical power and therefore recruited 40-50 participants for the intervention arm. Our aim of 40 participants is in-line with feasibility trials and will be sufficient to fulfil the aims of this preliminary study.

Data will be screened for normality and other statistical assumptions. Descriptive statistics will be calculated using participant demographic information. Changes over time in outcome variables (that were assessed at pre- and post-intervention) will be assessed statistically using paired samples t-tests, and the magnitude of observed changes will be reported using standardised Cohen’s d effect sizes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/08/2022
Actual
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
23/04/2024
Actual
Sample size
Target
40
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 38165 0
6009 - Crawley

Funding & Sponsors
Funding source category [1] 311881 0
Charities/Societies/Foundations
Name [1] 311881 0
Channel 7 Telethon Trust
Country [1] 311881 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
School of Human Sciences M309
35 Stirling Highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 313384 0
Other Collaborative groups
Name [1] 313384 0
Telethon Kids Institute
Address [1] 313384 0
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS WA 6009
Country [1] 313384 0
Australia
Secondary sponsor category [2] 313385 0
Charities/Societies/Foundations
Name [2] 313385 0
Thriving In Motion Inc
Address [2] 313385 0
Parkway Entrance #3,
School of Human Science
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country [2] 313385 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311316 0
UWA Human Research Ethics Committee
Ethics committee address [1] 311316 0
Ethics committee country [1] 311316 0
Australia
Date submitted for ethics approval [1] 311316 0
11/05/2022
Approval date [1] 311316 0
25/07/2022
Ethics approval number [1] 311316 0

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

Contacts
Principal investigator
Name 120686 0
Dr Robyn Choi
Address 120686 0
The University of Western Australia
School of Human Sciences M309
35 Stirling Highway
Crawley WA 6009
Country 120686 0
Australia
Phone 120686 0
+61864883347
Fax 120686 0
Email 120686 0
[email protected]
Contact person for public queries
Name 120687 0
Nicola Linton
Address 120687 0
The University of Western Australia
School of Human Sciences M309
35 Stirling Highway
Crawley WA 6009
Country 120687 0
Australia
Phone 120687 0
+61 8 6488 7998
Fax 120687 0
Email 120687 0
[email protected]
Contact person for scientific queries
Name 120688 0
Robyn Choi
Address 120688 0
The University of Western Australia
School of Human Sciences M309
35 Stirling Highway
Crawley WA 6009
Country 120688 0
Australia
Phone 120688 0
+61864883347
Fax 120688 0
Email 120688 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


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.