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Trial registered on ANZCTR


Registration number
ACTRN12623000389606p
Ethics application status
Submitted, not yet approved
Date submitted
27/02/2023
Date registered
18/04/2023
Date last updated
18/04/2023
Date data sharing statement initially provided
18/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A 4-week physical activity and healthy lifestyle habits-based program effects on physical literacy, health-related quality of life, symptomatology and attention in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)
Scientific title
A 4-week physical activity and healthy lifestyle habits-based program effects on physical literacy, health-related quality of life, symptomatology and attention in children and adolescents with ADHD
Secondary ID [1] 309091 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention-Deficit/Hyperactivity Disorder (ADHD) 329163 0
Condition category
Condition code
Neurological 326135 326135 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group: an after-school intervention program based on the development of the domains that make up physical literacy will be implemented. Considering the duration of previous physical activity interventions in this population, a 4-week intervention period was established, with two 55-min sessions per week. All the sessions will be driven by physical education teachers and/or physical-sports educators.
The sessions will be divided into several parts, starting with a 5 min greeting and exchange of daily experiences, a 20-min block I of the session, a 20-min block II of the session and a 10-min cool-down for relaxation and feedback. Specifically, to develop the domains that make up physical literacy, the main part of the intervention will consist of two blocks of 20 min. Both blocks I and II will favour the development of physical competence through different physical activities. More specifically, block I will focus on the acquisition of content that will contribute to the development of the domains of knowledge and understanding and daily activity. And block II, in addition to favouring physical competence, will seek to improve motivation.
Block I: activities will be carried out to develop knowledge and understanding of concepts and attitudes related to healthy lifestyle habits and physical activity, through the activity "Card relay race". For this activity, participants will be divided into teams, which will be placed in rows. Each participant in each team carries a card (model) in his/her hand and will have to run individually to a table located about 30 metres away and, once there, he/she will find a series of cards similar to his/her own (stimuli), and will have to place the card in his/her hand on top of one of the cards on the table that corresponds to his/her own (i.e. look for the stimulus that corresponds to his/her model). Subsequently, he/she will do the race back so that the next partner can come out. The contents of the cards will be related to healthy lifestyle habits and in each session there will be an ini-tial brief explanation of the content to be developed that day. This activity, adapted from a previous study, is intended to improve attentional functioning as well as to acquire knowledge about healthy lifestyle habits, while at the same time practising physical activity. Thus contributing to two fundamental pillars of PL such as knowledge and understanding, daily activity and physical competence.
Block 2: The second block will be based on active play, as it is fundamental in the transmission of values and attitudinal content, as well as in the stimulation of social and civic relationships with others. Similar to previous studies on ADHD children, different ball games, multi-jumping, throwing games will be carried out. The games that will be played each week and their description is provided in PlaySport from the Ontario Physical Education and Health Association (http://www.playsport.net/ (accessed 25 January 2023).
Games will have a cooperative and competitive component due to the motivational benefits they can bring. Activities will be adapted to the initial level of the children.
The adherence or fidelity to the intervention will be monitored registering the attendance of participants at the sessions held.
Intervention code [1] 325537 0
Treatment: Other
Comparator / control treatment
Participants will continue with their usual after school activities (sports, music, languages learning...)
Control group
Active

Outcomes
Primary outcome [1] 334007 0
Physical literacy assessed using the Canadian Assessment of Physical Literacy Development (CAPL-2).
Timepoint [1] 334007 0
Before (week 0) and after the intervention treatment (week 5).
Secondary outcome [1] 419046 0
Health-related quality of life. It will be assessed using the Child health utility 9D (CHU9D). This is a self-report instrument (completed by the child) and a proxy-report questionnaire (completed by the caregiver). It consists of 9 items including 5 possible responses (scored from 1 to 5) that assess the child's or adolescent's current state in the following domains: worry, sadness, pain, tiredness, discomfort, school, sleep, daily routine and activities.
Timepoint [1] 419046 0
Before (week 0) and after the intervention treatment (week 5).
Secondary outcome [2] 419047 0
Attention Deficit Hyperactivity Disorder Test (ADHDT), which is designed to identify and assess ADHD in ages 3-23 years. It consists of 36 items in three subscales: (a) hyperactivity, (b) inattention and (c) impulsivity. The total score ranges from 0-72, with higher scores indicating greater and more severe ADHD-related symptomatology. All subscales will be assessed as a composite secondary outcome
Timepoint [2] 419047 0
Before (week 0) and after the intervention treatment (week 5).
Secondary outcome [3] 419048 0
Quality of attention and sustained attention of the participants. It will be assessed based on the Magellan Scale of Visual Attention (quotes). This is used to identify the presence of ADHD and to assess the intensity and impact of the symptomatology in each case. They make it possible to evaluate the ability to focus attention (Quality of Attention (QA)) and to maintain attentional effort over a period of time (Sustained Attention (SA)), as well as stability or performance over a relatively long period of time. To do this, children should look for and identify figures identical to the model presented. For 8-year-olds, the VAS-1 will be used, where 720 possible figures are presented, of which 140 are identical to the model, and the maximum time to complete the task is 6 minutes. For children between 9 and 16 years old, the EMAV-2 will be completed, where 1,820 figures are presented, 340 identical to the model, and the maximum time to complete the task is 12 minutes. Children's omissions and errors will be counted to assess their sustained attention and impulsivity, respectively. Their successes are transformed into centiles following the instructions in the scale manual and using the TIPI-SOFT software, to obtain their level of attentional quality. Both quality of attention and sustained attention will be assessed as a composite secondary outcome.
Timepoint [3] 419048 0
Before (week 0) and after the intervention treatment (week 5).

Eligibility
Key inclusion criteria
To be included in this project, participants have to meet the following eligibility criteria: 1) Clinical diagnosis of ADHD; 2) age between 8 and 16 years; 3) not suffer from pathologies that contraindicate the practice of exercise, limiting the execution of the physical activity program: 4) have authorisation from parents or legal guardians and; 5) accept participation in the study.
Minimum age
8 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
To present comorbidities with other neurodevelopmental or psychiatric disorders.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Participants will be randomly assigned to the experimental or control groups. Prior to enrolling participants (1:1) the Research Randomizer software (version 4.0, Geoffrey C. Urbaniak and Scott Plous, Middletown, CT, USA; http://www.randomizer.org) will be used in order to create a randomization sequence. A member of the research team with no active clinical involvement in the trial will conduct this process. Group assignment will be hidden in a password-protected computer file
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
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
1/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 25290 0
Spain
State/province [1] 25290 0

Funding & Sponsors
Funding source category [1] 313297 0
University
Name [1] 313297 0
University of Extremadura
Country [1] 313297 0
Spain
Primary sponsor type
University
Name
University of Extremadura
Address
Avda. de Elvas, s/n 06006, Badajoz.
Country
Spain
Secondary sponsor category [1] 315036 0
None
Name [1] 315036 0
None
Address [1] 315036 0
None
Country [1] 315036 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312523 0
Bioethics and Biosafety Committee at the University of Extremadura
Ethics committee address [1] 312523 0
Ethics committee country [1] 312523 0
Spain
Date submitted for ethics approval [1] 312523 0
17/03/2023
Approval date [1] 312523 0
Ethics approval number [1] 312523 0

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

Contacts
Principal investigator
Name 124966 0
Dr María Mendoza-Muñoz
Address 124966 0
Facultad de Ciencias del Deporte, Universidad de Extremadura, Avenida de la Universidad, s/n, 10003 Cáceres
Country 124966 0
Spain
Phone 124966 0
+34 927 25 74 60
Fax 124966 0
Email 124966 0
mamendozam@unex.es
Contact person for public queries
Name 124967 0
María Mendoza-Muñoz
Address 124967 0
Facultad de Ciencias del Deporte, Universidad de Extremadura, Avenida de la Universidad, s/n, 10003 Cáceres
Country 124967 0
Spain
Phone 124967 0
+34 927 25 74 60
Fax 124967 0
Email 124967 0
mamendozam@unex.es
Contact person for scientific queries
Name 124968 0
María Mendoza-Muñoz
Address 124968 0
Facultad de Ciencias del Deporte, Universidad de Extremadura, Avenida de la Universidad, s/n, 10003 Cáceres
Country 124968 0
Spain
Phone 124968 0
+34 927 25 74 60
Fax 124968 0
Email 124968 0
mamendozam@unex.es

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.