Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000102774
Ethics application status
Approved
Date submitted
21/07/2021
Date registered
24/01/2022
Date last updated
14/01/2024
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pedagogical Proposal of Tele-exercise Based on "Square Step-ping Exercise" in Preschoolers
Scientific title
Pedagogical Proposal of Tele-exercise Based on "Square Stepping Exercise" on Balance in Preschoolers
Secondary ID [1] 304846 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor development 322933 0
Cognitive development 322934 0
Condition category
Condition code
Musculoskeletal 320509 320509 0 0
Normal musculoskeletal and cartilage development and function
Mental Health 321570 321570 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group will receive Tele-Square Step Exercise training (Tele-SSE), 3 times per week and for 9 months. Each training session will have a duration close to 60 minutes and will be supervised by a sports physical educator. The intervention will be applied in groups of no more than 25. At the beginning of the intervention, the instructor will explain the training guidelines. All sessions will be followed by video-conference through the digital whiteboard placed in every early childhood education classroom. The Tele-SSE will be performed on a fine carpet of 200 x 80 cm, divided into 40 squares of 20 x 20 cm, adapted to participants' morphological characteristics. Participants will execute the SSE exercise divided in two tapestries simultaneously. SSE includes a total of 200 different movement patterns which are classified, according to their difficulty, into three general levels: beginner, intermediate and advanced. There will be a progression in the levels in the proposed intervention. The beginner level has two sub-levels, while the intermediate and advanced levels have 3 sub-levels. The proposed intervention will include a progression along the first six levels until the advanced level 1. The greater levels will be combined with other patterns that include colours or flexible surfaces that make the task even more difficult and encourage cooperative work among participants. Likewise, participants will start with simple two-step movement patterns and, step by step, they will perform more complex patterns that will require greater number of steps per sequence, multidirectional movements and even the performance of other motor skills, such as jumping with feet together, jumping on one leg, etc. The difficulty of the stepping pattern will be increased one per month, considering the levels previously indicated. A checklist will be used by the study personnel in order to control the participants' adherence to the intervention.
Intervention code [1] 321227 0
Treatment: Other
Comparator / control treatment
Control group will continue with their usual school day and normal classes, carrying out activities that are scheduled for each moment of the day (handicrafts, cards, free play, etc.) and only participate in assessments.
Control group
Active

Outcomes
Primary outcome [1] 328341 0
Balance, assessed using the one-leg balance test
Timepoint [1] 328341 0
Baseline, and 3, 6, 9, and 12 (primary endpoint) months post-intervention commencement
Secondary outcome [1] 398646 0
Body mass index (BMI), assessed as a composite of weight measured using electronic standing scales and height measured using a stadiometer, etc.
Timepoint [1] 398646 0
Baseline, and 3, 6, 9, and 12 months post-intervention commencement
Secondary outcome [2] 398647 0
Waist circumference, assessed using a measuring tape placed at the level of the narrowest point of the waist
Timepoint [2] 398647 0
Baseline, and 3, 6, 9, and 12 months post-intervention commencement
Secondary outcome [3] 398648 0
Handgrip strength, assessed using a dynamometer
Timepoint [3] 398648 0
Baseline, and 3, 6, 9, and 12 months post-intervention commencement
Secondary outcome [4] 398649 0
Lower limbs strength though a standing long jump test
Timepoint [4] 398649 0
Baseline, and 3, 6, 9, and 12 months post-intervention commencement
Secondary outcome [5] 398650 0
Speed-agility, assessed using the 4 × 10 m test
Timepoint [5] 398650 0
Baseline, and 3, 6, 9, and 12 months post-intervention commencement
Secondary outcome [6] 398651 0
Cardiorespiratory fitness, assessed using the 20-m shuttle run test
Timepoint [6] 398651 0
Baseline, and 3, 6, 9, and 12 months post-intervention commencement
Secondary outcome [7] 398652 0
Executive function, assessed by two tests within the battery will be performed: the flanker inhibitory control and attention test, a measure of inhibitory control in the context of selective visual attention, and the dimensional change card sort, related to the cognitive flexibility and attention. In the first one, children must focus on a stimulus while inhibiting attention to the flanking ones (fish flanked by two fish on each side). In the second one, two target pictures are presented which vary in two dimensions (shape and colour). Children must sort them as indicated by an audiorecorded cue word.
Timepoint [7] 398652 0
Baseline, and 3, 6, 9, and 12 months post-intervention commencement
Secondary outcome [8] 398653 0
Episodic memory, assessed using the picture sequence memory test, with different versions for 3–4 and 5–6 years. In any case, children must reproduce previously-shown object sequences.
Timepoint [8] 398653 0
Baseline, and 3, 6, 9, and 12 months post-intervention commencement
Secondary outcome [9] 398654 0
Language, assessed using the picture vocabulary test, which covers from 3 years and
above. The children must select the picture that most closely matches the meaning of
an audio-recorded word
Timepoint [9] 398654 0
Baseline, and 3, 6, 9, and 12 months post-intervention commencement
Secondary outcome [10] 404533 0
Attention, assessed by two tests within the battery will be performed: the flanker inhibitory control and attention test, a measure of inhibitory control in the context of selective visual attention, and the dimensional change card sort, related to the cognitive flexibility and attention. In the first one, children must focus on a stimulus while inhibiting attention to the flanking ones (fish flanked by two fish on each side). In the second one, two target pictures are presented which vary in two dimensions (shape and colour). Children must sort them as indicated by an audiorecorded cue word.
Timepoint [10] 404533 0
Baseline, and 3, 6, 9, and 12 months post-intervention commencement

Eligibility
Key inclusion criteria
a) children aged between 3 and 6 years old; b) To be enrolled in a public early childhood education centre in the autonomous community of Extremadura; c) to complete and sign the informed consent form by their parents or legal guardians; d) children's consent and voluntariness to participate in the intervention
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Suffer some condition or inconvenience that prevent the normal practice of physical activity.

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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
15/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment outside Australia
Country [1] 23997 0
Spain
State/province [1] 23997 0
Extremadura

Funding & Sponsors
Funding source category [1] 309218 0
Self funded/Unfunded
Name [1] 309218 0
Country [1] 309218 0
Primary sponsor type
University
Name
Universidad de Extremadura
Address
Avenida de la universidad s/n, 10003, Cáceres (Cáceres)
Country
Spain
Secondary sponsor category [1] 310180 0
None
Name [1] 310180 0
Address [1] 310180 0
Country [1] 310180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309069 0
Bioethics and Biosafety Committee at the University of Extremadura
Ethics committee address [1] 309069 0
University of Extremadura, Avenida de la Universidad, s/n, 10003 Cáceres, Spain
Ethics committee country [1] 309069 0
Spain
Date submitted for ethics approval [1] 309069 0
04/06/2021
Approval date [1] 309069 0
17/06/2021
Ethics approval number [1] 309069 0
95/2021

Summary
Brief summary
Early Childhood Education aims to achieve motor, cognitive, emotional, and social development of preschoolers by providing them with a variety of learning opportunities. The Square Stepping Exercise (SSE) is a balance and lower limb strength training programme used to prevent falls and stimulate cognitive function in older adults. This project aims to propose a SSE tele-exercise (Tele-SSE) protocol to evaluate its effects on motor and cognitive development of children between 3 and 6 years. A randomized controlled trial with experimental (Tele-SSE) and control (usual education) groups will be carried out. The application of Tele-SSE will be performed for 9 months (three times per week) and one additional follow-up after the intervention at the beginning of the next academic year. One-hundred and two preschoolers will be recruited and randomly distributed into the two groups: experimental (n = 51) and control (n = 51). Although the main outcome will be balance due to the nature of the SSE, outcomes will include physical and motor (body mass index, waist circumference, handgrip and lower-limb strength, speed-agility, and cardiorespiratory fit-ness) and cognitive (executive functions and attention, episodic memory, and language assessment, using the FITness Assessment in Preschool Battery (PREFIT) and The National Institutes of Health Toolbox Early Childhood Cognition Battery. This project aims to improve cognitive and motor skills in preschoolers aged between 3 and 6 years old based on a 9-month Tele-SSE intervention. If this intervention proves to be effective, it could be implemented in those centres, entities and associations specialized in early childhood education.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112862 0
Prof José Carmelo Adsuar Sala
Address 112862 0
University of Extremadura, Avenida de la Universidad, s/n, 10003 Cáceres (Spain)
Country 112862 0
Spain
Phone 112862 0
+34 927 257460
Fax 112862 0
Email 112862 0
[email protected]
Contact person for public queries
Name 112863 0
Dr Jorge Carlos-Vivas
Address 112863 0
University of Extremadura, Avenida de la Universidad, s/n, 10003 Cáceres (Spain)
Country 112863 0
Spain
Phone 112863 0
+34 927 257460
Fax 112863 0
Email 112863 0
[email protected]
Contact person for scientific queries
Name 112864 0
Dr Sabina Barrios-Fernandez
Address 112864 0
University of Extremadura, Avenida de la Universidad, s/n, 10003 Cáceres (Spain)
Country 112864 0
Spain
Phone 112864 0
+34 927 257450
Fax 112864 0
Email 112864 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12629Ethical approval    382451-(Uploaded-21-07-2021-20-21-40)-Study-related document.pdf



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.