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Clinical Trials/NCT05243784
NCT05243784
Completed
Not Applicable

The Impact of a Classroom-based Physical Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschool Children. A Pilot Trial Study (MOVI- HIIT)

University of Castilla-La Mancha1 site in 1 country62 target enrollmentJanuary 27, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Activity
Sponsor
University of Castilla-La Mancha
Enrollment
62
Locations
1
Primary Endpoint
Evaluation of the perceived effort and exercise enjoyment within the use of the MOVI-HIIT platform by questionnaires.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Pilot study to test the acceptability and feasibility of an intervention aimed to test the effectiveness, in preschool children, of an integrated physical activity intervention in the classroom based on intervallic training (MOVI-HIIT) on improving executive function, body composition and cardiorespiratory fitness.

Detailed Description

The evolution of the MOVI studies, conducted by the research group, has led to create the last project (MOVI-HIIT; ClinicalTrials.gov Identifier: NCT04863040). This pilot study will include children aged 4-6 years from 2 public schools of the province of Ciudad Real, Spain, with 2 arms (intervention and control) and the intervention will last 8 weeks. The intervention proposed in the study is implemented through an online platform developed to achieved the intensities required for the age-range of participants, but this platform has never been tested accurately in the classroom. Thus, it seems necessary to pilot the intervention to evaluate the acceptability and feasibility of the intervention, in order to improve facts, if necessary, to achieved proposed objectives.

Registry
clinicaltrials.gov
Start Date
January 27, 2022
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Castilla-La Mancha
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The participating schoolchildren must belong to the 2nd and 3rd year of preschool education, not have any malformation that prevents them from learning the Spanish language (or Spanish sign language), not have any type of physical or mental disorder that parents and/or teachers have identified that prevents the performance of physical activities, not suffer from any chronic disease such as heart disease, diabetes or asthma that, according to the criteria of their pediatrician - after analysis of the program of activities - prevents their participation in the measurements and/or the intervention.
  • As this is an intervention in the classroom, the school faculty will include the active breaks proposed in the center's programming, for which reason the intervention will be received by all the children in the intervention group school. However, the investigators will consider school participants to be those who have the consent of the parent or guardian for participation in the study. In addition, schoolchildren must verbally express their willingness to participate in the baseline and final physical examinations.

Exclusion Criteria

  • Children with severe Spanish language learning difficulties.
  • Children with serious physical or mental disorders identified by parents or teachers that would impede participation in the programme's activities.
  • Children diagnoses of chronic disorders, such as heart disease, diabetes or asthma, which in the opinion of their paediatricians would prevent their participation in the programme's activities (MOVI-HIIT)

Outcomes

Primary Outcomes

Evaluation of the perceived effort and exercise enjoyment within the use of the MOVI-HIIT platform by questionnaires.

Time Frame: 4 months

The schoolchildren's exercise enjoyment will be measured with the short version of the Physical Activity Enjoyment Scale, PACES-S \[10.3390/ijerph182111035\]), (range from 4 to 12, where the highest rate indicates more satisfaction); and the schoolchildren's perceived effort will be assessed with the Children's Effort Rating Table, Pictorial-CERT \[10.1111/j.1365-2214.2007.00767.x.\], with a range from 1 to 10 (where 10 indicates the highest perceived effort).

Acceptance rate and adverse effects of the MOVI-HIIT intervention.

Time Frame: 4 months

The acceptability of the exercise program will be assessed recording adherence (rate of school's session attendance recorded in the online platform) and safety of the exercise programme (number and type of adverse events recorded by the teacher everyday after the session).

Participant's satisfaction with the MOVI-HIIT program by questionnaire

Time Frame: 4 months

An ad-hoc questionnarie will ask participants' about their satisfaction with the program (5-item pictorial scale questions, where the higher rate indicates higher satisfaction).

Evaluation of schoolchildren's compliance with the MOVI-HIIT intervention.

Time Frame: 4 months

These trial feasibility outcomes will include: (1) recruitment (percentage achieved of the targeted study sample), (2) retention (drop-out rate and reasons for withdrawal), (3) outcome completion (percentage of children with both measurements at the end of the study).

Teacher's perception about the suitability of the MOVI-HIIT platform by interviews.

Time Frame: 4 months

It will be assessed with teachers feedback via interviews on the use of the exercise platform (user-friendliness, connectivity, attractiveness, practicality) and the barriers and facilitators to implementing the programme.

Secondary Outcomes

  • Working memory (Executive Function)(4 months)
  • Inhibition/Attention (Executive Function)(4 months)
  • Percentage of body fat(4 months)
  • Children's active commuting to school questionnaire(4 months)
  • Cognitive flexibility (Executive Function)(4 months)
  • Health Related Quality of Life for children and parents(4 months)
  • Amount of daily performed physical activity(4 months)
  • VO2max(4 months)
  • The acute effect of physical exercise on the brain's electrical activity(4 months)

Study Sites (1)

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