Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06145529
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-11-17
Brief Title:
Resistance Training Based on Gamification in Children Aged 10-12 Years Old During Physical Education
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Resistance Training Based on Gamification During Physical Education
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETRAGAM
Brief Summary:
For this investigation a total of 300 children grades 5 and 6 10-12 years of age from 6 randomly selected schools in Valencia Spain will be enrolled during 8 weeks in one of the experimental groups EG EG1 15 of RT Functional HIIT circuit program EG2 the same EG1 program but with a gamification approach or CG control group Outcomes will include age and sex maturity PA profile MF assessed using an ad hoc battery anthropometry and body composition weight height sitting height waist circumference and BMI as well as the enjoyment and motivation during physical education An interactive app in a digital device will be used for the gamification story the points registration with the personal childrens avatar and content learning by flipped classroom The hypothesis of the RETRAGAM study posits that children who participate in the gamified RT intervention will experience greater improvements in MF body composition motivation and enjoyment compared to those who carry out the same intervention without gamification as well as the control group CG Thus the primary aim of the RETRAGAM study is to examine the effectiveness of a school-based RT intervention on MF body composition motivation and enjoyment in children aged 10 to 12 years Additionally the study will compare the effects on the main outcomes among several intervention groups ie RT RT with gamification approach and the CG
Detailed Description:
Study design participants and selection criteria The RETRAGAM study is a randomized controlled trial conducted in public primary schools in Valencia Spain with approval from The Human Research Ethics Committee of the Universitat of Valencia Id UV-INV_ETICA-2681359 The study aims to investigate the impact of a resistance training intervention with and without gamification on children aged 10-12 years
To select the participating schools random schools from a total of 167 primary schools in Valencia will be contacted by phone to inquire about their compliance with the inclusion criteria Researchers will explain the studys main objectives and once 6 schools meeting all the requirements are identified they will be enrolled in the study Each school will then be randomly assigned to one of three groups EG1 EG2 or the CG Within each school one grade 5 and one grade 6 class will be randomly selected for the study Subsequently researchers will conduct a meeting with the school staff to discuss the studys main objectives and the intervention procedure
Among the three intervention schools selected one will implement a 15-minute RT circuit program EG1 n100 another will apply the same program but including gamification strategies EG2 n100 The remaining school will serve as the control group CG n100 In the intervention schools the first 15 minutes of PE lessons typically allocated for warm-up will be replaced by the RT circuit program In the CG school children will continue with their regular PE sessions
To determine the sample size for the study effect sizes for the primary outcome muscular fitness were estimated While the health benefits of muscular fitness are widely acknowledged there is a lack of consensus regarding the clinical significance of changes in MF in young people Based on a prior study Lubans et al 2016 an effect size d04 for MF is anticipated Accordingly a minimum sample of 162 children 54 per intervention group 3 groups is required to detect between-group changes in MF with a power of 80 and α005 To account for potential dropout in a school context up to 10 the recruitment target is 145 children However to ensure an ample number of participants 300 students will be recruited 100 per intervention group
Interventions
Considering that school-based RT interventions should be realistic adapted to the school timetable and focused on improve MF body composition enjoyment and motivation in primary school children 10-12 years aged the following four 8-week school-based interventions programs were chosen for this study
The two-interventions included in the RETRAGAM study have been designed by the researcher based on suggestions regarding the desirability of exercises to specifically develop MF following the RT guidelines for children and adolescents Faigenbaum et al 2009b Lloyd et al 2014 and considering previous developed interventions in the same range of age Villa-González et al 2022
EG1 15 min RT FunctionalHIIT circuit program High intensity interval training HIIT describes physical exercise characterized by short and intermittent efforts of vigorous activity interspersed with resting periods at passive or low-intensity exercises Amaro-Gahete et al 2018 During each FunctionalHIIT training the teacher will demonstrate performance movements and will give feedback to students considering the correct execution providing standardized verbal encouragement
Volume 10 minday three times per week at moderate to high intensity 7-10 in the Borgs CR-10 scale Borg 1990 a total of 30 minweek which will be the half than the minimum childrens PA recommended by the WHO 60 minweek at MVPA
Intensity Participants were familiarized with the Borgs CR-10 scale Borg 1990 before the start of the intervention During the study the children will instruct to follow the movements targeting firstly 6-7 and 9-10 at the end After each FunctionalHIIT training all students will rate their perceived exertion during exercise Although there are previous studies that control intensity using the Borg scale in children of these ages Chen et al 2017 Engel et al 2019 Moran et al 2019 some random students belong to all groups ie EG1 EG2 and CG will wear a heart rate monitor Polar Ignite 2 monitor to control different intensity parameters ie HR HRMax HRV
Frequency 3 times per week based on a previous intervention on FunctionalHIIT in children Engel et al 2019 and following the RT guidelines for children and adolescents Faigenbaum et al 2009b Stricker et al 2020 and the recommendations of the Resistance Training for Children Consensus Lloyd et al 2014
Type of exercise For the FunctionalHIIT program the participants will perform eight weight-bearing exercises in circuit format ie push-ups squats planks etc
Training load variation We consider that participants will not immediately meet the required intensity level Instead a gradual progression will be introduced to control the exercise dose Initially participants will start at an intensity level of 6-7 on the Borgs CR-10 scale and this will increase by 1 point every two weeks until reaching 9-10 out of 10 The training duration during the main portion will increase by 5 seconds every two weeks while the recovery interval between exercises will decrease from 3 seconds initially to 15 seconds at the end The exercises themselves will become progressively more challenging over the course of the training program and change every two weeks Furthermore considering individual characteristics the progression will be adapted for particularly inactive or overweight children allowing them to repeat exercises from the previous week
Training sessions Each training session will commence with a 3-minute dynamic standardized warm-up 3-6 RPE including muscle activation exercises such as skipping jumping jacks and jumps The 10-minute main part 7-10 RPE will involve participants performing eight exercises in pairs or trios in a circuit format with a focus on making as many repetitions as possible and targeting the previously indicated RPE levels The teacher along with the support of two selected students from the school will encourage and monitor the technique and effort during the circuit The training session will conclude with a 2-minute cooling-down 3-4 RPE that includes stretching exercises
EG2 15 min RT FunctionalHIIT circuit program with gamification The EG2 training part will develop following the same protocol described in EG1For the gamification experience students will embark on a superhero-themed narrative journey where they must train diligently to earn points and badges improving their avatars along the way The ultimate goal is to defeat a super villain in the final battle after 8 weeks The RETRAGAM study utilizes a self-created app accessible at httpsgoosuGVgSPW for the gamification story point tracking and personalization of childrens avatars As part of the flipped classroom approach children can access the platform to preview upcoming exercises and educational content ie benefits of RT knowledge of the muscles bones and joints involved in exercises postural habits etc To motivate students biweekly motivational videos related to the superhero narrative will be shared encouraging them to actively participate in the RT program At the end of each training day students will conduct self-evaluations earning 0-3 points based on their level of training engagement exercise technique RPE compliance and comradeship These points will be used to improve their individual avatars at the end of each week ie superhero attires equipment power etc At the end of the 8 weeks students will have to defeat the super villain at the final battle questionnaire on what has been learned and they will receive a physical badge that they can wear in their t-shirt at the retest measurement session Teacher will have a spreadsheet to record all the points that will complement the evaluation of the PE sessions Figure 1 summarises the EG2 intervention
CG Control group We will provide general advice to the CG participants though an information meeting that will indicated to maintain their lifestyle At the end of the intervention in order to comply with the ethical commitment PE teachers will be instructed on the RT programme and the RETRAGAM app to allow them to carry out the intervention autonomously when they consider
Data analysis All outcome variables will be verified for normality and the results will be presented using mean and standard deviation or median and interquartile range where appropriate for continuous variables and frequency and percentage for categorical variables We will use an analysis of covariance ANCOVA for between group comparisons at the baseline EG1 vs EG2 vs CG and the nonparametric method of Kruskal-Wallis and t-tests as appropriate
To assess the effectiveness of the different interventions on objectively measured MF and the other outcomes a multi-factor ANOVA time-point T0 T1 x group EG1 vs EG2 vs CG will be used with the outcome measures as dependent variables in separate models the intervention as an independent variable and controlling for potential confounders such as gender sociodemographic characteristics health status BMI PHV PA level and MF baseline Statistical significance will be set at p005
To select the participating schools random schools from a total of 167 primary schools in Valencia will be contacted by phone to inquire about their compliance with the inclusion criteria Researchers will explain the studys main objectives and once 6 schools meeting all the requirements are identified they will be enrolled in the study Each school will then be randomly assigned to one of three groups EG1 EG2 or the CG Within each school one grade 5 and one grade 6 class will be randomly selected for the study Subsequently researchers will conduct a meeting with the school staff to discuss the studys main objectives and the intervention procedure
Among the three intervention schools selected one will implement a 15-minute RT circuit program EG1 n100 another will apply the same program but including gamification strategies EG2 n100 The remaining school will serve as the control group CG n100 In the intervention schools the first 15 minutes of PE lessons typically allocated for warm-up will be replaced by the RT circuit program In the CG school children will continue with their regular PE sessions
To determine the sample size for the study effect sizes for the primary outcome muscular fitness were estimated While the health benefits of muscular fitness are widely acknowledged there is a lack of consensus regarding the clinical significance of changes in MF in young people Based on a prior study Lubans et al 2016 an effect size d04 for MF is anticipated Accordingly a minimum sample of 162 children 54 per intervention group 3 groups is required to detect between-group changes in MF with a power of 80 and α005 To account for potential dropout in a school context up to 10 the recruitment target is 145 children However to ensure an ample number of participants 300 students will be recruited 100 per intervention group
Interventions
Considering that school-based RT interventions should be realistic adapted to the school timetable and focused on improve MF body composition enjoyment and motivation in primary school children 10-12 years aged the following four 8-week school-based interventions programs were chosen for this study
The two-interventions included in the RETRAGAM study have been designed by the researcher based on suggestions regarding the desirability of exercises to specifically develop MF following the RT guidelines for children and adolescents Faigenbaum et al 2009b Lloyd et al 2014 and considering previous developed interventions in the same range of age Villa-González et al 2022
EG1 15 min RT FunctionalHIIT circuit program High intensity interval training HIIT describes physical exercise characterized by short and intermittent efforts of vigorous activity interspersed with resting periods at passive or low-intensity exercises Amaro-Gahete et al 2018 During each FunctionalHIIT training the teacher will demonstrate performance movements and will give feedback to students considering the correct execution providing standardized verbal encouragement
Volume 10 minday three times per week at moderate to high intensity 7-10 in the Borgs CR-10 scale Borg 1990 a total of 30 minweek which will be the half than the minimum childrens PA recommended by the WHO 60 minweek at MVPA
Intensity Participants were familiarized with the Borgs CR-10 scale Borg 1990 before the start of the intervention During the study the children will instruct to follow the movements targeting firstly 6-7 and 9-10 at the end After each FunctionalHIIT training all students will rate their perceived exertion during exercise Although there are previous studies that control intensity using the Borg scale in children of these ages Chen et al 2017 Engel et al 2019 Moran et al 2019 some random students belong to all groups ie EG1 EG2 and CG will wear a heart rate monitor Polar Ignite 2 monitor to control different intensity parameters ie HR HRMax HRV
Frequency 3 times per week based on a previous intervention on FunctionalHIIT in children Engel et al 2019 and following the RT guidelines for children and adolescents Faigenbaum et al 2009b Stricker et al 2020 and the recommendations of the Resistance Training for Children Consensus Lloyd et al 2014
Type of exercise For the FunctionalHIIT program the participants will perform eight weight-bearing exercises in circuit format ie push-ups squats planks etc
Training load variation We consider that participants will not immediately meet the required intensity level Instead a gradual progression will be introduced to control the exercise dose Initially participants will start at an intensity level of 6-7 on the Borgs CR-10 scale and this will increase by 1 point every two weeks until reaching 9-10 out of 10 The training duration during the main portion will increase by 5 seconds every two weeks while the recovery interval between exercises will decrease from 3 seconds initially to 15 seconds at the end The exercises themselves will become progressively more challenging over the course of the training program and change every two weeks Furthermore considering individual characteristics the progression will be adapted for particularly inactive or overweight children allowing them to repeat exercises from the previous week
Training sessions Each training session will commence with a 3-minute dynamic standardized warm-up 3-6 RPE including muscle activation exercises such as skipping jumping jacks and jumps The 10-minute main part 7-10 RPE will involve participants performing eight exercises in pairs or trios in a circuit format with a focus on making as many repetitions as possible and targeting the previously indicated RPE levels The teacher along with the support of two selected students from the school will encourage and monitor the technique and effort during the circuit The training session will conclude with a 2-minute cooling-down 3-4 RPE that includes stretching exercises
EG2 15 min RT FunctionalHIIT circuit program with gamification The EG2 training part will develop following the same protocol described in EG1For the gamification experience students will embark on a superhero-themed narrative journey where they must train diligently to earn points and badges improving their avatars along the way The ultimate goal is to defeat a super villain in the final battle after 8 weeks The RETRAGAM study utilizes a self-created app accessible at httpsgoosuGVgSPW for the gamification story point tracking and personalization of childrens avatars As part of the flipped classroom approach children can access the platform to preview upcoming exercises and educational content ie benefits of RT knowledge of the muscles bones and joints involved in exercises postural habits etc To motivate students biweekly motivational videos related to the superhero narrative will be shared encouraging them to actively participate in the RT program At the end of each training day students will conduct self-evaluations earning 0-3 points based on their level of training engagement exercise technique RPE compliance and comradeship These points will be used to improve their individual avatars at the end of each week ie superhero attires equipment power etc At the end of the 8 weeks students will have to defeat the super villain at the final battle questionnaire on what has been learned and they will receive a physical badge that they can wear in their t-shirt at the retest measurement session Teacher will have a spreadsheet to record all the points that will complement the evaluation of the PE sessions Figure 1 summarises the EG2 intervention
CG Control group We will provide general advice to the CG participants though an information meeting that will indicated to maintain their lifestyle At the end of the intervention in order to comply with the ethical commitment PE teachers will be instructed on the RT programme and the RETRAGAM app to allow them to carry out the intervention autonomously when they consider
Data analysis All outcome variables will be verified for normality and the results will be presented using mean and standard deviation or median and interquartile range where appropriate for continuous variables and frequency and percentage for categorical variables We will use an analysis of covariance ANCOVA for between group comparisons at the baseline EG1 vs EG2 vs CG and the nonparametric method of Kruskal-Wallis and t-tests as appropriate
To assess the effectiveness of the different interventions on objectively measured MF and the other outcomes a multi-factor ANOVA time-point T0 T1 x group EG1 vs EG2 vs CG will be used with the outcome measures as dependent variables in separate models the intervention as an independent variable and controlling for potential confounders such as gender sociodemographic characteristics health status BMI PHV PA level and MF baseline Statistical significance will be set at p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None