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临床试验/NCT06145529
NCT06145529尚未招募不适用

Resistance Training Based on Gamification During Physical Education

University of Valencia1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
1
主要终点
Muscular fitness (MF)

研究概览

简要总结

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 point's registration with the personal children's 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 (i.e., RT, RT with gamification approach and the CG).

详细描述

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 study's 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 study's main objectives and the intervention procedure.

Among the three intervention schools selected, one will implement a 15-minute RT circuit program (EG1, n≃100), another will apply the same program but including gamification strategies (EG2, n≃100). The remaining school will serve as the control group (CG, n≃100). 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 d=0.4 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 α=0.05. 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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

年龄范围
9 Years 至 13 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •As this is a school-based intervention study, the inclusion criteria are for the school itself. They are as follows:
  • •1 class of grade 5 and other of grade 6 in the school.
  • •At least 20 children class size.
  • •Includes 45 min PE sessions three times per week in both grades.
  • •They cannot develop physical condition didactic unite at the same time.

排除标准

  • •Exclusion criteria include participants who have diagnosed medical problems that prevent them from participating in the intervention.

研究组 & 干预措施

EG1: 15 min RT (FunctionalHIIT) circuit program

Experimental

Volume: ≃10 min/day three times per week at moderate to high intensity (7-10 RPE). Intensity: During the study the children will instruct to follow the movements targeting firstly 6-7 and 9-10 at the end. Frequency: 3 times per week. Type of exercise: For the FunctionalHIIT program the participants will perform eight weight-bearing exercises in circuit format (i.e., push-ups, squats, planks, etc.). Training load variation: Initially, participants will start at an intensity level of 6-7 on the Borg's 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. The exercises themselves will become progressively more challenging over the course of the training program and change every two weeks.

干预措施: RT Functional HIIT circuit program (15 minutes) with or without gamification approach (Other)

EG2: 15 min RT (FunctionalHIIT) circuit program with gamification

Experimental

The EG2 training part will develop following the same protocol described in EG1.For 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 https://goo.su/GVgSPW) for the gamification story, point tracking, and personalization of children's avatars. As part of the flipped classroom approach, children can access the platform to preview upcoming exercises and educational content (i.e., benefits of RT, knowledge of the muscles, bones and joints involved in exercises, postural habits, etc.).

干预措施: RT Functional HIIT circuit program (15 minutes) with or without gamification approach (Other)

CG (Control group)

No Intervention

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.

结局指标

主要结局

Muscular fitness (MF)

时间窗: this outcome will be assessed twice: a pre-test two weeks before the 8-week intervention and a post-test one week after the intervention.

MF will be assessed using a battery of children strength designed ad hoc for this investigation. This battery comprises 8 tests that assess the 3 dimensions of MF: strength, power, and endurance. These tests encompass upper limbs (handgrip, push-up test, and medicinal ball throwing), lower limbs (single-hop test, two-legged squat test, and standing long jump), and trunk strength (curl-up test and sport-specific endurance plank test). Before the fitness assessments, all participants will engage in a 5-minute dynamic standardized warm-up, involving exercises that activate the muscles and improve joint mobility, such as limb mobility exercises, skipping, jumping jacks, and jumps.

次要结局

  • Physical Activity Profile(this outcome will be assessed twice: a pre-test two weeks before the 8-week intervention and a post-test one week after the intervention.)
  • Maturity(this outcome will be assessed twice: a pre-test two weeks before the 8-week intervention and a post-test one week after the intervention.)
  • Anthropometric Data and Body Composition(this outcome will be assessed twice: a pre-test two weeks before the 8-week intervention and a post-test one week after the intervention.)
  • Sociodemographic characteristics and health status(this outcome will be assessed twice: a pre-test two weeks before the 8-week intervention and a post-test one week after the intervention.)
  • Enjoyment and motivation(this outcome will be assessed twice: a pre-test two weeks before the 8-week intervention and a post-test one week after the intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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