Intervention With Alternative Sports for Physical and Mental Improvement in Primary School Children

NCT ID: NCT07313267

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-01

Study Completion Date

2026-09-12

Brief Summary

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The objective of this clinical trial is to determine whether a school-based intervention involving alternative sports can improve physical fitness, motor skills, and psychological well-being in elementary school students. The main question to be answered is:

Can participating in a physical intervention involving alternative sports help children improve their strength, speed, endurance, motor skills, and enjoyment of physical activity? For 8 weeks, during physical education classes, researchers will compare an intervention with alternative sports (korfball, flag football, kin-ball, and ultimate frisbee) with the usual classes that students receive according to their study program, to see if alternative sports improve physical and psychological aspects.

Participants must:

* Perform physical and motor tests to determine their initial physical condition
* Complete a questionnaire to determine their level of enjoyment during physical activity.
* Actively participate in an 8-week intervention during physical education classes.
* Monitor their level of physical activity during classes using a device (accelerometer).
* Authorize the use of their first semester grades.
* At the end of the intervention, physical and motor tests will be performed again to assess progress and physical changes.

For eight weeks, researchers will conduct a study in physical education classes to compare two types of teaching: one based on alternative sports (such as korfball, flag football, kin-ball, and ultimate frisbee) and another with traditional school program classes to see if children improve physically and psychologically.

Detailed Description

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The RENUEVATE study is a randomized controlled cluster trial with a parallel group design and repeated measurements, developed using a quantitative approach. The study follows the CONSORT guidelines for randomized cluster trials and has been approved by the Scientific Ethics Committee of the Catholic University of Maule, Chile (Resolution No. 112/2025). All procedures comply with the principles of the Declaration of Helsinki.

Randomization is performed at the educational establishment level in order to reduce the risk of contamination between participants. Three urban establishments in the city of Talca, Chile, representative of different administrative and socioeconomic contexts (municipal and privately subsidized), are randomly assigned to the intervention group (IG) or control group (CG). In each establishment, one sixth-grade class is assigned to the IG and another to the CG, making a total of six clusters.

Participants in the intervention group receive the RENUEVATE program, a school physical activity intervention integrated into regular physical education classes. The program is implemented during the academic period by previously trained physical education teachers, using a standardized manual that ensures the fidelity of the intervention. Teachers receive initial training and periodic supervision from the research team.

The intervention is based on the use of alternative sports (flag football, ultimate frisbee, korfball, and kin-ball), selected for their ability to promote moderate to vigorous physical activity, motor skill development, cooperation, inclusion, and gender equality. Each session follows a standardized structure that includes warm-up, main development, and cool-down phases, prescribing the intensity necessary to achieve adequate levels of physical effort during the central phase. The fidelity and dose of the intervention are monitored through session records, subjective perception of effort, and heart rate monitoring in a subsample of participants.

The control group continues with the regular physical education curriculum taught by the school, without modifications or exposure to the intervention content, participating only in pre- and post-intervention assessments.

Assessments are conducted at two points in time: before the start of the intervention (baseline) and at the end of the program, during the school day and by previously trained assessors, ideally blinded to group assignment. Primary and secondary outcomes include variables of physical fitness, motor skills, physical activity levels, body composition, enjoyment of physical activity, and health-related quality of life, assessed using validated instruments widely used in children. A detailed description of the variables and measurement instruments is presented in the corresponding sections of the registry.

The sample size was estimated to detect a clinically relevant difference in the percentage of body fat between groups, considering the cluster design and an expected intraclass correlation. Statistical analysis will be performed under the intention-to-treat principle, using mixed-effects models that allow for the hierarchical structure of the data and repeated measurements over time, adjusting for baseline values and relevant covariates. The procedures for handling missing data and sensitivity analyses are predefined in the study protocol.

Conditions

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Primary School Students Healthy

Keywords

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physical fitness motor skills children physical interventions alternative sports

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The trial is designed as a cluster-randomized trial with randomization units: course groups. The minimum clinically relevant difference in body fat percentage has been defined as 3 percentage points (Δ = 3), with an estimated standard deviation of 5. A significance level of α = 0.05 (two-tailed) and statistical power of 80% were assumed. An average cluster size of n = 35 students and a loss/adherence rate of 15% were considered. Based on recent literature on CRTs in school children, an intracluster correlation coefficient (ICC) = 0.03 was assumed.

With these assumptions, ≈ 44 students per arm are needed in an individual trial. Adjusting for cluster effect with ICC = 0.03, the size per arm increases to ≈ 88 students. Then, considering 15% losses, the final size per arm is ≈ 104 students. To cover this with average group sizes of 35, 3 courses/clusters per arm (6 clusters in total) will be needed, implying 210 enrolled students (105 intervention / 105 control)
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention with alternative sports

The experimental group will hold 90-minute sessions twice a week for two months. Each two-week block will be dedicated to an alternative sport (flag football, ultimate frisbee, korfball, and kin-ball).

Group Type EXPERIMENTAL

Intervention with Alternative Sports (kin-ball, korfball, ultimate frisbee and flag football))

Intervention Type OTHER

The RENUÉVATE intervention will be implemented by previously trained physical education teachers. It will last for two months, with sessions held twice a week. The sessions will take place during the school day, in physical education classes, and will last 90 minutes. Each two-week block will be dedicated to an alternative team sport (flag football, ultimate frisbee, korfball, and kin-ball). The physical load for each session is as follows:

Warm-up (15 min): general mobility and specific exercises to prepare for the sport in question, maintaining an intensity of 50-60% HRmax; RPE 9-11.

Main part (65 min): practice of the alternative sport through games and technical/tactical progressions. An intensity of 65-80% HRmax will be prescribed; RPE 12-15, with active breaks between tasks.

Cool down (10 min): relaxation, stretching, and group reflection activities with a light intensity \<50% HRmax; RPE ≤ 9.

Control Group, traditional classes.

The control group (CG) will only participate in the initial and final evaluations, continuing with their traditional physical education classes without modifications, distributed in two weekly sessions of 90 minutes each.

The classes incorporate sports and motor activities that involve collaborative sports and games.

Group Type ACTIVE_COMPARATOR

Intervention with regular classes from the school curriculum

Intervention Type OTHER

The intervention will be implemented by physical education teachers who have been trained in the project's objectives, methodology, and values. The training will include a standardized manual and a two-hour weekly practical session to ensure fidelity in the program's implementation. In addition, weekly monitoring meetings will be held with the research team to resolve questions and ensure consistency across schools.

Interventions

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Intervention with Alternative Sports (kin-ball, korfball, ultimate frisbee and flag football))

The RENUÉVATE intervention will be implemented by previously trained physical education teachers. It will last for two months, with sessions held twice a week. The sessions will take place during the school day, in physical education classes, and will last 90 minutes. Each two-week block will be dedicated to an alternative team sport (flag football, ultimate frisbee, korfball, and kin-ball). The physical load for each session is as follows:

Warm-up (15 min): general mobility and specific exercises to prepare for the sport in question, maintaining an intensity of 50-60% HRmax; RPE 9-11.

Main part (65 min): practice of the alternative sport through games and technical/tactical progressions. An intensity of 65-80% HRmax will be prescribed; RPE 12-15, with active breaks between tasks.

Cool down (10 min): relaxation, stretching, and group reflection activities with a light intensity \<50% HRmax; RPE ≤ 9.

Intervention Type OTHER

Intervention with regular classes from the school curriculum

The intervention will be implemented by physical education teachers who have been trained in the project's objectives, methodology, and values. The training will include a standardized manual and a two-hour weekly practical session to ensure fidelity in the program's implementation. In addition, weekly monitoring meetings will be held with the research team to resolve questions and ensure consistency across schools.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Be enrolled in the assigned school.
* Have no motor problems that prevent participation in the physical activities proposed for the development of alternative sports.

Exclusion Criteria

* Not having taken the initial or final tests.
Minimum Eligible Age

11 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica del Maule

OTHER

Sponsor Role lead

Responsible Party

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María P. Pezoa Fuentes

Doctor of Physical Activity Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eugenio N Merellano Navarro, Doctor

Role: STUDY_DIRECTOR

Universidad Católica del Maule

Locations

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Universidad Católica del Maule

Talca, Maule Region, Chile

Site Status

Countries

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Chile

Central Contacts

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María P Pezoa Fuentes, Doctor

Role: CONTACT

Phone: +56988816597

Email: [email protected]

Eugenio N Merellano Navarro, Doctor

Role: CONTACT

Phone: +56982307921

Email: [email protected]

References

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Reference Type RESULT

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Reference Type RESULT

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Reference Type RESULT
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Migueles, J. H., Rowlands, A. V., Huber, F., Sabia, S., & Van Hees, V. T. GGIR: A Research Community-Driven Open Source R Package for Generating Physical Activity and Sleep Outcomes From Multi-Day Raw Accelerometer Data. Journal for the Measurement of Physical Behaviour, 2019. 2(3), 188-196. https://doi.org/10.1123/jmpb.2018-0063

Reference Type RESULT

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Reference Type RESULT

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Other Identifiers

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UCM-IN-25214

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UCM-IN-25214

Identifier Type: -

Identifier Source: org_study_id