NCT07313267

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

December 3, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

December 3, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

physical fitnessmotor skillschildrenphysical interventionsalternative sports

Outcome Measures

Primary Outcomes (5)

  • Motor competence

    It will be assessed using the Motorishe Basiskompetenzen (MOBAK) battery, which evaluates body control (balance, rolling, jumping) and object control (throwing, catching, bouncing, dribbling), used in schoolchildren aged 10 to 12. For throwing and catching tasks, children have 6 attempts (no trial attempts), in which the number of successes, i.e., successful attempts, is recorded. These are then scored: 0 to 2 successes, 0 points; 3 to 4 successes, 1 point; and 5 to 6 successes, 2 points. For the tasks of driving with the hand, driving with the foot, balancing, rolling, jumping, and running. Children have 2 attempts to complete the task (no trial attempts). The scoring of these tests is based on a dichotomous scale (0 = not achieved, 1 = achieved), in which the number of successful attempts is recorded (never achieved = 0 points; achieved once = 1 point; achieved twice = 2 points). The score from 0 to 8 determines the level of basic motor skills in a differentiated manner.

    It will be evaluated on day 1 (pre-test) and day 16 (post-test).

  • Cardiorespiratory capacity

    Cardiorespiratory capacity will be assessed, using tests that have been widely validated in school populations: For cardiorespiratory capacity, a 6-minute walk test will be used to estimate VO₂max.

    A measurement will be taken at the start of the intervention on day 1 (pre-test) and another assessment will be carried out at the end of the intervention on day 16 (post-test).

  • Muscle strength (Lower Limb )

    Lower limb muscle strength will be assessed using tests that have been widely validated in school populations: the Bosco Test (squat jump (SJ) and counter-movement jump (CMJ) on a force platform.

    A measurement will be taken at the start of the intervention on day 1 (pre-test) and another assessment will be carried out at the end of the intervention on day 16 (post-test).

  • Muscle Strength (Upper Limb)

    Grip strength will be assessed using a Camry EH101 hydraulic dynamometer, which is known for its high accuracy.

    A measurement will be taken at the start of the intervention, on Day 1 (pre-test), and another assessment will be conducted at the end of the intervention, on Day 16 (post-test).

  • Enjoyment

    Enjoyment of physical activity was assessed using the Spanish version of the Physical Activity Enjoyment Scale (PACES). This scale consists of 16 items. Responses were collected on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree). The score is obtained by calculating the average of the 16 items. The total score ranges from 16 to 80, with higher values indicating greater enjoyment.

    It will be evaluated on day 1 (pre-test) and day 16 (post-test).

Secondary Outcomes (8)

  • Body Composition (Bioelectrical Impedance Analysis)

    It will be evaluated on day 1 (pre-test) and day 16 (post-test)

  • Morphological variables (Body Height)

    It will be evaluated on day 1 (pre-test) and day 16 (post-test).

  • Morphological variables (Body Weight)

    It will be evaluated on day 1 (pre-test) and day 16 (post-test).

  • Morphological variables (Body Mass Index)

    It will be evaluated on day 1 (pre-test) and day 16 (post-test).

  • Morphological variables (Waist Circumference)

    It will be evaluated on day 1 (pre-test) and day 16 (post-test).

  • +3 more secondary outcomes

Other Outcomes (1)

  • Sociodemographic Characteristics (Covariates)

    It will be evaluated on day 1 (pre-test) and day 16 (post-test).

Study Arms (2)

Intervention with alternative sports

EXPERIMENTAL

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).

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

Control Group, traditional classes.

ACTIVE COMPARATOR

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.

Other: Intervention with regular classes from the school curriculum

Interventions

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 with alternative sports

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.

Control Group, traditional classes.

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Not having taken the initial or final tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica del Maule

Talca, Maule Region, 3460000, Chile

Location

Related Publications (15)

  • Zurita-Ortega, F., Ubago-Jiménez, J. L., Ibáñez, E. M., González-Valero, G., & Alonso Vargas, J. M. Effects of a physical education programme based on kin ball on body mass index and basic physical skills in students with down syndrome. (2025). https://doi.org/10.12800/ccd.v20i63.2211

    RESULT
  • Vaquero-Solís, M., Tapia-Serrano, M. A., Moreno-Díaz, M. I., Cerro-Herrero, D., & Sánchez-Miguel, P. A. Exploratory analysis of physical activity in self-objectification and body image of adolescents. Cultura, Ciencia y Deporte, (2021). 16(48), 199-206. https://doi.org/10.12800/CCD.V16I48.1724

    RESULT
  • Stewart, A., Marfell-Jones, M., Olds, T., & de Ridder, J. International Standards for Anthropometric Assessment. (2011). ISAK.

    RESULT
  • Muñoz Troncoso, F., Becerra Peña, S., & Riquelme, E. Elaboración y validación psicométrica del cuestionario de convivencia escolar para la no violencia (CENVI). Estudios Pedagógicos (Valdivia), (2017). 43(3), 205-223. https://doi.org/10.4067/S0718-07052017000300012

    RESULT
  • Moya-Mata, I., Ruiz-Sanchis, L., Martín-Ruiz, J., & Ros-Ros, C. Physical activity represented in physical education textbooks for elementary education. Movimento, (2019). 25(1). https://doi.org/10.22456/1982-8918.89296

    RESULT
  • Morales-Campo PT, Perez-Munoz S, Lopez-Garcia S, Diez-Fernandez P, Rodriguez-Cayetano A. New alternative proposal in physical education: Touchtennis as a racket sport in schools. Front Sports Act Living. 2025 Mar 3;7:1545994. doi: 10.3389/fspor.2025.1545994. eCollection 2025.

  • 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

    RESULT
  • Martins S, Augusto C, Martins MRO, Jose Silva M, Okan O, Dadaczynski K, Duarte A, Fronteira I, Ramos N, Rosario R. Adaptation and validation of the Digital Health Literacy Instrument for Portuguese university students. Health Promot J Austr. 2022 Oct;33 Suppl 1:390-398. doi: 10.1002/hpja.580. Epub 2022 Feb 17.

  • Markovic J, Bubanj S, Sekeljic G, Pavlovic S, Radenkovic M, Stankovic D, Petkovic E, Aksovic N, Radenkovic O, Preljevic A, Bjelica B, Petrovic V, Sinanovic S, Tomovic M. Efficiency of an Alternative Physical Education Program for the Lower Grades of Elementary School Children. Children (Basel). 2023 Oct 6;10(10):1657. doi: 10.3390/children10101657.

  • Marfell-Jones, M. J., Stewart, A., & de Ridder, J. H. International standards for anthropometric assessment. (2012). International Society for the Advancement of Kinanthropometry.

    RESULT
  • Leuschner M, Grauduszus M, Friesen D, Ferrari N, Klaudius M, Joisten C. The 6-minute Run Test: Validation and Reference Equations for Adults. Int J Sports Med. 2024 Mar;45(3):222-230. doi: 10.1055/a-2206-5291. Epub 2023 Dec 19.

  • Lettink A, Altenburg TM, Arts J, van Hees VT, Chinapaw MJM. Systematic review of accelerometer-based methods for 24-h physical behavior assessment in young children (0-5 years old). Int J Behav Nutr Phys Act. 2022 Sep 8;19(1):116. doi: 10.1186/s12966-022-01296-y.

  • Herrmann, C. MOBAK 1-4. Test zur Erfassung Motorischer Basiskompetenzen für die Klassen 1-4 (2018). Hogrefe.

    RESULT
  • Chen C, Weyland S, Fritsch J, Woll A, Niessner C, Burchartz A, Schmidt SCE, Jekauc D. A Short Version of the Physical Activity Enjoyment Scale: Development and Psychometric Properties. Int J Environ Res Public Health. 2021 Oct 20;18(21):11035. doi: 10.3390/ijerph182111035.

  • Budler LC, Pajnkihar M, Ravens-Sieberer U, Barr O, Stiglic G. The KIDSCREEN-27 scale: translation and validation study of the Slovenian version. Health Qual Life Outcomes. 2022 Apr 21;20(1):67. doi: 10.1186/s12955-022-01973-3.

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Eugenio N Merellano Navarro, Doctor

    Universidad Católica del Maule

    STUDY DIRECTOR

Central Study Contacts

María P Pezoa Fuentes, Doctor

CONTACT

Eugenio N Merellano Navarro, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Physical Activity Sciences

Study Record Dates

First Submitted

December 3, 2025

First Posted

December 31, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 12, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Yes, inpatient data will be shared, specifically the data supporting the results of the publication. Study participants will be assigned a code, and that data will be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
Individual patient data will be available from July 2026 to December 2026.
Access Criteria
* The criteria that must be met for data to be shared. * The study design must be experimental, using a controlled trial. * The intervention group must be between 10 and 12 years old. * Statistical methods will be analyzed using mixed linear models, considering the fixed effect of the group (GI vs. GC), baseline, age, and sex, and including a random effect by school cluster to adjust for intraclass correlation. * The mechanism for sharing data is to submit a written request by email, indicating the reasons for the data request, providing a summary of the project, and disclosing the statistical analysis to be performed. * Once the document has been reviewed and approved by the principal investigator, a data exchange agreement will be signed.

Locations