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Clinical Trials/NCT07313267
NCT07313267
Not yet recruiting
Not Applicable

Effectiveness of an Intervention Programme Using Alternative Sports for the Recovery of Motor Learning and the Improvement of Physical and Mental Health in Primary School Students.

Universidad Católica del Maule2 sites in 1 country210 target enrollmentStarted: April 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
210
Locations
2
Primary Endpoint
Cardiorespiratory capacity

Overview

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
11 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • The inclusion criteria for participants are as follows:
  • Be enrolled in the assigned school.
  • Have no motor problems that prevent participation in the physical activities proposed for the development of alternative sports.
  • Have completed ≥ 85% of the sessions. The

Exclusion Criteria

  • Not having taken the initial or final tests.

Arms & Interventions

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).

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

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.

Intervention: Intervention with regular classes from the school curriculum (Other)

Outcomes

Primary Outcomes

Cardiorespiratory capacity

Time Frame: 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).

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.

Muscle strength (Lower Limb )

Time Frame: 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).

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.

Muscle Strength (Upper Limb)

Time Frame: 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).

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

Motor competence

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

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.

Physical fitness

Time Frame: 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).

Physical fitness 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; Lower limb muscle strength will be assessed using the squat jump (SJ) and counter-movement jump (CMJ) on a force platform, and handgrip strength will be assessed using a Camry EH101 hydraulic dynamometer, recognized for its high reliability.

Enjoyment

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

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.

Secondary Outcomes

  • Morphological variables (Body Weight)(It will be evaluated on day 1 (pre-test) and day 16 (post-test).)
  • 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 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).)
  • Physical activity level (objective)(It will be evaluated on day 1 (pre-test) and day 16 (post-test))
  • Level of physical activity (self-reported)(It will be measured on day 1 (pre-test) and day 16 (post-test).)
  • Health-related quality of life(It will be evaluated on day 1 (pre-test) and day 16 (post-test).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

María P. Pezoa Fuentes

Doctor of Physical Activity Sciences

Universidad Católica del Maule

Study Sites (2)

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