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NCT Number: NCT07313267

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

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.

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Key information

Conditions

Primary School Students Healthy

Age range

11 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica del Maule

Talca, Maule Region, 3460000, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Intervention with regular classes from the school curriculum

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  1. Body Composition (Bioelectrical Impedance Analysis)

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

    Name of the measure: Body fat percentage Description: Body composition will be assessed using eight-electrode tetrapolar bioelectrical impedance analysis with the InBody 570® device. The outcome corresponds to body fat percentage obtained according to the manufacturer's standardized measurement protocol.

    Unit of measure: Percentage (%) Range: 0 to 100 percent. Direction of outcome: Lower values indicate a better outcome.

  2. Morphological variables (Body Height)

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

    Name of the measure: Body height Description: Body height measured following ISAK standardized protocols by an ISAK Level II anthropometrist.

    Unit of measure: Meters (m) Range: No predefined minimum or maximum values. Direction of outcome: Not applicable (descriptive anthropometric measure).

  3. Morphological variables (Body Weight)

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

    Name of the measure: Body weight Description: Body weight measured according to the International Society for the Advancement of Kinanthropometry (ISAK) standardized protocols by an ISAK Level II anthropometrist.

    Unit of measure: Kilograms (kg) Range: No predefined minimum or maximum values. Direction of outcome: Not applicable (descriptive anthropometric measure).

  4. Morphological variables (Body Mass Index)

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

    Name of the measure: Body Mass Index Description: Body Mass Index calculated as body weight in kilograms divided by height in meters squared (kg/m²), using measurements obtained according to ISAK standardized protocols by an ISAK Level II anthropometrist.

    Unit of measure: Kilograms per square meter (kg/m²) Range: No predefined minimum or maximum values. Direction of outcome: Lower values indicate a more favorable body composition.

  5. Morphological variables (Waist Circumference)

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

    Name of the measure: Waist circumference Description: Waist circumference measured according to ISAK standardized protocols by an ISAK Level II anthropometrist.

    Unit of measure: Centimeters (cm) Range: No predefined minimum or maximum values. Direction of outcome: Lower values indicate a more favorable central adiposity profile.

  6. Physical activity level (objective)

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

    Name of the measure: Moderate-to-vigorous physical activity Description: Physical activity level will be objectively assessed using ActiGraph wGT3X-BT triaxial accelerometers. Data will be processed using ActiLife software and the GGIR package in R. Time spent in moderate-to-vigorous physical activity will be calculated using validated pediatric cut-off points. The outcome corresponds to the average daily minutes of moderate-to-vigorous physical activity.

    Unit of measure: Minutes per day (min/day) Range: 0 to no predefined maximum value. Direction of outcome: Higher values indicate a better outcome (higher physical activity level).

  7. Level of physical activity (self-reported)

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

    This will be assessed using the Physical Activity Questionnaire for Adolescents (PAQ-A).

    Description of the scale:

    The Physical Activity Questionnaire for Adolescents is a self-administered instrument designed to assess the overall level of physical activity of adolescents during the previous seven days, including physical activity performed at school, during leisure time, and on weekends.

    Scale range:

    The total score ranges from 1 to 5 and is calculated as the average score of the questionnaire items.

    Interpretation of scores:

    Higher scores indicate a higher level of physical activity. Lower scores indicate a lower level of physical activity.

  8. Health-related quality of life

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

    Name of the scale: KIDSCREEN-27 Health-Related Quality of Life Questionnaire Scale description:The KIDSCREEN-27 Health-Related Quality of Life Questionnaire is a self-administered instrument designed to assess health-related quality of life in children and adolescents. It evaluates five dimensions: Physical Well-being, Psychological Well-being, Autonomy and Parent Relations, Social Support and Peers, and School Environment.

    Scale range: Each dimension is scored on a 5-point Likert scale, and dimension scores are transformed into standardized values ranging from 0 to 100.

    Interpretation of scores: Higher scores indicate better health-related quality of life. Lower scores indicate poorer health-related quality of life.

    Direction of outcome: Higher scores represent a better outcome.

Other outcomes

  1. Sociodemographic Characteristics (Covariates)

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

    Name of the measure: Family socioeconomic status Description: Family socioeconomic status will be assessed using a questionnaire completed by parents or legal guardians. The questionnaire will collect information on parental educational level, household income, and family structure. These variables will be combined to classify participants into predefined socioeconomic status categories for descriptive and adjustment purposes.

    Unit of measure: Categorical variable (low, medium, high socioeconomic status). Range: Not applicable. Direction of outcome: Not applicable (descriptive covariate)

Study contacts

Contact information is provided by the study sponsor or research team.

Eugenio N Merellano Navarro, Doctor

CONTACT

[email protected]

+56982307921

María P Pezoa Fuentes, Doctor

CONTACT

[email protected]

+56988816597

Sponsors and collaborators

Lead sponsor

Universidad Católica del Maule

Other

Registry information

Official study title

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.

Acronym: Renew

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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