NCT07007624

Brief Summary

The current project is a longitudinal, clinical study focused on evaluating the effects of a structured physical activity intervention in healthy prepubertal boys. The study will be conducted with the collaboration of the Pediatrics Department and the Nutrition and Metabolism Area of the Reina Sofía University Hospital in Córdoba; the Child Metabolism and Nutrigenomics. Metabolic Syndrome research groups at the Maimónides Institute for Biomedical Research (IMIBIC); and the Departments of Biochemistry at both the University of Córdoba and the University of Granada. A total of 20 male participants, aged 9 to 12 years, will be selected. Inclusion criteria include being healthy, in Tanner stage I of pubertal development, and having anthropometric and cardiovascular parameters (weight, height, BMI, heart rate, systolic and diastolic blood pressure) within the 50th percentile ±1 standard deviation. Children outside this range, or with signs of pubertal development, will be excluded. The intervention consists of a 3-year physical activity program structured into two annual phases: a 6-week preseason beginning each September, followed by a 32-week season coinciding with the academic year. During the preseason, participants will undergo five weekly 2-hour training sessions. The season will include three 2-hour after-school training sessions per week, and one weekend match. Training sessions will be divided into two parts: individual skill development at moderate to high intensity (60-85% HR) and gameplay focusing on tactics and strategy. All sessions will be supervised by highly qualified coaches. Physical fitness will be assessed through the Eurofit test battery, including the Course Navette, Sit and Reach, 30-second Sit-ups, and Standing Long Jump tests. Physical activity levels will be monitored using accelerometers, and data on weekly activity frequency, intensity, sedentary behavior, and leisure time will be collected. A comprehensive physical examination will include assessment of pubertal development, anthropometry, heart rate, and blood pressure. Body composition will be measured using TANITA BC-418 bioimpedance equipment, and will include height, weight, lean and fat mass, and body water percentage. Additionally, biochemical markers of general health, inflammation (via LINCOplex assays and Luminex xMAP technology), and oxidative stress will be analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
Last Updated

June 6, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

May 5, 2025

Last Update Submit

June 5, 2025

Conditions

Keywords

BasketballInflammationSportsHealthChildhoodDiet

Outcome Measures

Primary Outcomes (8)

  • Body composition: Height

    Height in centimeters is measured with the SECA 213 precision measuring instrument on an annual basis.

    In the first year, measurements were taken at baseline (September), and at 6, 9, and 12 months. In the third year, the same measurement schedule was repeated.

  • Body composition: Weight

    Weight in grams is measured by the precision weighing scale model Tanita 780PMA on an annual basis.

    In the first year, measurements were taken at baseline (September), and at 6, 9, and 12 months. In the third year, the same measurement schedule was repeated.

  • Body composition: Body mass index

    Body mass index in kilograms per square meter is calculated on an annual basis.

    In the first year, measurements were taken at baseline (September), and at 6, 9, and 12 months. In the third year, the same measurement schedule was repeated.

  • Body composition: Waist circumference

    Waist circumference in centimeters is measured with a SECA 201 precision measuring tape on an annual basis.

    In the first year, measurements were taken at baseline (September), and at 6, 9, and 12 months. In the third year, the same measurement schedule was repeated.

  • Muscular strength

    The upper and lower body strength was assayed by the flexed arm hang (FAH) and horizontal jump test, quantifying the time maintaining a flexion and the distance reached in the jumps, respectively

    Measurements were taken at baseline in September and 9 months later in June during the first year. This same schedule was repeated in the third year.

  • Cardiorespiratory endurance

    Cardiorespiratory endurance is assessed in minutes by using the Course Navette test. The number of completed series is recorded.

    Measurements were taken at baseline in September and 9 months later in June during the first year. This same schedule was repeated in the third year.

  • Anaerobic capacity

    Core strength was evaluated by the number of abdominals in 30 seconds

    Measurements were taken at baseline in September and 9 months later in June during the first year. This same schedule was repeated in the third year.

  • Anaerobic capacity

    Anaerobic capacity was assessed by the speed test (40 m)

    Measurements were taken at baseline in September and 9 months later in June during the first year. This same schedule was repeated in the third year.

Secondary Outcomes (67)

  • Assessment of dietary intake and habits

    September, January, April, and June of the first year, September of the second year, and September of the third year.

  • Body composition: Fat mass

    In the first year, measurements were taken at baseline (September), and at 6, 9, and 12 months. In the third year, the same measurement schedule was repeated.

  • Body composition: Fat mass index

    In the first year, measurements were taken at baseline (September), and at 6, 9, and 12 months. In the third year, the same measurement schedule was repeated.

  • Body composition: Fat-free mass

    Measurements were taken at baseline in September and 9 months later in June during the first year. This same schedule was repeated in the third year.

  • Body composition: Total body water

    Measurements were taken at baseline in September and 9 months later in June during the first year. This same schedule was repeated in the third year.

  • +62 more secondary outcomes

Study Arms (1)

Basketball training (Sport and diet)

EXPERIMENTAL
Other: Basketball training (Sport and diet)

Interventions

The intervention program will last for 3 years, and each year will be divided into two periods: a preseason, beginning in early September and lasting for the first 6 weeks, followed immediately by a 32-week season (until the end of the school year). The preseason will include 5 training sessions per week, each lasting 2 hours (Monday to Friday). The following season will include 3 training sessions per week, each lasting 2 hours (after school), and one match on the weekend. Each session will be divided into 2 periods separated by a 10-minute break: the first period will focus on individual skills with moderate to high-intensity exercises (60-85% of heart rate), and the second period will focus on gameplay (tactics and strategy). The trainers had a high level of professional training, ensuring the quality of the sessions. Dietary recommendations based on the Mediterranean diet will be given to the subjects.

Basketball training (Sport and diet)

Eligibility Criteria

Age9 Years - 12 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy male children
  • Weight, height, BMI, heart rate, systolic and diastolic blood pressure within the 50th percentile ±1 SD
  • Tanner stage I of pubertal development

You may not qualify if:

  • Boys younger than 9 or older than 12 years
  • Anthropometric or physiological values above the 75th or below the 25th percentile

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMIBIC

Córdoba, Spain

Location

Related Publications (2)

  • Castro-Collado C, Jurado-Castro JM, Gil-Campos M, Cruz Rico M, Pastor-Villaescusa B, Quintana-Navarro GM, Llorente-Cantarero FJ. Changes in body composition and low-grade inflammation status in boys during a basketball afterschool program for three years. Sci Rep. 2025 Nov 6;15(1):38916. doi: 10.1038/s41598-025-22628-5.

  • Castro-Collado C, Jurado-Castro JM, Gil-Campos M, Pastor-Villaescusa B, Quintana-Navarro GM, Llorente-Cantarero FJ. Effects of After-School Basketball Program on Physical Fitness and Cardiometabolic Health in Prepubertal Boys. Sports (Basel). 2025 Aug 28;13(9):291. doi: 10.3390/sports13090291.

MeSH Terms

Conditions

Inflammation

Interventions

Diet

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2025

First Posted

June 6, 2025

Study Start

October 1, 2021

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

June 6, 2025

Record last verified: 2025-04

Locations