Clinical trial NCT07007624: Basketball Intervention Program in Children
Official title: Basketball Intervention Program In Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basketball
Keywords: Basketball
Inflammation
Sports
Health
Childhood
Diet
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 17
Sex: MALE
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Body composition: Height
timeFrame: 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.
measure: Body composition: Weight
timeFrame: 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.
measure: Body composition: Body mass index
timeFrame: 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.
measure: Body composition: Waist circumference
timeFrame: 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.
measure: Muscular strength
timeFrame: 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.
measure: Cardiorespiratory endurance
timeFrame: 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.
measure: Anaerobic capacity
timeFrame: 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.
measure: Anaerobic capacity
timeFrame: 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:
measure: Assessment of dietary intake and habits
timeFrame: September, January, April, and June of the first year, September of the second year, and September of the third year.
measure: Body composition: Fat mass
timeFrame: 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.
measure: Body composition: Fat mass index
timeFrame: 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.
measure: Body composition: Fat-free mass
timeFrame: 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.
measure: Body composition: Total body water
timeFrame: 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.
measure: Systolic blood pressure measurement
timeFrame: 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.
measure: Diastolic blood pressure measurement
timeFrame: 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.
measure: Heart rate measurement
timeFrame: 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.
measure: Hematological analysis: Hemoglobine
timeFrame: 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.
measure: Hematological analysis: Hematocrite
timeFrame: 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.
measure: Hematological analysis: Erythrocytes
timeFrame: 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.
measure: Hematological analysis: Mean corpuscular volume
timeFrame: 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.
measure: Hematological analysis: Mean corpuscular hemoglobin
timeFrame: 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.
measure: Hematological analysis: Mean corpuscular hemoglobin concentration
timeFrame: 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.
measure: Hematological analysis: Red cell blood distribution width
timeFrame: 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.
measure: Hematological analysis: White blood cells
timeFrame: 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.ual basis.
measure: Hematological analysis: Neutrophils
timeFrame: 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.
measure: Hematological analysis: Lymphocytes
timeFrame: 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.
measure: Hematological analysis: Monocytes
timeFrame: 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.
measure: Hematological analysis: Eosinophils
timeFrame: 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.
measure: Hematological analysis: Basophiles
timeFrame: 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.
measure: Hematological analysis: Platelets
timeFrame: 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.
measure: Hematological analysis: Mean platelet volume
timeFrame: 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.
measure: Biochemical analysis: Glucose
timeFrame: 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.
measure: Biochemical analysis: Bilirubin
timeFrame: 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.
measure: Biochemical analysis: Creatinine
timeFrame: 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.
measure: Biochemical analysis: Urate
timeFrame: 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.
measure: Biochemical analysis: Urea
timeFrame: 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.
measure: Biochemical analysis: Total protein
timeFrame: 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.
measure: Biochemical analysis: Aspartate aminotransferase
timeFrame: 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.
measure: Biochemical analysis: Alanine aminotransferase
timeFrame: 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.
measure: Biochemical analysis: Gamma-glutamyl transferase
timeFrame: 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.
measure: Biochemical analysis: Alkaline phosphatase
timeFrame: 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.
measure: Biochemical analysis: Total cholesterol
timeFrame: 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.
measure: Biochemical analysis: High density lipoproteins
timeFrame: 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.
measure: Biochemical analysis: Non-HDL cholesterol
timeFrame: 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.
measure: Biochemical analysis: Low density lipoproteins
timeFrame: 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.
measure: Biochemical analysis: Apolipoprotein A1
timeFrame: 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.
measure: Biochemical analysis: Apolipoprotein B
timeFrame: 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.
measure: Biochemical analysis: Calcium
timeFrame: 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.
measure: Biochemical analysis: Potassium
timeFrame: 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.
measure: Biochemical analysis: Sodium
timeFrame: 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.
measure: Biochemical analysis: Phosphorus
timeFrame: 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.
measure: Biochemical analysis: Iron
timeFrame: 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.
measure: Biochemical analysis: Magnesium
timeFrame: 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.
measure: Biochemical analysis: Zinc
timeFrame: 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.
measure: Biochemical analysis: Insulin
timeFrame: 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.
measure: Biochemical analysis: Insulin resistance
timeFrame: 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.
measure: Biochemical analysis: C-reactive protein
timeFrame: 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.
measure: Biochemical analysis: Tumor necrosis factor alpha
timeFrame: 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.
measure: Biochemical analysis: Adiponectin
timeFrame: 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.
measure: Biochemical analysis: IL-6
timeFrame: 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.
measure: IL-8
timeFrame: 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.
measure: Biochemical analysis: NGF
timeFrame: 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.
measure: Biochemical analysis: TNFa
timeFrame: 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.
measure: Biochemical analysis: MCP-1
timeFrame: 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.
measure: Biochemical analysis: Total PAI-1
timeFrame: 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.
measure: Biochemical analysis: HGF
timeFrame: 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.
measure: Biochemical analysis: Energy
timeFrame: September, January, April, and June of the first year, September of the second year, and September of the third year.
measure: Biochemical analysis: Carbohydrates
timeFrame: September, January, April, and June of the first year, September of the second year, and September of the third year.
measure: Biochemical analysis: Sugars
timeFrame: September, January, April, and June of the first year, September of the second year, and September of the third year.
measure: Biochemical analysis: Fiber
timeFrame: September, January, April, and June of the first year, September of the second year, and September of the third year.
measure: Biochemical analysis: Polysaccharides
timeFrame: September, January, April, and June of the first year, September of the second year, and September of the third year.
measure: Biochemical analysis: Total fat
timeFrame: September, January, April, and June of the first year, September of the second year, and September of the third year.
measure: Biochemical analysis: Saturated fatty acids
timeFrame: September, January, April, and June of the first year, September of the second year, and September of the third year.
measure: Biochemical analysis: Monounsaturated fatty acids
timeFrame: September, January, April, and June of the first year, September of the second year, and September of the third year.
measure: Biochemical analysis: Polyunsaturated fatty acids
timeFrame: September, January, April, and June of the first year, September of the second year, and September of the third year.
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: IMIBIC
Study officials:
References: