BasketballBIPICNCT07007624
Basketball Intervention Program in Children
A study testing Basketball training (Sport and diet) in people with Basketball, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Basketball
- What is being tested?
- Basketball training (Sport and diet)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Boys younger than 9 or older than 12 years
- Anthropometric or physiological values above the 75th or below the 25th percentile
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Basketball Intervention Program In Children
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.
Read more
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.
- Conditions
- Basketball
- Being tested
- Basketball training (Sport and diet)
- Keywords
- Basketball, Inflammation, Sports, Health, Childhood, Diet
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basketball training (Sport and diet)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Basketball training (Sport and diet) | Experimental | Not described Receives: Other: Basketball training (Sport and diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition: Height
Height in centimeters is measured with the SECA 213 precision measuring instrument on an annual basis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
The habitual intake of the child is assessed by using the food and drink frequency questionnaire and KID-MED.
The KIDMED index ranges from -4 to 12 points. Higher scores indicate greater adherence to the Mediterranean diet and therefore a better dietary quality. A total score is calculated based on 16 yes/no questions: positive connotations are scored +1, and negative connotations are scored -1.
Measured: September, January, April, and June of the first year, September of the second year, and September of the third year.
Body composition: Fat mass
Fat mass both in kilograms and in percentage is measured on an annual basis.
Measured: 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
Fat mass index in kilograms per square meter is calculated on an annual basis.
Measured: 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
Fat-free mass in kilograms is measured on an annual basis.
Measured: 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
Total body water both in kilograms and in percentage is measured on an annual basis.
Measured: 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.
Systolic blood pressure measurement
On an annual basis, the systolic blood pressure is measured in mmHg in triplicate in order to obtain an average value.
Measured: 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.
Diastolic blood pressure measurement
On an annual basis, the diastolic blood pressure is measured in mmHg in triplicate in order to obtain an average value.
Measured: 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.
Heart rate measurement
On an annual basis, the heart rate is measured in beats per minute in triplicate in order to obtain an average value.
Measured: 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.
Hematological analysis: Hemoglobine
Hemoglobin levels are determined in grams per deciliter on an individual basis.
Measured: 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.
Hematological analysis: Hematocrite
Hematocrite levels are determined in percentage on an individual basis.
Measured: 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.
Hematological analysis: Erythrocytes
Erythrocytes count is measured in 10e06 units per microliter on an individual basis.
Measured: 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.
Hematological analysis: Mean corpuscular volume
Mean corpuscular volume is measured in femtoliters on an individual basis.
Measured: 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.
Hematological analysis: Mean corpuscular hemoglobin
Mean corpuscular hemoglobine is measured in picograms on an individual basis.
Measured: 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.
Hematological analysis: Mean corpuscular hemoglobin concentration
Mean corpuscular hemoglobine concentration is measured in grams per deciliter on an individual basis.
Measured: 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.
Hematological analysis: Red cell blood distribution width
Red cell blood distribution width is determined in percentage on an individual basis.
Measured: 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.
Hematological analysis: White blood cells
White blood cells count is measured in 10e03 units per microliter on an individual basis.
Measured: 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.
Hematological analysis: Neutrophils
Neutrophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Measured: 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.
Hematological analysis: Lymphocytes
Lymphocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Measured: 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.
Hematological analysis: Monocytes
Monocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Measured: 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.
Hematological analysis: Eosinophils
Eosinophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Measured: 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.
Hematological analysis: Basophiles
Basophiles count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Measured: 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.
Hematological analysis: Platelets
Platelets count is measured in 10e03 units per microliter on an individual basis.
Measured: 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.
Hematological analysis: Mean platelet volume
Mean platelet volume is measured in femtoliters on an individual basis.
Measured: 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.
Biochemical analysis: Glucose
Glucose is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Bilirubin
Total bilirubin is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Creatinine
Creatinine is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Urate
Urate is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Urea
Urea is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Total protein
Total protein is measured both in grams per deciliter and in grams on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Aspartate aminotransferase
Aspartate aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Alanine aminotransferase
Alanine aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Gamma-glutamyl transferase
Gamma-glutamyl transferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Alkaline phosphatase
Alkaline phosphatase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Total cholesterol
Total cholesterol is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: High density lipoproteins
High density lipoproteins (HDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Non-HDL cholesterol
Non-HDL cholesterol levels are calculated in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Low density lipoproteins
Low density lipoproteins (LDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Apolipoprotein A1
Apolipoprotein A1 is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Apolipoprotein B
Apolipoprotein B is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Calcium
Calcium is measured both in milligrams per deciliter and in milligrams on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Potassium
Potassium is measured both in millimoles per liter and in milligrams on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Sodium
Sodium is measured in millimoles per liter, in milliequivalents per liter and in milligrams on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Phosphorus
Phosphorus is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Iron
Iron is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Magnesium
Magnesium is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Zinc
Zinc is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Insulin
Insulin is measured both in micro international units per liter and in picograms per milliliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Insulin resistance
The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index is used to estimate insulin resistance.
Measured: 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.
Biochemical analysis: C-reactive protein
C-reactive protein is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Tumor necrosis factor alpha
Tumor necrosis factor alpha is measured in picograms per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Adiponectin
Adiponectin is measured in milligrams per liter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: IL-6
Il-6 is measured in picograms per milliliter on an individual basis. Analysis performed in plasma.
Measured: 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.
IL-8
IL-8 is measured in picograms per milliliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: NGF
NGF is measured in picograms per milliliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: TNFa
TNFa is measured in picograms per milliliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: MCP-1
MCP-1 is measured in picograms per milliliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Total PAI-1
Total PAI-1is measured in units per milliliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: HGF
HGF is measured in nanograms per milliliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Biochemical analysis: Energy
Energy is determined in kilocalories on an individual basis. Analysis performed in plasma.
Measured: September, January, April, and June of the first year, September of the second year, and September of the third year.
Biochemical analysis: Carbohydrates
Carbohydrates are measured in grams on an individual basis. Analysis performed in plasma.
Measured: September, January, April, and June of the first year, September of the second year, and September of the third year.
Biochemical analysis: Sugars
Sugars are measured in grams on an individual basis. Analysis performed in plasma.
Measured: September, January, April, and June of the first year, September of the second year, and September of the third year.
Biochemical analysis: Fiber
Fibers are measured in grams on an individual basis. Analysis performed in plasma.
Measured: September, January, April, and June of the first year, September of the second year, and September of the third year.
Biochemical analysis: Polysaccharides
Polysaccharides are measured in grams on an individual basis. Analysis performed in plasma.
Measured: September, January, April, and June of the first year, September of the second year, and September of the third year.
Biochemical analysis: Total fat
Total fat is measured in grams on an individual basis. Analysis performed in plasma.
Measured: September, January, April, and June of the first year, September of the second year, and September of the third year.
Biochemical analysis: Saturated fatty acids
Saturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Measured: September, January, April, and June of the first year, September of the second year, and September of the third year.
Biochemical analysis: Monounsaturated fatty acids
Monounsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Measured: September, January, April, and June of the first year, September of the second year, and September of the third year.
Biochemical analysis: Polyunsaturated fatty acids
Polyunsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Measured: September, January, April, and June of the first year, September of the second year, and September of the third year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Oct 2021
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BasketballStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007624
- Sponsor's protocol ID
- BIPIC
- Acronym
- BIPIC
- Status last verified
- Apr 2025
- First submitted
- 5 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41198734Castro-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.
PubMed 41003597
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basketball Intervention Program In Children
- ClinicalTrials.gov ID
- NCT07007624
- Acronym / sponsor ID
- BIPIC / BIPIC
- Conditions
- Basketball
- Keywords
- Basketball, Inflammation, Sports, Health, Childhood, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basketball training (Sport and diet) | Experimental | Other: Basketball training (Sport and diet) |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Boys younger than 9 or older than 12 years
- Anthropometric or physiological values above the 75th or below the 25th percentile
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basketball training (Sport and diet)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. | Other | Basketball training (Sport and diet) |
Primary outcome
Body composition: Height
Time frame: 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.
Height in centimeters is measured with the SECA 213 precision measuring instrument on an annual basis.
Body composition: Weight
Time frame: 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.
Weight in grams is measured by the precision weighing scale model Tanita 780PMA on an annual basis.
Body composition: Body mass index
Time frame: 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 mass index in kilograms per square meter is calculated on an annual basis.
Body composition: Waist circumference
Time frame: 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.
Waist circumference in centimeters is measured with a SECA 201 precision measuring tape on an annual basis.
Muscular strength
Time frame: 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.
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
Cardiorespiratory endurance
Time frame: 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 is assessed in minutes by using the Course Navette test. The number of completed series is recorded.
Anaerobic capacity
Time frame: 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.
Core strength was evaluated by the number of abdominals in 30 seconds
Anaerobic capacity
Time frame: 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 was assessed by the speed test (40 m)
67 secondary outcomes
Assessment of dietary intake and habits
Time frame: September, January, April, and June of the first year, September of the second year, and September of the third year.
Body composition: Fat mass
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Systolic blood pressure measurement
Time frame: 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.
Diastolic blood pressure measurement
Time frame: 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.
Heart rate measurement
Time frame: 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.
Hematological analysis: Hemoglobine
Time frame: 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.
Hematological analysis: Hematocrite
Time frame: 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.
Hematological analysis: Erythrocytes
Time frame: 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.
Hematological analysis: Mean corpuscular volume
Time frame: 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.
Hematological analysis: Mean corpuscular hemoglobin
Time frame: 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.
Hematological analysis: Mean corpuscular hemoglobin concentration
Time frame: 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.
Hematological analysis: Red cell blood distribution width
Time frame: 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.
Hematological analysis: White blood cells
Time frame: 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.
Hematological analysis: Neutrophils
Time frame: 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.
Hematological analysis: Lymphocytes
Time frame: 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.
Hematological analysis: Monocytes
Time frame: 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.
Hematological analysis: Eosinophils
Time frame: 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.
Hematological analysis: Basophiles
Time frame: 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.
Hematological analysis: Platelets
Time frame: 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.
Hematological analysis: Mean platelet volume
Time frame: 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.
Biochemical analysis: Glucose
Time frame: 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.
Biochemical analysis: Bilirubin
Time frame: 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.
Biochemical analysis: Creatinine
Time frame: 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.
Biochemical analysis: Urate
Time frame: 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.
Biochemical analysis: Urea
Time frame: 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.
Biochemical analysis: Total protein
Time frame: 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.
Biochemical analysis: Aspartate aminotransferase
Time frame: 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.
Biochemical analysis: Alanine aminotransferase
Time frame: 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.
Biochemical analysis: Gamma-glutamyl transferase
Time frame: 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.
Biochemical analysis: Alkaline phosphatase
Time frame: 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.
Biochemical analysis: Total cholesterol
Time frame: 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.
Biochemical analysis: High density lipoproteins
Time frame: 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.
Biochemical analysis: Non-HDL cholesterol
Time frame: 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.
Biochemical analysis: Low density lipoproteins
Time frame: 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.
Biochemical analysis: Apolipoprotein A1
Time frame: 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.
Biochemical analysis: Apolipoprotein B
Time frame: 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.
Biochemical analysis: Calcium
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Derived from this study: PubMed 41198734Castro-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.
- Derived from this study: PubMed 41003597Castro-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basketball training (Sport and diet) in people with Basketball, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition: Height (time frame: 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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07007624, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.