Clinical trial NCT06451367: Cardiovascular and Endocrine Response to Muscular Training Program of Young Soccer Players Aged 14-18 Years
Official title: Cardiovascular and Endocrine Response to Muscular Training Program of Young Soccer Players Aged 14-18 Years
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sport Injury
Hormone Disturbance
Cardiovascular Abnormalities
Lead sponsor: Hôpital Fribourgeois
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 30
Sex: MALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either a control group or an intervention group (N=30, with 15 participants in each group). This study focuses on football players aged 14 to 18 who are part of the elite team of the football society of Fribourg, Switzerland.

In the control group, participants engage exclusively in regular football training, whereas participants in the intervention group also participate in a 12-week neuromuscular development program.

Measurements

Before and after the intervention, various measurements are taken for each participant, including:

Blood steroid profile Heart rate variability Lung function using ergospirometry (VO2 max with lactate) Body composition using the Inbody 770 machine Muscular strength using a Newton measurement
Primary purpose: PREVENTION

Brief summary: This study focuses on understanding the cardiovascular and endocrine responses of young soccer players aged 14 to 18 years to a muscular training program. Adolescence is a critical period for physiological development, and investigating these responses can provide insights crucial for athletic performance and overall health. The benefits include promoting overall health, reducing injury risk, and enhancing scientific knowledge. However, intensive training programs may lead to overtraining and potential negative health outcomes if not carefully monitored. The study aims to assess whether additional neuromuscular development over 12 weeks can enhance players' physical fitness and hormonal changes. By examining these outcomes, the study seeks to inform evidence-based training protocols for optimizing adolescent athletes' health and performance in soccer. The study design involves a prospective single-center randomized cohort to investigate these responses comprehensively.

Detailed description: In this study, participants aged 14 to 18, who are part of an elite football team in Fribourg, Switzerland, are randomly assigned to either a control group or an intervention group (N=30, with 15 participants in each group). The control group undergoes regular football training, while the intervention group additionally participates in a 12-week neuromuscular development program. Before and after the intervention, various measurements are taken for each participant, including blood steroid profile, heart rate variability, lung function (VO2 max with lactate), body composition using the Inbody 770 machine, and muscular strength. The control group exclusively engages in regular football training throughout the study duration.

Eligibility criteria: Inclusion Criteria:

* Engaging in a football training program.
* No history of injuries in the last 6 months requiring surgical intervention.
* No intake of anabolic supplements.
* Age 14-18 years old.
* Normal BMI (18.5 - 24.9 kg/m²).

Parents and participants must consent to receive all pertinent information discovered during the study, such as potential cardiovascular diseases or hormonal disorders.

Participants must also consent to the sharing of certain private information with their parents or legal guardians. This includes information regarding cannabis use, as well as the consumption of anabolic steroids and other controlled substances. This additional consent ensures transparency and openness in sharing relevant health-related information with parents or legal guardians, particularly for participants under 18 years of age.

For participants under the age of 18, parental consent or consent from a legal guardian is mandatory in addition to the participant's consent. This ensures that minors have parental approval to take part in the study.

All participants, regardless of age, must provide their voluntary consent to participate in the study. For participants under the age of 18, consent from one of their parents or legal guardians is also required in addition to the participant's consent.

Exclusion Criteria:

* Engaging in other supplemental individual exercise programs.
* Being a smoker (\>1 cigarette/week).
* Using any medication at the time of testing.
* Having any disease.

Primary outcomes:
measure: VO2 max, lactate
timeFrame: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
measure: Heart rate variability
timeFrame: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
measure: Body composition
timeFrame: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
Secondary outcomes:
measure: Hormonal changes: Cortisol
timeFrame: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
measure: Hormonal changes: Testosterone
timeFrame: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
Other outcomes:
Locations:
Study officials:
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