Cardiovascular and Endocrine Response to Muscular Training Program of Young Soccer Players Aged 14-18 Years (YoungSoccer)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Abnormalities; Sport Injury; Hormone Disturbance
• Intervention / Treatment: Other: neuromuscular programm

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maristella Santi, Dr. med; Phone Number: 079 720 95 20; Email: maristella.santi@h-fr.ch
• Study Contact Backup: Name: Johannes Wildhaber-Brooks, Prof. Dr. med.; Phone Number: 026 306 00 00; Email: maristella.santi@h-fr.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controle; Regular football training
Experimental: Intervention; Regular football training and neuromuscular training program for 12 weeks	Other: neuromuscular programm; neuromuscular programm during 12 weeks (3 times a week, 10 minutes each time)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 max, lactate	The study aims to examine the effects of a 12-week supplemental muscle program on cardiopulmonary exercise testing, focusing on key metrics such as maximum oxygen uptake (VO2max in mL/kg/min with capillary lactate measurement in mmol/L)	Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
Heart rate variability	The study aims to examine the effects of a 12-week supplemental muscle program on cardiopulmonary exercise testing, focusing on key metrics such as heart rate variability (HRV in ms).	Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
Body composition	The study aims to examine the effects of a 12-week supplemental muscle program on cardiopulmonary exercise testing, focusing on key metrics such as body composition (percentage of body fat, muscle mass in kg). Height will be measured in centimeters (cm) and weight in kilograms (kg) to calculate the Body Mass Index (BMI) in kg/m²	Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hormonal changes: Cortisol	The study includes a secondary endpoint involving the measurement of cortisol levels (in μg/dL) before and after the muscular training program. These measurements offer valuable insights into the endocrine adaptations induced by the training regimen. By analyzing changes in cortisol levels, researchers can gain a deeper understanding of the hormonal milieu associated with muscle development, recovery, and overall physiological balance.	Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
Hormonal changes: Testosterone	The study includes a secondary endpoint involving the measurement of testosterone levels (in ng/dL) before and after the muscular training program. These measurements offer valuable insights into the endocrine adaptations induced by the training regimen. By analyzing changes in testosterone levels, researchers can gain a deeper understanding of the hormonal milieu associated with muscle development, recovery, and overall physiological balance.	Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).

Collaborators and Investigators

• Sponsor: Hôpital Fribourgeois

Study record dates

Study Major Dates

• Study Start (Estimated): June 28, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Congenital Abnormalities; Endocrine System Diseases; Cardiovascular Abnormalities; Athletic Injuries
• Other Study ID Numbers: YoungSoccer_14-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No