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

Sport Injury Clinical Trial

— YoungSoccer  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451367
• Other study ID #: YoungSoccer_14-18
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Hôpital Fribourgeois
• Contact: Maristella Santi, Dr. med
• Phone: 079 720 95 20
• Email: maristella.santi[@]h-fr.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this study, participants, aged 14 to 18, who are part of the 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• Engaging in football training program

• Without past 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 who are 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:

• No other supplemental individual exercise programs

• Being a smoker (> 1 cigarette/week),

• Using any medication at the time of testing, and having any disease.

Related Conditions & MeSH terms

• Athletic Injuries
• Cardiovascular Abnormalities
• Endocrine System Diseases
• Hormone Disturbance
• Sport Injury

Intervention

Other:
• neuromuscular programm
neuromuscular programm during 12 weeks (3 times a week, 10 minutes each time)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Fribourgeois

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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	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).
Secondary	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).