Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06451367
Other study ID # YoungSoccer_14-18
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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).
See also
  Status Clinical Trial Phase
Recruiting NCT05243134 - The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation
Terminated NCT04586179 - A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion N/A
Not yet recruiting NCT04418063 - Glenohumeral Internal Rotation Deficit in Non-pitcher Overhead Athletic Athletes: Case Series Analysis of Athletes
Not yet recruiting NCT05317130 - A Complex Health Promotion Intervention in Parasport - The Safe & Healthy Parasport Project
Completed NCT05861882 - ASSESSMENT OF THE HANDBALL PLAYERS
Completed NCT05254470 - Real-World Experience of Patients Treated for Musculoskeletal Injuries With SAM in Routine Care
Completed NCT05247359 - Neuromuscular Deficits in Jump-Landing Technique in Young Basketball
Completed NCT04780906 - Influence of Wrist Taping on Handgrip Strength in Crossfit Athletes N/A
Completed NCT04641520 - Shoulder Profile Among Swimmers and Badminton Players
Enrolling by invitation NCT03312504 - Implementing a School Prevention Program to Reduce Injuries Through Neuromuscular Training N/A
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Completed NCT04730167 - The Monaco Initiative for Concussion in Motorsport Pilots
Completed NCT03310450 - Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels
Completed NCT04637607 - Immediate Effect of Non-invasive Auricular Acupoint Stimulation for the Performance and the Meridian Activities of Archery Athletes N/A
Completed NCT04284358 - Does Peer to Peer Learning Facilitated by an iPad Application Help Coaches Learn a Neuromuscular Training Warmup? N/A
Completed NCT04589780 - Is There a Relationship Between the Risk of Injury and Posture in Wrestlers?
Completed NCT05827484 - The Effect of Combined Use of Anti-fibrotic Agent With Platelet Rich Plasma on Skeletal Muscle Healing After Acute Injuries Phase 4
Recruiting NCT05326555 - Dynamic Vision Testing and Concussion Management Dream Team 65
Completed NCT04504929 - The Effectiveness of Dynamic Taping in Preventing Muscle Fatigue N/A
Completed NCT04181242 - Epidemiology of Injuries in Elite Badminton Players: a Prospective Study