NCT06451367

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

June 28, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

May 27, 2024

Last Update Submit

June 19, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Hormonal changes: Cortisol

    Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).

  • Hormonal changes: Testosterone

    Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).

Study Arms (2)

Intervention

EXPERIMENTAL

Regular football training and neuromuscular training program for 12 weeks

Other: neuromuscular programm

Controle

NO INTERVENTION

Regular football training

Interventions

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

Intervention

Eligibility Criteria

Age14 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endocrine System DiseasesCardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Maristella Santi, Dr. med

CONTACT

Johannes Wildhaber-Brooks, Prof. Dr. med.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 11, 2024

Study Start

June 28, 2024

Primary Completion

October 30, 2024

Study Completion

December 31, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share