Sport InjuryYoungSoccerNCT06451367
Cardiovascular and Endocrine Response to Muscular Training Program of Young Soccer Players Aged 14-18 Years
A study testing neuromuscular programm in people with Sport Injury and Hormone Disturbance, run by Hôpital Fribourgeois.
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… Read more about this study
- Who is it for?
- Ages 14 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sport Injury, Hormone Disturbance, Cardiovascular Abnormalities
- What is being tested?
- neuromuscular programm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Engaging in other supplemental individual exercise programs.
- Being a smoker (>1 cigarette/week).
- Using any medication at the time of testing.
- Having any disease.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- neuromuscular programm
- Medical subject headings
- Endocrine System Diseases, Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular programmOther
neuromuscular programm during 12 weeks (3 times a week, 10 minutes each time)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Regular football training and neuromuscular training program for 12 weeks Receives: Other: neuromuscular programm |
| Controle | No intervention | Regular football training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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
Measured: 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
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.
Measured: 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.
Measured: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start28 Jun 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Fribourgeois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451367
- Sponsor's protocol ID
- YoungSoccer_14-18
- Acronym
- YoungSoccer
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Endocrine Response to Muscular Training Program of Young Soccer Players Aged 14-18 Years
- ClinicalTrials.gov ID
- NCT06451367
- Acronym / sponsor ID
- YoungSoccer / YoungSoccer_14-18
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hôpital FribourgeoisUniversity, hospital or other
- Study start
- 28 Jun 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: neuromuscular programmRegular football training and neuromuscular training program for 12 weeks |
| Controle | No intervention | –Regular football training |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (4 listed)
- Engaging in other supplemental individual exercise programs.
- Being a smoker (>1 cigarette/week).
- Using any medication at the time of testing.
- Having any disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscular programmneuromuscular programm during 12 weeks (3 times a week, 10 minutes each time) | Other | Intervention |
Primary outcome
VO2 max, lactate
Time frame: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
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)
Heart rate variability
Time frame: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
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).
Body composition
Time frame: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
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
2 secondary outcomes
Hormonal changes: Cortisol
Time frame: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
Hormonal changes: Testosterone
Time frame: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular programm in people with Sport Injury and Hormone Disturbance, run by Hôpital Fribourgeois.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maristella Santi, Dr. med (079 720 95 20, maristella.santi@h-fr.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max, lactate (time frame: Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.