- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07170930
- Original Trial
The Effect of a Training Programme in the Variation of Fitness Parameters, Physiological, Hematological and Biochemical Indicators of Soccer Players During the Preseason Period
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Daphni
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Athens, Daphni, Greece, 17237
- School of Physical Education and Sports Science, National and Kapodistrian University of Athens
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male participants
- Aged 18 years or older
- Non-smokers
- Injury-free for the past 6 months
- Medication-free for the past 6 months
- Abstinent from alcohol
- Living at an altitude below 1500 meters
- Committed exclusively to soccer (no participation in other sports)
Exclusion Criteria:
- History of serious injuries (e.g., fractures, ligament tears) within the past 6 months
- Chronic medical conditions such as cardiovascular disease, diabetes, or respiratory disorders
- Current use of performance-enhancing drugs or supplements
- Participation in non-soccer-related sports or activities during the study period
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Extended-Play
Participants with higher cumulative friendly match-play exposure during the late pre-season phase.
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This research explores the multidimensional physiological and biochemical responses to differing volumes of friendly match-play (i.e., extended vs. limited) during the late pre-season phase in soccer players.
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Limited-Play
Participants with lower cumulative friendly match-play exposure during the late pre-season phase.
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This research explores the multidimensional physiological and biochemical responses to differing volumes of friendly match-play (i.e., extended vs. limited) during the late pre-season phase in soccer players.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Body mass measured at standard anatomical sites using a calibrated scale to track longitudinal changes over the pre-season. Unit of Measure: kg |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
|
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Body Fat
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Body fat percentage measured using skinfold calipers at standard sites to monitor longitudinal changes. Unit of Measure: % |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
|
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Rate of Perceived Exertion (RPE)
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Participants rate exertion during standardized training sessions using the Borg Scale (6 = no exertion, 20 = maximal exertion). Unit of Measure: Borg 6-20 scale |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Glucose
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Fasting blood glucose measured to track metabolic changes over pre-season. Unit of Measure: mg/dL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
|
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Cholesterol
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Total serum cholesterol measured to assess lipid profile adaptations. Unit of Measure: mg/dL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Triglycerides
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Serum triglycerides measured to monitor metabolic response to training. Unit of Measure: mg/dL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
|
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SGOT (AST)
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Serum glutamic-oxaloacetic transaminase measured to assess liver/muscle stress. Unit of Measure: U/L |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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SGPT (ALT)
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Serum glutamic-pyruvic transaminase measured to monitor liver/muscle stress. Unit of Measure: U/L |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
|
|
Creatine Phosphokinase (CPK)
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: CPK measured to detect skeletal muscle damage. Unit of Measure: U/L |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Myoglobin
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Myoglobin measured as a marker of muscle damage. Unit of Measure: ng/mL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Iron
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Serum iron measured to assess iron status. Unit of Measure: µg/dL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Ferritin
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Serum ferritin measured to monitor iron storage. Unit of Measure: ng/mL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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C-Reactive Protein (CRP)
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: CRP measured as a marker of systemic inflammation. Unit of Measure: mg/L |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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High-sensitivity CRP (hs-CRP)
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: hs-CRP measured to detect low-grade inflammation. Unit of Measure: mg/L |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Interleukin-6 (IL-6)
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: IL-6 measured from serum to assess inflammatory response. Unit of Measure: pg/mL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Tumor Necrosis Factor-alpha (TNF-α)
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: TNF-α measured as a marker of systemic inflammation. Unit of Measure: pg/mL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Testosterone
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Serum testosterone measured to assess hormonal adaptations. Unit of Measure: ng/dL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Cortisol
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Serum cortisol measured to monitor stress response. Unit of Measure: µg/dL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Testosterone-Cortisol Ratio
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Calculated ratio to estimate anabolic-catabolic balance. Unit of Measure: Ratio |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Red Blood Cells (RBC)
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: RBC count measured from blood to assess oxygen transport capacity. Unit of Measure: million cells/µL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Hemoglobin
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Hemoglobin measured to evaluate oxygen-carrying capacity. Unit of Measure: g/dL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Hematocrit
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Hematocrit measured as percentage of RBC in blood. Unit of Measure: % |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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White Blood Cells (WBC)
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: WBC count measured to monitor immune function. Unit of Measure: cells/µL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Platelets
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Platelet count measured to assess hematological health. Unit of Measure: cells/µL |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Countermovement Jump Height
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Jump height measured (cm) to assess lower-limb explosive power. Unit of Measure: cm |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Knee Extensor Power, Dominant Leg
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Measured using isokinetic dynamometer. Unit of Measure: Watts |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Knee Extensor Power, Non-Dominant Leg
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Measured using isokinetic dynamometer. Unit of Measure: Watts |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Knee Flexor Power, Dominant Leg
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Measured using isokinetic dynamometer. Unit of Measure: Watts |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Knee Flexor Power, Non-Dominant Leg
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
|
Description: Measured using isokinetic dynamometer. Unit of Measure: Watts |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
|
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10-m Sprint Time
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Sprint time measured using photocell gates; lower times indicate better performance. Unit of Measure: seconds |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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T-Test Agility
Time Frame: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
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Description: Participants perform T-test agility course; lower times indicate better agility. Unit of Measure: seconds |
Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERC-002/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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