<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03833973</url>
  </required_header>
  <id_info>
    <org_study_id>SuPpOrt-UTH</org_study_id>
    <nct_id>NCT03833973</nct_id>
  </id_info>
  <brief_title>Safety and Prevention of OveRTraining</brief_title>
  <acronym>SuPpOrt</acronym>
  <official_title>The Evaluation of Cell-Free Plasma DNA (cfDNA) and Oxidative Stress Indices as Biomarkers for the Diagnosis and Prevention of Overtraining</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Thessaly</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Athletic training aims to increase and improve physical performance that is achieved through&#xD;
      training overload combined with periods of rest and recovery. Overtraining syndrome (OTS) is&#xD;
      associated with an imbalance between training and recovery. The symptoms associated with OTS&#xD;
      vary between individuals and may reflect parasympathetic and/or sympathetic nervous system&#xD;
      alterations as well as endocrine irregularities. The prevalence is not known, but it is&#xD;
      usually reported among endurance athletes, such as cyclists, distance runners and&#xD;
      triathletes. It appears that OTS represents a systemic inflammatory process with diffuse&#xD;
      effects on the neurohormonal axis affecting host immunology and mood. Previous works, showed&#xD;
      that cell-free DNA (cf-DNA) is correlated with the severity of excessive exercise-induced&#xD;
      inflammation as well as with trauma and stroke severity suggesting that it might be used as a&#xD;
      potential clinical marker for athletes with overtraining syndrome. Oxidative stress indices&#xD;
      can be determined non-invasively and may reflect inflammatory responses after training&#xD;
      suggesting that they could be used as clinical markers for the diagnosis of OTS. However,&#xD;
      there are no available biomarkers to aid towards the diagnosis and/or prevention of OTS,&#xD;
      except that of the persistence of unexplained underperformance despite an extensive recovery&#xD;
      of the athlete. Therefore, the purpose of this study is to evaluate the potential of cf-DNA&#xD;
      and selected oxidative stress variables as diagnostic biomarkers of OTS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total number of 15 elite-level runners (both male and female) and 80-100 soccer players&#xD;
      (both male and female) will participate in the study.The day when participants (runners) will&#xD;
      arrive at the lab early in the morning, after an overnight fast. They will have their blood&#xD;
      pressure and orthostatic heart rate measured and they will also provide a blood sample.&#xD;
      Immediately after participants' body composition will be assessed by dual energy X-ray&#xD;
      absorptiometry (DXA). Then, they will perform the Meeusen test providing a second blood&#xD;
      sample immediately after the test. During the subsequent 4-hour resting period, the&#xD;
      participants followed by assessment of joint mobility, delayed onset of muscle soreness,&#xD;
      flexibility and vertical jump performance after that lower limb peak torque by isokinetic&#xD;
      dynamometer. A second Meeusen test will take place after the resting period with blood&#xD;
      sampling post-testing. Then, participants will have a 3-hour rest, after which they will&#xD;
      visit the lab again in order to perform the running economy testing protocol and a maximal&#xD;
      lactate steady state test. Finally, participants will complete POMS-, quality of sleep- and&#xD;
      symptomatology-related questionnaires and will be taught on how to complete dietary recalls.&#xD;
      Over the subsequent 12-month period participants will provide the investigator with a&#xD;
      detailed report of their training plan and a symptomatology questionnaire every month. These&#xD;
      measurements take place for all participants in two different periods, in transitional&#xD;
      period/baseline and in middle season (berore tha main race). If someone of participants&#xD;
      manifest the symptoms of overtraining, they perform the protocol of measurements again. The&#xD;
      day when participants (soccer players) will arrive at the lab early in the morning, after an&#xD;
      overnight fast. They will have their blood pressure and orthostatic heart rate measured and&#xD;
      they will also provide a blood sample. Immediately after participants' body composition will&#xD;
      be assessed by dual energy X-ray absorptiometry (DXA). The participants followed by&#xD;
      assessment of joint mobility, delayed onset of muscle soreness, flexibility and vertical jump&#xD;
      performance after that lower limb peak torque by isokinetic dynamometer. After resting, they&#xD;
      will measurement the maximum oxygen uptake in stress test on the aisle. The next days, in&#xD;
      football players take place in field tests, will measure the Speed in 10, 30 meters, Yo-Yo&#xD;
      IE2 (Intermittent Endurance 2), Yo-Yo IR2 (Intermittent Recovery 2) and Repeated Sprint&#xD;
      Ability (RSA). Finally, participants (soccer players) will complete POMS-, quality of sleep-&#xD;
      and symptomatology-related questionnaires and will be taught on how to complete dietary&#xD;
      recalls.These measurements take place for all participants in two different periods, in&#xD;
      transitional period/baseline and in middle season (berore tha main race). If someone of&#xD;
      participants manifest the symptoms of overtraining, they perform the protocol again.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cell free plasma DNA</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Cell free plasma DNA will be measured with real-time PCR in plasma samples.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cortisol level</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Cortisol concentration will measured in serum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Testosterone level</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Testosterone concentration will be measured in serum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cytokine response</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Concentration of TNF-α, IL-6 and IL-10 will be measured in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in creatine kinase in plasma</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Concentration of creatine kinase will be measured in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in uric acid in plasma</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Concentration of uric acid will be measured in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in protein carbonyls in blood</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Concentration of protein carbonyls will be measured in red blood cells</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in total antioxidant capacity</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Total antioxidant capacity will be measured in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in reduced glutathione in blood</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Concentration of reduced glutathione will be measured in in red blood cells</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in oxidized glutathione in blood</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Concentration of oxidized glutathione will be measured in red blood cells</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in catalase activity</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Catalase activity will be measured in red blood cells</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in malondialdehyde in blood</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Concentration of malondialdehyde will be measured in serum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in blood lactate concentration</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Blood lactate concentration will be measured during a maximal lactate steady-state test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in peak torque</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Peak torque will be assessed on an isokinetic dynamometer at 60 degrees/sec</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in orthostatic heart rate.</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Heart rate will be measured in a resting position and following 15 seconds of standing by heart rate monitor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in jumping ability.</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Jumping ability will be assessed by measuring squat jump.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in flexibility</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Flexibility will be assessed through the sit and reach test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body composition.</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Body composition will be assessed by dual energy X-ray absorptiometry (DXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in delay onset of muscle soreness (DOMS)</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>DOMS will be assessed by muscle palpation while participants are laying , standing and after performing 3 squats.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in complete blood count</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Complete blood count analysis will be performed on an automatic blood analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in RSA</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>5 x 30 m sprints will be performed with 25 seconds rest in-between. Mean time for 5 sprints and fatigue index will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Yo-Yo IE2</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Yo-Yo IE2 will be assessed using a standardized testing protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Yo-Yo IR2</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Yo-Yo IR2 will be assessed using a standardized testing protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Spreed</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Spreed will be assessed using a standardized testing protocol in 10 and 30 meters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Dietary intake will be assessed using 7-day diet recalls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in jumping ability.</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Jumping ability will be assessed by measuring counter-movement jump.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in jumping ability.</measure>
    <time_frame>At baseline, at six months and at twelve months</time_frame>
    <description>Jumping ability will be assessed by measuring drop jump.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Overtraining Syndrome</condition>
  <arm_group>
    <arm_group_label>Runners</arm_group_label>
    <description>Long-distance runners, marathon runners, 5 km and 10 km runners, both female and male aged 20 - 40 years, participating in regular training and competitions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Soccer Players</arm_group_label>
    <description>High Level soccer players, both female and male aged 15-30, participating in all games</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Overtraining Monitoring</intervention_name>
    <description>Athletes will be thoroughly monitored (i.e. training workload, match activities or event/race performance, markers of inflammation and oxidative stress as well as cell-free DNA) throughout the season in order to establish novel biomarkers that could function as either predictors or diagnostic tools of overtraining.</description>
    <arm_group_label>Runners</arm_group_label>
    <arm_group_label>Soccer Players</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants for the first group will be male and female long-distance, marathon, 5 km and&#xD;
        10 km runners aged 20-40 years. All of them will be active, elite-level runners ,&#xD;
        participating in regular competitive training. For the second group will be male and female&#xD;
        high level soccer players aged 15-30 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Runners:&#xD;
&#xD;
        Participants:&#xD;
&#xD;
          -  should be long-distance runners, marathon runners, 5 km and 10 km runners.&#xD;
&#xD;
          -  should be able to provide the daily training plan and a 7-day dietary recall every&#xD;
             month.&#xD;
&#xD;
          -  should be considered elite level runners.&#xD;
&#xD;
          -  should be free of musculoskeletal injuries for at least one year before the study.&#xD;
&#xD;
        Inclusion Criteria for Soccer Players:&#xD;
&#xD;
        Participants:&#xD;
&#xD;
          -  should be elite soccer players.&#xD;
&#xD;
          -  should be able to provide the daily training plan and a 7-day dietary recall.&#xD;
&#xD;
          -  should be participated in matches.&#xD;
&#xD;
          -  should be free of musculoskeletal injuries for at least one year before the study.&#xD;
&#xD;
        Exclusion Criteria (both Runners and Soccer Players):&#xD;
&#xD;
        If participants:&#xD;
&#xD;
          -  do not adhere to rules of the study.&#xD;
&#xD;
          -  have a recent history of illness or injury .&#xD;
&#xD;
          -  do not participate in competitive training.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vasiliki C Laschou, PhDc</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION &amp; SPORTS SCIENCES</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>IOANNIS G FATOUROS, PhD</last_name>
    <phone>+30 24310 47047</phone>
    <email>ifatouros@pe.uth.gr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>ATHANASIOS Z JAMURTAS, Prof</last_name>
    <phone>+30 24310 47054</phone>
    <email>ajamurt@pe.uth.gr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Exercise Biochemistry Laboratory, School of Physical Education &amp; Sports Sciences, University of Thessaly</name>
      <address>
        <city>Tríkala</city>
        <zip>42100</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ATHANASIOS Z JAMURTAS, Prof</last_name>
      <phone>+302431047054</phone>
      <email>ajamurt@pe.uth.gr</email>
    </contact>
    <contact_backup>
      <last_name>IOANNIS KOUTEDAKIS, Prof</last_name>
      <phone>+302431047056</phone>
      <email>y.koutedakis@uth.gr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>June 5, 2018</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>December 26, 2019</last_update_submitted>
  <last_update_submitted_qc>December 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Thessaly</investigator_affiliation>
    <investigator_full_name>Ioannis G. Fatouros</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Training</keyword>
  <keyword>Cell free plasma DNA</keyword>
  <keyword>Oxidative stress</keyword>
  <keyword>Performance</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03833973
org study id: SuPpOrt-UTH
nct id: NCT03833973
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Athletic training aims to increase and improve physical performance that is achieved through
      training overload combined with periods of rest and recovery. Overtraining syndrome (OTS) is
      associated with an imbalance between training and recovery. The symptoms associated with OTS
      vary between individuals and may reflect parasympathetic and/or sympathetic nervous system
      alterations as well as endocrine irregularities. The prevalence is not known, but it is
      usually reported among endurance athletes, such as cyclists, distance runners and
      triathletes. It appears that OTS represents a systemic inflammatory process with diffuse
      effects on the neurohormonal axis affecting host immunology and mood. Previous works, showed
      that cell-free DNA (cf-DNA) is correlated with the severity of excessive exercise-induced
      inflammation as well as with trauma and stroke severity suggesting that it might be used as a
      potential clinical marker for athletes with overtraining syndrome. Oxidative stress indices
      can be determined non-invasively and may reflect inflammatory responses after training
      suggesting that they could be used as clinical markers for the diagnosis of OTS. However,
      there are no available biomarkers to aid towards the diagnosis and/or prevention of OTS,
      except that of the persistence of unexplained underperformance despite an extensive recovery
      of the athlete. Therefore, the purpose of this study is to evaluate the potential of cf-DNA
      and selected oxidative stress variables as diagnostic biomarkers of OTS.
A total number of 15 elite-level runners (both male and female) and 80-100 soccer players
      (both male and female) will participate in the study.The day when participants (runners) will
      arrive at the lab early in the morning, after an overnight fast. They will have their blood
      pressure and orthostatic heart rate measured and they will also provide a blood sample.
      Immediately after participants' body composition will be assessed by dual energy X-ray
      absorptiometry (DXA). Then, they will perform the Meeusen test providing a second blood
      sample immediately after the test. During the subsequent 4-hour resting period, the
      participants followed by assessment of joint mobility, delayed onset of muscle soreness,
      flexibility and vertical jump performance after that lower limb peak torque by isokinetic
      dynamometer. A second Meeusen test will take place after the resting period with blood
      sampling post-testing. Then, participants will have a 3-hour rest, after which they will
      visit the lab again in order to perform the running economy testing protocol and a maximal
      lactate steady state test. Finally, participants will complete POMS-, quality of sleep- and
      symptomatology-related questionnaires and will be taught on how to complete dietary recalls.
      Over the subsequent 12-month period participants will provide the investigator with a
      detailed report of their training plan and a symptomatology questionnaire every month. These
      measurements take place for all participants in two different periods, in transitional
      period/baseline and in middle season (berore tha main race). If someone of participants
      manifest the symptoms of overtraining, they perform the protocol of measurements again. The
      day when participants (soccer players) will arrive at the lab early in the morning, after an
      overnight fast. They will have their blood pressure and orthostatic heart rate measured and
      they will also provide a blood sample. Immediately after participants' body composition will
      be assessed by dual energy X-ray absorptiometry (DXA). The participants followed by
      assessment of joint mobility, delayed onset of muscle soreness, flexibility and vertical jump
      performance after that lower limb peak torque by isokinetic dynamometer. After resting, they
      will measurement the maximum oxygen uptake in stress test on the aisle. The next days, in
      football players take place in field tests, will measure the Speed in 10, 30 meters, Yo-Yo
      IE2 (Intermittent Endurance 2), Yo-Yo IR2 (Intermittent Recovery 2) and Repeated Sprint
      Ability (RSA). Finally, participants (soccer players) will complete POMS-, quality of sleep-
      and symptomatology-related questionnaires and will be taught on how to complete dietary
      recalls.These measurements take place for all participants in two different periods, in
      transitional period/baseline and in middle season (berore tha main race). If someone of
      participants manifest the symptoms of overtraining, they perform the protocol again.
observational model: Cohort
time perspective: Prospective
measure: Change in cell free plasma DNA
time frame: At baseline, at six months and at twelve months
description: Cell free plasma DNA will be measured with real-time PCR in plasma samples.
measure: Change in Cortisol level
time frame: At baseline, at six months and at twelve months
description: Cortisol concentration will measured in serum
measure: Change in Testosterone level
time frame: At baseline, at six months and at twelve months
description: Testosterone concentration will be measured in serum
measure: Change in cytokine response
time frame: At baseline, at six months and at twelve months
description: Concentration of TNF-α, IL-6 and IL-10 will be measured in plasma.
measure: Change in creatine kinase in plasma
time frame: At baseline, at six months and at twelve months
description: Concentration of creatine kinase will be measured in plasma
measure: Change in uric acid in plasma
time frame: At baseline, at six months and at twelve months
description: Concentration of uric acid will be measured in plasma
measure: Change in protein carbonyls in blood
time frame: At baseline, at six months and at twelve months
description: Concentration of protein carbonyls will be measured in red blood cells
measure: Change in total antioxidant capacity
time frame: At baseline, at six months and at twelve months
description: Total antioxidant capacity will be measured in plasma
measure: Change in reduced glutathione in blood
time frame: At baseline, at six months and at twelve months
description: Concentration of reduced glutathione will be measured in in red blood cells
measure: Change in oxidized glutathione in blood
time frame: At baseline, at six months and at twelve months
description: Concentration of oxidized glutathione will be measured in red blood cells
measure: Change in catalase activity
time frame: At baseline, at six months and at twelve months
description: Catalase activity will be measured in red blood cells
measure: Change in malondialdehyde in blood
time frame: At baseline, at six months and at twelve months
description: Concentration of malondialdehyde will be measured in serum
measure: Change in blood lactate concentration
time frame: At baseline, at six months and at twelve months
description: Blood lactate concentration will be measured during a maximal lactate steady-state test.
measure: Change in peak torque
time frame: At baseline, at six months and at twelve months
description: Peak torque will be assessed on an isokinetic dynamometer at 60 degrees/sec
measure: Change in orthostatic heart rate.
time frame: At baseline, at six months and at twelve months
description: Heart rate will be measured in a resting position and following 15 seconds of standing by heart rate monitor.
measure: Change in jumping ability.
time frame: At baseline, at six months and at twelve months
description: Jumping ability will be assessed by measuring squat jump.
measure: Change in flexibility
time frame: At baseline, at six months and at twelve months
description: Flexibility will be assessed through the sit and reach test.
measure: Change in body composition.
time frame: At baseline, at six months and at twelve months
description: Body composition will be assessed by dual energy X-ray absorptiometry (DXA)
measure: Change in delay onset of muscle soreness (DOMS)
time frame: At baseline, at six months and at twelve months
description: DOMS will be assessed by muscle palpation while participants are laying , standing and after performing 3 squats.
measure: Change in complete blood count
time frame: At baseline, at six months and at twelve months
description: Complete blood count analysis will be performed on an automatic blood analyzer.
measure: Change in RSA
time frame: At baseline, at six months and at twelve months
description: 5 x 30 m sprints will be performed with 25 seconds rest in-between. Mean time for 5 sprints and fatigue index will be calculated.
measure: Change in Yo-Yo IE2
time frame: At baseline, at six months and at twelve months
description: Yo-Yo IE2 will be assessed using a standardized testing protocol.
measure: Change in Yo-Yo IR2
time frame: At baseline, at six months and at twelve months
description: Yo-Yo IR2 will be assessed using a standardized testing protocol.
measure: Change in Spreed
time frame: At baseline, at six months and at twelve months
description: Spreed will be assessed using a standardized testing protocol in 10 and 30 meters.
measure: Dietary intake
time frame: At baseline, at six months and at twelve months
description: Dietary intake will be assessed using 7-day diet recalls.
measure: Change in jumping ability.
time frame: At baseline, at six months and at twelve months
description: Jumping ability will be assessed by measuring counter-movement jump.
measure: Change in jumping ability.
time frame: At baseline, at six months and at twelve months
description: Jumping ability will be assessed by measuring drop jump.
arm group label: Runners
description: Long-distance runners, marathon runners, 5 km and 10 km runners, both female and male aged 20 - 40 years, participating in regular training and competitions.
arm group label: Soccer Players
description: High Level soccer players, both female and male aged 15-30, participating in all games
intervention type: Behavioral
intervention name: Overtraining Monitoring
description: Athletes will be thoroughly monitored (i.e. training workload, match activities or event/race performance, markers of inflammation and oxidative stress as well as cell-free DNA) throughout the season in order to establish novel biomarkers that could function as either predictors or diagnostic tools of overtraining.
arm group label: Runners
arm group label: Soccer Players
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vasiliki C Laschou, PhDc
role: Principal Investigator
affiliation: UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
last name: IOANNIS G FATOUROS, PhD
phone: +30 24310 47047
email: ifatouros@pe.uth.gr
last name: ATHANASIOS Z JAMURTAS, Prof
phone: +30 24310 47054
email: ajamurt@pe.uth.gr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University of Thessaly
investigator full name: Ioannis G. Fatouros
investigator title: Professor