<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/NCT01728675</url>
  </required_header>
  <id_info>
    <org_study_id>EUC-017</org_study_id>
    <secondary_id>EUC-019</secondary_id>
    <nct_id>NCT01728675</nct_id>
  </id_info>
  <brief_title>Eccentric Exercise and Oxidative Stress</brief_title>
  <official_title>The Effect of Eccentric Exercise on Oxidative Stress in the Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European University Cyprus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>European University Cyprus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present investigation is to compare the responses and adaptations of young&#xD;
      and elderly individuals to repeated eccentric exercise in regards to muscle function and&#xD;
      redox homeostasis in a side-by-side comparison.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the progress of analytic techniques and the refinement of study designs, striking&#xD;
      disagreement exists among studies regarding the influence of exercise on muscle function and&#xD;
      redox homeostasis in the elderly. A specific exercise protocol will be applied (the repeated&#xD;
      eccentric model) to produce long-lasting and extensive changes in redox biomarkers and to&#xD;
      examine more easily the potential effects of aging. Ten young men and ten elderly men will&#xD;
      underwent an isokinetic eccentric exercise session, which will be repeated after three weeks.&#xD;
      Muscle function indices and redox biomarkers will be assessed in urine, plasma or&#xD;
      erythrocytes pre exercise, immediately post exercise, 2 and 4 days post exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle torque (torque)</measure>
    <time_frame>Change in muscle torque from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion, ROM (degrees)</measure>
    <time_frame>Change in ROM from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Delayed onset muscle soreness, DOMS (scale 1-10)</measure>
    <time_frame>Change in DOMS from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatine kinase, CK (activity IU)</measure>
    <time_frame>Change in CK from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>F2-isoprostanes (pg/mg creatinine)</measure>
    <time_frame>Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein carbonyls (nmol/mg protein)</measure>
    <time_frame>Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glutathione, GSH (μmol/g Hb)</measure>
    <time_frame>Change in GSH from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catalase (U/g Hb)</measure>
    <time_frame>Change in catalase from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superoxide dismutase, SOD (U/g Hb)</measure>
    <time_frame>Change in SOD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glutathione peroxidase, GPx (U/g Hb)</measure>
    <time_frame>Change in GPx from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose-6-phosphate dehydrogenase, G6PD (U/g Hb)</measure>
    <time_frame>Change in G6PD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uric acid (mM)</measure>
    <time_frame>Change in uric acid from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin (μM)</measure>
    <time_frame>Change in albumin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubin (μM)</measure>
    <time_frame>Change in bilirubin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Aging</condition>
  <condition>Muscle Damage</condition>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>Young group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will underwent two isokinetic eccentric exercise sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elderly group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will underwent two isokinetic eccentric exercise sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Participants will perform two isokinetic eccentric exercise bouts</description>
    <arm_group_label>Elderly group</arm_group_label>
    <arm_group_label>Young group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subject provides written informed consent&#xD;
&#xD;
          -  physiological health profile&#xD;
&#xD;
          -  stable at their anthropometric characteristics for at least the last year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  muscle disease&#xD;
&#xD;
          -  prior history of musculoskeletal injury to the lower limbs&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  consumed any nutritional supplement the last 3 months&#xD;
&#xD;
          -  performed intense eccentric exercise the last 6 months&#xD;
&#xD;
          -  non Caucasian&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michalis G Nikolaidis, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Aristotle University Of Thessaloniki</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>European University Cyprus</name>
      <address>
        <city>Nicosia</city>
        <zip>1516</zip>
        <country>Cyprus</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cyprus</country>
  </location_countries>
  <reference>
    <citation>Nikolaidis MG, Kyparos A, Vrabas IS. F(2)-isoprostane formation, measurement and interpretation: the role of exercise. Prog Lipid Res. 2011 Jan;50(1):89-103. doi: 10.1016/j.plipres.2010.10.002. Epub 2010 Oct 15.</citation>
    <PMID>20951733</PMID>
  </reference>
  <reference>
    <citation>Nikolaidis MG, Jamurtas AZ. Blood as a reactive species generator and redox status regulator during exercise. Arch Biochem Biophys. 2009 Oct 15;490(2):77-84. doi: 10.1016/j.abb.2009.08.015. Epub 2009 Aug 25.</citation>
    <PMID>19712664</PMID>
  </reference>
  <reference>
    <citation>Nikolaidis MG, Kyparos A, Spanou C, Paschalis V, Theodorou AA, Vrabas IS. Redox biology of exercise: an integrative and comparative consideration of some overlooked issues. J Exp Biol. 2012 May 15;215(Pt 10):1615-25. doi: 10.1242/jeb.067470.</citation>
    <PMID>22539728</PMID>
  </reference>
  <reference>
    <citation>Theodorou AA, Nikolaidis MG, Paschalis V, Sakellariou GK, Fatouros IG, Koutedakis Y, Jamurtas AZ. Comparison between glucose-6-phosphate dehydrogenase-deficient and normal individuals after eccentric exercise. Med Sci Sports Exerc. 2010 Jun;42(6):1113-21. doi: 10.1249/MSS.0b013e3181c67ecd.</citation>
    <PMID>19997026</PMID>
  </reference>
  <reference>
    <citation>Panayiotou G, Paschalis V, Nikolaidis MG, Theodorou AA, Deli CK, Fotopoulou N, Fatouros IG, Koutedakis Y, Sampanis M, Jamurtas AZ. No adverse effects of statins on muscle function and health-related parameters in the elderly: an exercise study. Scand J Med Sci Sports. 2013 Oct;23(5):556-67. doi: 10.1111/j.1600-0838.2011.01437.x. Epub 2012 Jan 31.</citation>
    <PMID>22288788</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>European University Cyprus</investigator_affiliation>
    <investigator_full_name>Dr. Anastasios Theodorou</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>Aging</keyword>
  <keyword>Skeletal muscle</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Adaptation</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/NCT01728675
org study id: EUC-017
secondary id: EUC-019
nct id: NCT01728675
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the present investigation is to compare the responses and adaptations of young
      and elderly individuals to repeated eccentric exercise in regards to muscle function and
      redox homeostasis in a side-by-side comparison.
Despite the progress of analytic techniques and the refinement of study designs, striking
      disagreement exists among studies regarding the influence of exercise on muscle function and
      redox homeostasis in the elderly. A specific exercise protocol will be applied (the repeated
      eccentric model) to produce long-lasting and extensive changes in redox biomarkers and to
      examine more easily the potential effects of aging. Ten young men and ten elderly men will
      underwent an isokinetic eccentric exercise session, which will be repeated after three weeks.
      Muscle function indices and redox biomarkers will be assessed in urine, plasma or
      erythrocytes pre exercise, immediately post exercise, 2 and 4 days post exercise.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Muscle torque (torque)
time frame: Change in muscle torque from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Range of motion, ROM (degrees)
time frame: Change in ROM from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Delayed onset muscle soreness, DOMS (scale 1-10)
time frame: Change in DOMS from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Creatine kinase, CK (activity IU)
time frame: Change in CK from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: F2-isoprostanes (pg/mg creatinine)
time frame: Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Protein carbonyls (nmol/mg protein)
time frame: Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Glutathione, GSH (μmol/g Hb)
time frame: Change in GSH from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Catalase (U/g Hb)
time frame: Change in catalase from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Superoxide dismutase, SOD (U/g Hb)
time frame: Change in SOD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Glutathione peroxidase, GPx (U/g Hb)
time frame: Change in GPx from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Glucose-6-phosphate dehydrogenase, G6PD (U/g Hb)
time frame: Change in G6PD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Uric acid (mM)
time frame: Change in uric acid from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Albumin (μM)
time frame: Change in albumin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
measure: Bilirubin (μM)
time frame: Change in bilirubin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
arm group label: Young group
arm group type: Experimental
description: Participants will underwent two isokinetic eccentric exercise sessions
arm group label: Elderly group
arm group type: Experimental
description: Participants will underwent two isokinetic eccentric exercise sessions
intervention type: Other
intervention name: Exercise
description: Participants will perform two isokinetic eccentric exercise bouts
arm group label: Elderly group
arm group label: Young group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michalis G Nikolaidis, PhD
role: Study Chair
affiliation: Aristotle University Of Thessaloniki
facility: 
country: Cyprus
citation: Nikolaidis MG, Kyparos A, Vrabas IS. F(2)-isoprostane formation, measurement and interpretation: the role of exercise. Prog Lipid Res. 2011 Jan;50(1):89-103. doi: 10.1016/j.plipres.2010.10.002. Epub 2010 Oct 15.
PMID: 20951733
citation: Nikolaidis MG, Jamurtas AZ. Blood as a reactive species generator and redox status regulator during exercise. Arch Biochem Biophys. 2009 Oct 15;490(2):77-84. doi: 10.1016/j.abb.2009.08.015. Epub 2009 Aug 25.
PMID: 19712664
citation: Nikolaidis MG, Kyparos A, Spanou C, Paschalis V, Theodorou AA, Vrabas IS. Redox biology of exercise: an integrative and comparative consideration of some overlooked issues. J Exp Biol. 2012 May 15;215(Pt 10):1615-25. doi: 10.1242/jeb.067470.
PMID: 22539728
citation: Theodorou AA, Nikolaidis MG, Paschalis V, Sakellariou GK, Fatouros IG, Koutedakis Y, Jamurtas AZ. Comparison between glucose-6-phosphate dehydrogenase-deficient and normal individuals after eccentric exercise. Med Sci Sports Exerc. 2010 Jun;42(6):1113-21. doi: 10.1249/MSS.0b013e3181c67ecd.
PMID: 19997026
citation: Panayiotou G, Paschalis V, Nikolaidis MG, Theodorou AA, Deli CK, Fotopoulou N, Fatouros IG, Koutedakis Y, Sampanis M, Jamurtas AZ. No adverse effects of statins on muscle function and health-related parameters in the elderly: an exercise study. Scand J Med Sci Sports. 2013 Oct;23(5):556-67. doi: 10.1111/j.1600-0838.2011.01437.x. Epub 2012 Jan 31.
PMID: 22288788
responsible party type: Principal Investigator
investigator affiliation: European University Cyprus
investigator full name: Dr. Anastasios Theodorou
investigator title: Researcher