<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/NCT01673958</url>
  </required_header>
  <id_info>
    <org_study_id>EUC-011</org_study_id>
    <nct_id>NCT01673958</nct_id>
  </id_info>
  <brief_title>Stair Descending vs. Stair Ascending Exercise</brief_title>
  <official_title>The Effect of Stair Descending and Stair Ascending Exercise on Muscle Strength and Performance: the SmartEscalator Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European University Cyprus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <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 aim of the present project is to compare the acute and chronic effect of stair descending&#xD;
      versus stair ascending exercise on muscle damage and performance in elderly males with&#xD;
      chronic heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design:&#xD;
&#xD;
      Twelve elderly males with chronic heart failure, New York Heart Association class I-II, will&#xD;
      participate in this study. Participants will be allocated into two equally-sized groups: a&#xD;
      stair descending group (n = 6) and a stair ascending group (n = 6). At the beginning of the&#xD;
      study, the volunteers will perform an acute bout of stair descending or stair ascending&#xD;
      exercise on an automatic escalator (4 sets of 3 min each, speed will be set at 45&#xD;
      steps∙min-1). Step height will be 20.5 mm. Before and at day 2 post exercise, physiologic&#xD;
      measurements will be performed and blood samples will be collected. Then, participants will&#xD;
      carry out six weeks of stair descending or ascending training consisting of three exercise&#xD;
      sessions per week (the first two weeks the speed will be set at 45 steps∙min-1, the next two&#xD;
      weeks at 50 steps∙min-1 and the last two weeks at 55 steps∙min-1 for both groups). Afterward,&#xD;
      they will repeat the acute stair descending or ascending protocol, as carried out at the&#xD;
      beginning of the study, and the same physiologic measurements will be performed and blood&#xD;
      samples will be collected.&#xD;
&#xD;
      Measurements:&#xD;
&#xD;
      Isometric (at 90 knee flexion), concentric and eccentric peak torque at 60o∙s-1of quadriceps&#xD;
      femoris, pain-free range of motion, delayed onset muscle soreness and creatine kinase will be&#xD;
      measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle strength (torque)</measure>
    <time_frame>Change from baseline in muscle strength at day 2 post exercise at the first and sixth week of training</time_frame>
    <description>An isokinetic dynamometer (Cybex, Ronkonkoma, NY) will be used for the measurement of isometric, eccentric and concentric knee extensor peak torque at 90° knee flexion. The average of the three best maximal voluntary contractions with their dominant leg will be recorded. In order to ensure that the subjects provide their maximal effort, the measurements will be repeated if the difference between the lower and the higher torque value exceeded 10%. There will be two minutes rest between isometric efforts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain free range of motion (degrees)</measure>
    <time_frame>Before and at day 2 post exercise at the first and sixth week of training</time_frame>
    <description>The assessment of pain-free ROM will be performed manually using the the isokinetic dynamometer. The investigator will move the calf at a very low angular velocity from 0 knee extension to the position where the subject will feel any discomfort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatine kinase, CK (activity IU)</measure>
    <time_frame>Before and at day 2 post exercise at the first and sixth week of training</time_frame>
    <description>CK activity will be measured as a general indicator of muscle damage.It will be measured in a Cobas Integra Plus 400 chemistry analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delayed onset muscle soreness, DOMS (scale 1-10)</measure>
    <time_frame>Before and at day 2 post exercise at the first and sixth week of training</time_frame>
    <description>Each participant will assess delayed onset muscle soreness (DOMS) during squat movement (90o knee flexion) and perceived soreness will be rated on a scale ranging from 1 (normal) to 10 (very sore).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Aging</condition>
  <condition>Heart Failure</condition>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Stair descending group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stair descending exercise. Participants will carry out six weeks of stair descending training consisting of three exercise sessions per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stair ascending group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stair ascending exercise. Participants will carry out six weeks of stair descending training consisting of three exercise sessions per week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Comparison between stair descending and stair ascending training</description>
    <arm_group_label>Stair ascending group</arm_group_label>
    <arm_group_label>Stair descending group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic heart failure (New York Heart Association class I-II)&#xD;
&#xD;
          -  subject provides written informed consent&#xD;
&#xD;
          -  personal physician of the participants provides written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoker&#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>60 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Panayiotou, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Research Centre, European University Cyprus</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>Paschalis V, Nikolaidis MG, Theodorou AA, Panayiotou G, Fatouros IG, Koutedakis Y, Jamurtas AZ. A weekly bout of eccentric exercise is sufficient to induce health-promoting effects. Med Sci Sports Exerc. 2011 Jan;43(1):64-73. doi: 10.1249/MSS.0b013e3181e91d90.</citation>
    <PMID>20508540</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 24, 2012</last_update_submitted>
  <last_update_submitted_qc>August 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 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>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Eccentric exercise</keyword>
  <keyword>Aging</keyword>
  <keyword>Heart failure</keyword>
  <keyword>Muscle strength loss</keyword>
  <keyword>Sarcopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT01673958
org study id: EUC-011
nct id: NCT01673958
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The aim of the present project is to compare the acute and chronic effect of stair descending
      versus stair ascending exercise on muscle damage and performance in elderly males with
      chronic heart failure.
Study design:

      Twelve elderly males with chronic heart failure, New York Heart Association class I-II, will
      participate in this study. Participants will be allocated into two equally-sized groups: a
      stair descending group (n = 6) and a stair ascending group (n = 6). At the beginning of the
      study, the volunteers will perform an acute bout of stair descending or stair ascending
      exercise on an automatic escalator (4 sets of 3 min each, speed will be set at 45
      steps∙min-1). Step height will be 20.5 mm. Before and at day 2 post exercise, physiologic
      measurements will be performed and blood samples will be collected. Then, participants will
      carry out six weeks of stair descending or ascending training consisting of three exercise
      sessions per week (the first two weeks the speed will be set at 45 steps∙min-1, the next two
      weeks at 50 steps∙min-1 and the last two weeks at 55 steps∙min-1 for both groups). Afterward,
      they will repeat the acute stair descending or ascending protocol, as carried out at the
      beginning of the study, and the same physiologic measurements will be performed and blood
      samples will be collected.

      Measurements:

      Isometric (at 90 knee flexion), concentric and eccentric peak torque at 60o∙s-1of quadriceps
      femoris, pain-free range of motion, delayed onset muscle soreness and creatine kinase will be
      measured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Muscle strength (torque)
time frame: Change from baseline in muscle strength at day 2 post exercise at the first and sixth week of training
description: An isokinetic dynamometer (Cybex, Ronkonkoma, NY) will be used for the measurement of isometric, eccentric and concentric knee extensor peak torque at 90° knee flexion. The average of the three best maximal voluntary contractions with their dominant leg will be recorded. In order to ensure that the subjects provide their maximal effort, the measurements will be repeated if the difference between the lower and the higher torque value exceeded 10%. There will be two minutes rest between isometric efforts.
measure: Pain free range of motion (degrees)
time frame: Before and at day 2 post exercise at the first and sixth week of training
description: The assessment of pain-free ROM will be performed manually using the the isokinetic dynamometer. The investigator will move the calf at a very low angular velocity from 0 knee extension to the position where the subject will feel any discomfort.
measure: Creatine kinase, CK (activity IU)
time frame: Before and at day 2 post exercise at the first and sixth week of training
description: CK activity will be measured as a general indicator of muscle damage.It will be measured in a Cobas Integra Plus 400 chemistry analyzer.
measure: Delayed onset muscle soreness, DOMS (scale 1-10)
time frame: Before and at day 2 post exercise at the first and sixth week of training
description: Each participant will assess delayed onset muscle soreness (DOMS) during squat movement (90o knee flexion) and perceived soreness will be rated on a scale ranging from 1 (normal) to 10 (very sore).
arm group label: Stair descending group
arm group type: Experimental
description: Stair descending exercise. Participants will carry out six weeks of stair descending training consisting of three exercise sessions per week.
arm group label: Stair ascending group
arm group type: Experimental
description: Stair ascending exercise. Participants will carry out six weeks of stair descending training consisting of three exercise sessions per week.
intervention type: Other
intervention name: Exercise
description: Comparison between stair descending and stair ascending training
arm group label: Stair ascending group
arm group label: Stair descending group
criteria: 
gender: Male
minimum age: 60 Years
maximum age: 70 Years
healthy volunteers: No
last name: George Panayiotou, PhD
role: Study Chair
affiliation: Research Centre, European University Cyprus
facility: 
country: Cyprus
citation: Paschalis V, Nikolaidis MG, Theodorou AA, Panayiotou G, Fatouros IG, Koutedakis Y, Jamurtas AZ. A weekly bout of eccentric exercise is sufficient to induce health-promoting effects. Med Sci Sports Exerc. 2011 Jan;43(1):64-73. doi: 10.1249/MSS.0b013e3181e91d90.
PMID: 20508540
responsible party type: Principal Investigator
investigator affiliation: European University Cyprus
investigator full name: Dr. Anastasios Theodorou
investigator title: Principal investigator
mesh term: Sarcopenia
mesh term: Heart Failure