<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/NCT03027778</url>
  </required_header>
  <id_info>
    <org_study_id>12-309 GEN</org_study_id>
    <nct_id>NCT03027778</nct_id>
  </id_info>
  <brief_title>Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population</brief_title>
  <official_title>Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling&#xD;
      exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and&#xD;
      2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic&#xD;
      parameters 4 months after finishing the exercise intervention (8 months after study&#xD;
      initiation).&#xD;
&#xD;
      The investigators also aim to examine the impact of intradialytic pedaling exercise on&#xD;
      general health, anthropometric measures, physical function, and routine laboratory blood&#xD;
      markers as secondary outcome measures, as well as to assess feasibility, safety and adverse&#xD;
      events associated with the intradialytic pedalling exercise.&#xD;
&#xD;
      Recruitment of more participants in the future will be considered if warranted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Change in non-invasive measures of arterial stiffness using applanation tonometry.</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in gait speed using a 6 meter walk course and timer.</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in grip strength using a hand dynamometer.</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and adverse events.</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in peripheral and central blood pressure using a oscillometric cuff-based approach.</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in total cholesterol levels</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in triglyceride levels</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in high density lipoprotein cholesterol levels</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in low-density lipoprotein cholesterol levels</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
    <description>Calculated using the Friedewald equation based on total cholesterol and high density lipoprotein cholesterol levels</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in hemoglobin levels</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in leukocyte levels</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in platelet levels</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in albumin levels</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum electrolyte levels</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in phosphate levels</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in ferritin levels</measure>
    <time_frame>4 months and 8 months after study initiation</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Chronic Kidney Disease Requiring Chronic Dialysis</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will engage in pedalling exercise 3 times per week during the first 2 hours of dialysis treatment for the duration of 4 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants receive their usual dialysis for the duration of 4 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with end-stage renal disease (stage 5 CKD), who were on a stable in-center&#xD;
             hemodialysis regimen (approximately 4 hours 3 times per week) for ≥ 12 weeks prior to&#xD;
             recruitment&#xD;
&#xD;
          -  A cardiac evaluation was required within the last year to ensure adequate cardiac&#xD;
             function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any physical or psychological disability that would impact study participation, such&#xD;
             as severe cerebrovascular disease (e.g., hemiparesis, cerebellar ataxia, etc.) or&#xD;
             dementia&#xD;
&#xD;
          -  Serum intact parathyroid hormone(iPTH)&gt;250 pmol/L within 30 days prior to screening&#xD;
             visit&#xD;
&#xD;
          -  Dysrhythmia or severe cardiac disease, such as congestive heart failure (CHF) Class&#xD;
             III-IV, or unstable cardiovascular disease within 90 days prior to recruitment&#xD;
&#xD;
          -  Severe peripheral arterial disease&#xD;
&#xD;
          -  Severe hyperkalemia (&gt;6.5 milliequivalent/L) consistently the last 2 weeks&#xD;
&#xD;
          -  Current active cancer (excluding basal cell carcinoma of the skin)&#xD;
&#xD;
          -  Poorly controlled hypertension (post-dialytic systolic blood pressure ≥ 160mmHg or&#xD;
             diastolic blood pressure≥ 100 mmHg) within 4 weeks prior to recruitment&#xD;
&#xD;
          -  Anticipated living donor kidney transplant or any other planned major surgery over the&#xD;
             study duration&#xD;
&#xD;
          -  History of poor treatment adherence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stella S Daskalopoulou, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>March 20, 2018</last_update_submitted>
  <last_update_submitted_qc>March 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Dr. Stella Daskalopoulou</investigator_full_name>
    <investigator_title>Associate Professor in Medicine</investigator_title>
  </responsible_party>
  <keyword>arterial stiffness</keyword>
  <keyword>hemodialysis</keyword>
  <keyword>intradialytic pedalling exercise</keyword>
  <keyword>carotid-femoral pulse wave velocity</keyword>
  <keyword>chronic kidney disease</keyword>
  <keyword>hemodynamics</keyword>
  <keyword>augmentation index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03027778
org study id: 12-309 GEN
nct id: NCT03027778
lead sponsor: 
has dmc: Yes
The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling
      exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and
      2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic
      parameters 4 months after finishing the exercise intervention (8 months after study
      initiation).

      The investigators also aim to examine the impact of intradialytic pedaling exercise on
      general health, anthropometric measures, physical function, and routine laboratory blood
      markers as secondary outcome measures, as well as to assess feasibility, safety and adverse
      events associated with the intradialytic pedalling exercise.

      Recruitment of more participants in the future will be considered if warranted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in non-invasive measures of arterial stiffness using applanation tonometry.
time frame: 4 months and 8 months after study initiation
measure: Change in gait speed using a 6 meter walk course and timer.
time frame: 4 months and 8 months after study initiation
measure: Change in grip strength using a hand dynamometer.
time frame: 4 months and 8 months after study initiation
measure: Safety and adverse events.
time frame: 8 months
measure: Change in peripheral and central blood pressure using a oscillometric cuff-based approach.
time frame: 4 months and 8 months after study initiation
measure: Change in total cholesterol levels
time frame: 4 months and 8 months after study initiation
measure: Change in triglyceride levels
time frame: 4 months and 8 months after study initiation
measure: Change in high density lipoprotein cholesterol levels
time frame: 4 months and 8 months after study initiation
measure: Change in low-density lipoprotein cholesterol levels
time frame: 4 months and 8 months after study initiation
description: Calculated using the Friedewald equation based on total cholesterol and high density lipoprotein cholesterol levels
measure: Change in hemoglobin levels
time frame: 4 months and 8 months after study initiation
measure: Change in leukocyte levels
time frame: 4 months and 8 months after study initiation
measure: Change in platelet levels
time frame: 4 months and 8 months after study initiation
measure: Change in albumin levels
time frame: 4 months and 8 months after study initiation
measure: Change in serum electrolyte levels
time frame: 4 months and 8 months after study initiation
measure: Change in phosphate levels
time frame: 4 months and 8 months after study initiation
measure: Change in ferritin levels
time frame: 4 months and 8 months after study initiation
arm group label: Exercise
arm group type: Experimental
description: Participants will engage in pedalling exercise 3 times per week during the first 2 hours of dialysis treatment for the duration of 4 months.
arm group label: Usual care
arm group type: No Intervention
description: Participants receive their usual dialysis for the duration of 4 months.
intervention type: Other
intervention name: Exercise
description: Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months
arm group label: Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stella S Daskalopoulou, MD, PhD
role: Principal Investigator
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Dr. Stella Daskalopoulou
investigator title: Associate Professor in Medicine
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No