<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/NCT02205944</url>
  </required_header>
  <id_info>
    <org_study_id>CAPCR-ID: 13-6763-AE</org_study_id>
    <nct_id>NCT02205944</nct_id>
  </id_info>
  <brief_title>Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes</brief_title>
  <official_title>The Impact of Exercise on Vascular Remodeling, Arteriovenous Fistula Creation and Use in Patients With Chronic Kidney Disease: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to determine whether two different types of forearm&#xD;
      exercise, performed before fistula creation surgery, can improve surgery success and fistula&#xD;
      maturation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double blinded controlled trial to study the impact of handgrip&#xD;
      exercise prior to surgical creation of hemodialysis fistula on vascular remodelling and&#xD;
      fistula maturation in chronic kidney disease patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Late dialysis suitability failure</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Late dialysis suitability failure is a fistula that, despite radiological or surgical intervention, cannot be used successfully for dialysis by the sixth month following its creation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of intra-access flow and vascular diameters at predetermined distances from the fistula anastomosis; arterial stiffness and endothelial function on a randomly determined sub sample of patients.</measure>
    <time_frame>Baseline, week 9 and week 11</time_frame>
    <description>Ultrasound measurements using duplex ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels</measure>
    <time_frame>Baseline, week 9 and week 11</time_frame>
    <description>cGMP and NO will be sampled in blood plasma collected immediately prior to ultrasound assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fistula maturation</measure>
    <time_frame>6 weeks after surgery</time_frame>
    <description>A fistula will be deemed mature if either criterion are met: 1) the National Kidney Foundation Disease Outcomes Quality Initiative 'rule of six' , or 2) the draining vein diameter is &gt; 4 mm with intra-access flows &gt; 500 ml/min AND an experienced hemodialysis nurse, blinded to group allocation, deems maturation to have occurred.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive routine vascular access pre-op teaching and care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 (Normal Exercise Group): progressive handgrip exercise&#xD;
Group 2 (Restricted Blood Flow Exercise Group): progressive handgrip exercise with controlled tourniquet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Progressive Handgrip Exercise</intervention_name>
    <description>Group 1 (Normal Exercise Group): Daily, at home for 20 minutes using an adjustable handgrip trainer up to 8 weeks prior to a scheduled surgery for fistula creation. The exercise intensity is tailored using the Borg CR100 scale (Borg &amp; Borg, 2001).&#xD;
Group 2 (Restricted Blood Flow Exercise Group): Same as the exercise performed by Group 1 with controlled tourniquet.</description>
    <arm_group_label>Normal Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult (age&gt;18 years old) with chronic kidney disease&#xD;
&#xD;
          2. Hemodialysis is their renal replacement therapy (RRT) modality&#xD;
&#xD;
          3. Deemed eligible for an arteriovenous fistula&#xD;
&#xD;
          4. Anticipated RRT start &lt; 3 months (from the time of vascular surgery assessment) if&#xD;
             predialysis&#xD;
&#xD;
          5. Scheduled surgical creation of fistula aniticpated &gt;= 8 weeks&#xD;
&#xD;
          6. Able to follow instructions for an exercise intervention&#xD;
&#xD;
          7. Able to provide informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Life expectancy &lt; 6 months&#xD;
&#xD;
          2. Need for urgent vascular access (i.e. &lt;4 weeks)&#xD;
&#xD;
          3. Pre-existing fistula distal to site of newly scheduled fistula&#xD;
&#xD;
          4. Ipsilateral central stenosis or occlusions not amenable to correction&#xD;
&#xD;
          5. Contraindications or unable to perform handgrip exercise&#xD;
&#xD;
               -  Unable to withstand transiently raised systolic blood pressure (SBP) by 35 mmHg,&#xD;
                  and diastolic (DBP) by 25 mmHg&#xD;
&#xD;
               -  severe upper extremity arthritis or other pain&#xD;
&#xD;
          6. Contraindications to general exercise&#xD;
&#xD;
               -  Poorly controlled blood pressure - SBP&gt;180, DBP&gt;90; SBP&lt;110, DBP&lt;50&#xD;
&#xD;
               -  NYHC IV heart failure&#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>Charmaine Lok, MD, FRCPC, MSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chris Chan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jamie Macdonald, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bangor University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Cherney, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cathy Forrester, RN</last_name>
    <phone>416-340-4748</phone>
    <email>Cathy.Forrester@uhn.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Toronto General Hospital - UHN</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 4, 2016</last_update_submitted>
  <last_update_submitted_qc>July 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
    <investigator_full_name>Charmaine Lok</investigator_full_name>
    <investigator_title>Professor of Medicine, University of Toronto</investigator_title>
  </responsible_party>
  <keyword>chronic kidney disease</keyword>
  <keyword>hemodialysis</keyword>
  <keyword>vascular access</keyword>
  <keyword>arteriovenous fistula</keyword>
  <keyword>forearm exercise</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>
    <mesh_term>Arteriovenous Fistula</mesh_term>
    <mesh_term>Fistula</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/NCT02205944
org study id: CAPCR-ID: 13-6763-AE
nct id: NCT02205944
lead sponsor: 
has dmc: No
The purpose of this research study is to determine whether two different types of forearm
      exercise, performed before fistula creation surgery, can improve surgery success and fistula
      maturation.
This is a randomized, double blinded controlled trial to study the impact of handgrip
      exercise prior to surgical creation of hemodialysis fistula on vascular remodelling and
      fistula maturation in chronic kidney disease patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Late dialysis suitability failure
time frame: 6 months after surgery
description: Late dialysis suitability failure is a fistula that, despite radiological or surgical intervention, cannot be used successfully for dialysis by the sixth month following its creation.
measure: Change of intra-access flow and vascular diameters at predetermined distances from the fistula anastomosis; arterial stiffness and endothelial function on a randomly determined sub sample of patients.
time frame: Baseline, week 9 and week 11
description: Ultrasound measurements using duplex ultrasonography
measure: Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels
time frame: Baseline, week 9 and week 11
description: cGMP and NO will be sampled in blood plasma collected immediately prior to ultrasound assessment
measure: Fistula maturation
time frame: 6 weeks after surgery
description: A fistula will be deemed mature if either criterion are met: 1) the National Kidney Foundation Disease Outcomes Quality Initiative 'rule of six' , or 2) the draining vein diameter is > 4 mm with intra-access flows > 500 ml/min AND an experienced hemodialysis nurse, blinded to group allocation, deems maturation to have occurred.
arm group label: Control Group
arm group type: No Intervention
description: The control group will receive routine vascular access pre-op teaching and care.
arm group label: Normal Exercise Group
arm group type: Experimental
description: Group 1 (Normal Exercise Group): progressive handgrip exercise
Group 2 (Restricted Blood Flow Exercise Group): progressive handgrip exercise with controlled tourniquet
intervention type: Other
intervention name: Progressive Handgrip Exercise
description: Group 1 (Normal Exercise Group): Daily, at home for 20 minutes using an adjustable handgrip trainer up to 8 weeks prior to a scheduled surgery for fistula creation. The exercise intensity is tailored using the Borg CR100 scale (Borg & Borg, 2001).
Group 2 (Restricted Blood Flow Exercise Group): Same as the exercise performed by Group 1 with controlled tourniquet.
arm group label: Normal Exercise Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Charmaine Lok, MD, FRCPC, MSC
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Chris Chan, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Jamie Macdonald, PhD
role: Principal Investigator
affiliation: Bangor University
last name: David Cherney, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Cathy Forrester, RN
phone: 416-340-4748
email: Cathy.Forrester@uhn.ca
facility: 
status: Recruiting
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University Health Network, Toronto
investigator full name: Charmaine Lok
investigator title: Professor of Medicine, University of Toronto
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Arteriovenous Fistula
mesh term: Fistula