<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/NCT01728415</url>
  </required_header>
  <id_info>
    <org_study_id>2012/1459</org_study_id>
    <secondary_id>126/12-303.0</secondary_id>
    <nct_id>NCT01728415</nct_id>
  </id_info>
  <brief_title>Effects of High-intensity Interval Training in Patients in Hemodialysis</brief_title>
  <acronym>OsloExDia</acronym>
  <official_title>Effects of High-intensity Interval Training in Patients in Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Fund for Postgraduate Training in Physiotherapy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects of high intensity interval training&#xD;
      compared to moderate exercise training and a control group on exercise capacity and quality&#xD;
      of life in patients with end stage renal disease on hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak oxygen uptake</measure>
    <time_frame>baseline, 16 weeks</time_frame>
    <description>Canges from baseline in peak oxygen uptake at 16 weeks</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Chronic Renal Disease</condition>
  <arm_group>
    <arm_group_label>A: Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High intensity interval exercise training (3 x 3 minutes of intensity abow 85% og Heart rate peak)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B: Execise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Moderate continuous exercise training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C: Controll</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care without exercise training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise</intervention_name>
    <description>Group A: high intensity exercise training Group B: moderate intensity exercise training C: Control group</description>
    <arm_group_label>A: Exercise</arm_group_label>
    <arm_group_label>B: Execise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients on hemodialysis ≥ 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute infection&#xD;
&#xD;
          -  Systolic BP&gt;180 mmHG or diabolic BP&gt;105 mmHG&#xD;
&#xD;
          -  Unstable angina pectoris&#xD;
&#xD;
          -  Serious rhythm disturbances&#xD;
&#xD;
          -  Hyperkalemic (&gt; 6 mmol/L),&#xD;
&#xD;
          -  Unstable diabetes mellitus&#xD;
&#xD;
          -  Wheelchair&#xD;
&#xD;
          -  Dialyses access on lower extremities&#xD;
&#xD;
          -  Haemoglobin &lt; 9 g/dl&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Birgitta Blakstad Nilsson, PhD</last_name>
    <phone>+4793210913</phone>
    <email>b.b.nilsson@medisin.uio.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aud Eldrid Stenehjem, PhD</last_name>
    <phone>+4790667069</phone>
    <email>uxaust@ous-hf.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <state>Postboks 4950 Nydalen</state>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Birgitta Blakstad Nilsson, PhD</last_name>
      <phone>+47 93210913</phone>
    </contact>
    <investigator>
      <last_name>Heidi B Næss</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>September 19, 2014</last_update_submitted>
  <last_update_submitted_qc>September 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Birgitta Blakstad Nilsson, PhD</investigator_full_name>
    <investigator_title>The Oslo ExDia-study</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Hemodialysis</keyword>
  <keyword>Physical therapy</keyword>
  <keyword>high-intensity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Kidney Failure, Chronic</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/NCT01728415
org study id: 2012/1459
secondary id: 126/12-303.0
nct id: NCT01728415
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the effects of high intensity interval training
      compared to moderate exercise training and a control group on exercise capacity and quality
      of life in patients with end stage renal disease on hemodialysis.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Peak oxygen uptake
time frame: baseline, 16 weeks
description: Canges from baseline in peak oxygen uptake at 16 weeks
arm group label: A: Exercise
arm group type: Experimental
description: High intensity interval exercise training (3 x 3 minutes of intensity abow 85% og Heart rate peak)
arm group label: B: Execise
arm group type: Active Comparator
description: Moderate continuous exercise training
arm group label: C: Controll
arm group type: No Intervention
description: Usual care without exercise training
intervention type: Other
intervention name: exercise
description: Group A: high intensity exercise training Group B: moderate intensity exercise training C: Control group
arm group label: A: Exercise
arm group label: B: Execise
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Birgitta Blakstad Nilsson, PhD
phone: +4793210913
email: b.b.nilsson@medisin.uio.no
last name: Aud Eldrid Stenehjem, PhD
phone: +4790667069
email: uxaust@ous-hf.no
facility: 
status: Recruiting
contact: 
investigator: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Birgitta Blakstad Nilsson, PhD
investigator title: The Oslo ExDia-study
mesh term: Renal Insufficiency, Chronic
mesh term: Kidney Failure, Chronic