<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/NCT02213770</url>
  </required_header>
  <id_info>
    <org_study_id>2014/872/REK sør-øst C</org_study_id>
    <nct_id>NCT02213770</nct_id>
  </id_info>
  <brief_title>Long Term Effect of High-intensity Training After Heart Transplantation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Health Association</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>
      High-intensity training (HIT) has repeatedly been documented to have superior positive&#xD;
      effects compared to moderate exercise in patients with coronary heart disease and heart&#xD;
      failure. Since heart transplant recipients (HTx), have a denervated heart with different&#xD;
      respond to exercise, HIT has previously not been introduced among these patients.&#xD;
      Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found&#xD;
      that this form of exercise also was highly effective and safe in long term HTx with&#xD;
      clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and&#xD;
      even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we&#xD;
      ask the following questions in this follow-up study:&#xD;
&#xD;
        1. Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study&#xD;
           period continue during long term follow up (5 years)?&#xD;
&#xD;
        2. Is the intervention group more physical active after HIT compared to the control group?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mean VO2peak in the intervention group and control group</measure>
    <time_frame>5 years after start of inclusion in RCT (TEX). One measurment.</time_frame>
    <description>We will use the same test protocol as the TEX- study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>How many has progression of cardiac allograft vasculopathy in the intervention group and control group.</measure>
    <time_frame>5 years after inclusion in RCT (TEX study).</time_frame>
    <description>Progression of vasculopathy will be studied with IVUS technique, and compared with IVUS pictures from TEX.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean muscle capacity in the intervention group and control group.</measure>
    <time_frame>5 years after inclusion in RCT, TEX study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>5 years after inclusion in TEX- study.</time_frame>
    <description>We will use validated questionnaires to estimate quality of life and to evaluate depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in activity level between groups</measure>
    <time_frame>5 years after inclusion i RCT, TEX study.</time_frame>
    <description>To estimate activity the study population will fill out a validated questionnaire about physical activity, and they will wear a physical activity monitor at home for one week.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>Heart Transplant Recipients</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <description>Group that followed high- intensity interval training program in TEX study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Followed up on a regular basis for HTx recipients in Norway.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blodsamples from the patients will be studied:&#xD;
&#xD;
      Standard samples: RBC, WBC, plates, CRP, kreatinin, urea, liver tests, thyorid gland tests,&#xD;
      lipid profile, fasting- glucose og hba1c, Pro BNP, troponin T, uric acid.&#xD;
&#xD;
      Supplement: Inflammation cytokines/chemokines such as TNF alfa, sTNFR2 og IL-6, IL-10, MCP-1&#xD;
      og IL-8. Growth factors and inhibitors for innervation. Markers for endothelial function;&#xD;
      endotelin and von- Willebrand faktor and anti- trombotic factors; fibrinogen, plasminogen&#xD;
      activator inhibitor-1.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The TEX population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stable situation&#xD;
&#xD;
          -  optimal medical treatment&#xD;
&#xD;
          -  written concent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable situation,&#xD;
&#xD;
          -  infections (open wounds or skin diseases),&#xD;
&#xD;
          -  physical conditions that prevents participation,&#xD;
&#xD;
          -  or other injuries/ diseases who are contraindicated with training.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Gullestad, professor</last_name>
    <role>Study Director</role>
    <affiliation>OUS- kardiologisk avdeling</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OUS- Rikshospitalet</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Nytroen K, Myers J, Chan KN, Geiran OR, Gullestad L. Chronotropic responses to exercise in heart transplant recipients: 1-yr follow-up. Am J Phys Med Rehabil. 2011 Jul;90(7):579-88. doi: 10.1097/PHM.0b013e31821f711d.</citation>
    <PMID>21765276</PMID>
  </results_reference>
  <results_reference>
    <citation>Nytroen K, Rustad LA, Gude E, Hallen J, Fiane AE, Rolid K, Holm I, Aakhus S, Gullestad L. Muscular exercise capacity and body fat predict VO(2peak) in heart transplant recipients. Eur J Prev Cardiol. 2014 Jan;21(1):21-9. doi: 10.1177/2047487312450540. Epub 2012 Jun 1.</citation>
    <PMID>22659939</PMID>
  </results_reference>
  <results_reference>
    <citation>Nytroen K, Rustad LA, Erikstad I, Aukrust P, Ueland T, Lekva T, Gude E, Wilhelmsen N, Hervold A, Aakhus S, Gullestad L, Arora S. Effect of high-intensity interval training on progression of cardiac allograft vasculopathy. J Heart Lung Transplant. 2013 Nov;32(11):1073-80. doi: 10.1016/j.healun.2013.06.023. Epub 2013 Jul 29.</citation>
    <PMID>23906899</PMID>
  </results_reference>
  <results_reference>
    <citation>Nytroen K, Rustad LA, Aukrust P, Ueland T, Hallen J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Transplant. 2012 Nov;12(11):3134-42. doi: 10.1111/j.1600-6143.2012.04221.x. Epub 2012 Aug 17.</citation>
    <PMID>22900793</PMID>
  </results_reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>January 22, 2016</last_update_submitted>
  <last_update_submitted_qc>January 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Marianne Yardley</investigator_full_name>
    <investigator_title>Cand med</investigator_title>
  </responsible_party>
  <!-- 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/NCT02213770
org study id: 2014/872/REK sør-øst C
nct id: NCT02213770
lead sponsor: 
collaborator: 
has dmc: No
High-intensity training (HIT) has repeatedly been documented to have superior positive
      effects compared to moderate exercise in patients with coronary heart disease and heart
      failure. Since heart transplant recipients (HTx), have a denervated heart with different
      respond to exercise, HIT has previously not been introduced among these patients.
      Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found
      that this form of exercise also was highly effective and safe in long term HTx with
      clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and
      even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we
      ask the following questions in this follow-up study:

        1. Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study
           period continue during long term follow up (5 years)?

        2. Is the intervention group more physical active after HIT compared to the control group?
observational model: Case-Crossover
time perspective: Cross-Sectional
measure: mean VO2peak in the intervention group and control group
time frame: 5 years after start of inclusion in RCT (TEX). One measurment.
description: We will use the same test protocol as the TEX- study.
measure: How many has progression of cardiac allograft vasculopathy in the intervention group and control group.
time frame: 5 years after inclusion in RCT (TEX study).
description: Progression of vasculopathy will be studied with IVUS technique, and compared with IVUS pictures from TEX.
measure: Mean muscle capacity in the intervention group and control group.
time frame: 5 years after inclusion in RCT, TEX study.
measure: Quality of life
time frame: 5 years after inclusion in TEX- study.
description: We will use validated questionnaires to estimate quality of life and to evaluate depression.
measure: Difference in activity level between groups
time frame: 5 years after inclusion i RCT, TEX study.
description: To estimate activity the study population will fill out a validated questionnaire about physical activity, and they will wear a physical activity monitor at home for one week.
arm group label: Intervention group
description: Group that followed high- intensity interval training program in TEX study.
arm group label: Control group
description: Followed up on a regular basis for HTx recipients in Norway.
Blodsamples from the patients will be studied:

      Standard samples: RBC, WBC, plates, CRP, kreatinin, urea, liver tests, thyorid gland tests,
      lipid profile, fasting- glucose og hba1c, Pro BNP, troponin T, uric acid.

      Supplement: Inflammation cytokines/chemokines such as TNF alfa, sTNFR2 og IL-6, IL-10, MCP-1
      og IL-8. Growth factors and inhibitors for innervation. Markers for endothelial function;
      endotelin and von- Willebrand faktor and anti- trombotic factors; fibrinogen, plasminogen
      activator inhibitor-1.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lars Gullestad, professor
role: Study Director
affiliation: OUS- kardiologisk avdeling
facility: 
country: Norway
citation: Nytroen K, Myers J, Chan KN, Geiran OR, Gullestad L. Chronotropic responses to exercise in heart transplant recipients: 1-yr follow-up. Am J Phys Med Rehabil. 2011 Jul;90(7):579-88. doi: 10.1097/PHM.0b013e31821f711d.
PMID: 21765276
citation: Nytroen K, Rustad LA, Gude E, Hallen J, Fiane AE, Rolid K, Holm I, Aakhus S, Gullestad L. Muscular exercise capacity and body fat predict VO(2peak) in heart transplant recipients. Eur J Prev Cardiol. 2014 Jan;21(1):21-9. doi: 10.1177/2047487312450540. Epub 2012 Jun 1.
PMID: 22659939
citation: Nytroen K, Rustad LA, Erikstad I, Aukrust P, Ueland T, Lekva T, Gude E, Wilhelmsen N, Hervold A, Aakhus S, Gullestad L, Arora S. Effect of high-intensity interval training on progression of cardiac allograft vasculopathy. J Heart Lung Transplant. 2013 Nov;32(11):1073-80. doi: 10.1016/j.healun.2013.06.023. Epub 2013 Jul 29.
PMID: 23906899
citation: Nytroen K, Rustad LA, Aukrust P, Ueland T, Hallen J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Transplant. 2012 Nov;12(11):3134-42. doi: 10.1111/j.1600-6143.2012.04221.x. Epub 2012 Aug 17.
PMID: 22900793
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Marianne Yardley
investigator title: Cand med