<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/NCT01671566</url>
  </required_header>
  <id_info>
    <org_study_id>GUCHUmU01</org_study_id>
    <nct_id>NCT01671566</nct_id>
  </id_info>
  <brief_title>Interval Training in Adults With Congenital Heart Disease a Randomized Trial</brief_title>
  <official_title>Effect of Home Based Interval Training on Exercise Capacity and Quality of Life in Adults With Congenital Heart Disease - a Randomized Controlled Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umeå University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umeå University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adults with congenital heart disease have various degrees of impaired exercise capacity&#xD;
      compared to healthy controls. Impaired exercise capacity makes everyday activities more&#xD;
      difficult and demanding. There are few studies on effect of exercise training in adults with&#xD;
      congenital heart disease. The hypothesis of this study is that structured home based exercise&#xD;
      training will improve exercise capacity and health status in the studied population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number adults with congenital heart disease is increasing. Thanks to advances in the&#xD;
      medical and surgical fields the number of adults with complex congenital heart disease is now&#xD;
      higher than the children with corresponding heart disease. Though the long term prognosis is&#xD;
      still unknown and continuously changing as new therapeutic options are introduced.&#xD;
&#xD;
      Persons with congenital heart disease have different degrees of impaired exercise capacity&#xD;
      compared to healthy controls. Some studies indicate that this population is not sufficiently&#xD;
      active to achieve the recommendations for physical activity in preventing acquired heart&#xD;
      disease. Physical inactivity is an important risk factor for developing acquired heart&#xD;
      disease and other life style diseases as obesity and diabetes. In a population where one or&#xD;
      more previous cardiac surgeries are common, the prevention of life style diseases is&#xD;
      especially important. Exercise training in heart failure and coronary artery disease is well&#xD;
      studied and there are clinical guidelines. Regarding exercise training in adults with&#xD;
      congenital heart disease, however,the information is sparse and further studies are needed.&#xD;
&#xD;
      Based on defined inclusion and exclusion criteria adults with complex congenital heart&#xD;
      disease will be recruited in the Northern Health Care Region in Sweden and in Gothenburg.&#xD;
      Before and after the twelve week intervention period the investigators will collect&#xD;
      information about cardiopulmonary exercise capacity, health related quality of life, exercise&#xD;
      self-efficacy, anxiety and depression. The patients will be randomized to twelve weeks of&#xD;
      home based interval training or to a control group. The randomization ratio will be 2:1&#xD;
      (intervention:control). The control group will be instructed to continue with their habitual&#xD;
      physical activities. The home based interval training program will be individualized based on&#xD;
      the results of the exercise tests.&#xD;
&#xD;
      The aim of this study is to examine the effect of home based interval training on maximal and&#xD;
      submaximal exercise capacity, quality of life, exercise self-efficacy, anxiety and&#xD;
      depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak VO2 (ml/kg/min)</measure>
    <time_frame>Before homebased interval exrecise regime and after completion (12 weeks)</time_frame>
    <description>Comparison within and between groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endurance time</measure>
    <time_frame>Before homebased interval exercise regimen and at completion (12 weeks)</time_frame>
    <description>at CPET-incremental and constant work rate test at 75% of peak work rate (Watt). Comparison between and within groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).</measure>
    <time_frame>Before homebased interval exercise regime and at completion (12 weeks)</time_frame>
    <description>(Peak VO2 (l/min) and Iso time, VCO2, VE/VCO2, VE/VCO2-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart Rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Once a week during homebased exercise regime</time_frame>
    <description>Complications to training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Before homebased interval exercise regime and at completion (12 weeks)</time_frame>
    <description>The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison between and within groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>Before homebased interval exercise regime and after completion (12 weeks)</time_frame>
    <description>The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise self-efficacy</measure>
    <time_frame>Before homebased interval exercise regime and after completion</time_frame>
    <description>The Exercise Self-Efficacy Scale will be used. Comparison within and between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>Before homebased interval exercise regime and after completion (12 weeks)</time_frame>
    <description>The hospital anxiety and depression scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison between and within groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response during CPET incremental and constant work rate test at 75 % of peak work rate (Watt).</measure>
    <time_frame>12 months after completion</time_frame>
    <description>( Peak VO2 and Iso time(l/min), VCO2, VE/VCO2, VE/VCO-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak VO2( ml/kg/min)</measure>
    <time_frame>12 months after completion</time_frame>
    <description>Comparison within and between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endurance time</measure>
    <time_frame>12 months after completion</time_frame>
    <description>at CPET incremental and constant work rate at 75% of peak work rate (Watt)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>12 months after completion</time_frame>
    <description>The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison within and between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity level</measure>
    <time_frame>12 months after completion</time_frame>
    <description>The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>12 months after completion</time_frame>
    <description>The hospital Anxiety and Depression Scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison within and between groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Congenital Heart Defects</condition>
  <arm_group>
    <arm_group_label>Home based interval training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks home based interval training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No structured exercise training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home based interval training</intervention_name>
    <description>The participant in the intervention group will receive an individualized interval training program. The individualized adjustments in training load will be made from the results of the CPET-incremental and adjustments in training time from the results of the constant work rate 75% of peak work rate (Watt). The training will be home based and performed on a ergometer cycle 3 times a week for twelve weeks. During exercise they will wear a heart rate monitoring watch. The registered heart rate will be transferred to a webpage after the exercise session. Only the physiotherapist and participant have the access to this page. The physiotherapist and participant will have a weekly contact to promote compliance, provide feedback and if necessary adjust the training time or load. Progression in training load and time will be made when necessary to keep a relevant intensity.</description>
    <arm_group_label>Home based interval training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Complex congenital heart disease (e.g.; Tetralogy of Fallot, Transpositions of the&#xD;
             great arteries, Ebstein, Eisenmenger, Pulmonary atresia or Tricuspid atresia)&#xD;
&#xD;
          -  Clinically stable without significant change the last 3 months&#xD;
&#xD;
          -  Adult (&gt;18 years)&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Signs of arrhythmia on exercise ECG or relevant clinical arrhythmia&#xD;
&#xD;
          -  Mental retardation or psychiatric illness affecting the ability of independent&#xD;
             decisions&#xD;
&#xD;
          -  Other comorbidity affecting physical activity&#xD;
&#xD;
          -  Other circumstances making participation unsuitable&#xD;
&#xD;
          -  Present strategy of regularly executing physical exercise &gt; 2 times/week in purpose to&#xD;
             increase cardiovascular capacity.&#xD;
&#xD;
          -  VO2 peak &gt; 30 ml/kg/min&#xD;
&#xD;
          -  No access to internet&#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>Bengt Johansson, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Umea University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sahlgrenska University hospital</name>
      <address>
        <city>Gothenburg</city>
        <zip>SE- 413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Umeå</city>
        <zip>90185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>March 3, 2016</last_update_submitted>
  <last_update_submitted_qc>March 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umeå University</investigator_affiliation>
    <investigator_full_name>Bengt Johansson</investigator_full_name>
    <investigator_title>MD,PhD</investigator_title>
  </responsible_party>
  <keyword>Congenital Heart defect</keyword>
  <keyword>Exercise and Physical fitness</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Behaviour</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT01671566
org study id: GUCHUmU01
nct id: NCT01671566
lead sponsor: 
has dmc: No
Adults with congenital heart disease have various degrees of impaired exercise capacity
      compared to healthy controls. Impaired exercise capacity makes everyday activities more
      difficult and demanding. There are few studies on effect of exercise training in adults with
      congenital heart disease. The hypothesis of this study is that structured home based exercise
      training will improve exercise capacity and health status in the studied population.
The number adults with congenital heart disease is increasing. Thanks to advances in the
      medical and surgical fields the number of adults with complex congenital heart disease is now
      higher than the children with corresponding heart disease. Though the long term prognosis is
      still unknown and continuously changing as new therapeutic options are introduced.

      Persons with congenital heart disease have different degrees of impaired exercise capacity
      compared to healthy controls. Some studies indicate that this population is not sufficiently
      active to achieve the recommendations for physical activity in preventing acquired heart
      disease. Physical inactivity is an important risk factor for developing acquired heart
      disease and other life style diseases as obesity and diabetes. In a population where one or
      more previous cardiac surgeries are common, the prevention of life style diseases is
      especially important. Exercise training in heart failure and coronary artery disease is well
      studied and there are clinical guidelines. Regarding exercise training in adults with
      congenital heart disease, however,the information is sparse and further studies are needed.

      Based on defined inclusion and exclusion criteria adults with complex congenital heart
      disease will be recruited in the Northern Health Care Region in Sweden and in Gothenburg.
      Before and after the twelve week intervention period the investigators will collect
      information about cardiopulmonary exercise capacity, health related quality of life, exercise
      self-efficacy, anxiety and depression. The patients will be randomized to twelve weeks of
      home based interval training or to a control group. The randomization ratio will be 2:1
      (intervention:control). The control group will be instructed to continue with their habitual
      physical activities. The home based interval training program will be individualized based on
      the results of the exercise tests.

      The aim of this study is to examine the effect of home based interval training on maximal and
      submaximal exercise capacity, quality of life, exercise self-efficacy, anxiety and
      depression.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Peak VO2 (ml/kg/min)
time frame: Before homebased interval exrecise regime and after completion (12 weeks)
description: Comparison within and between groups
measure: Endurance time
time frame: Before homebased interval exercise regimen and at completion (12 weeks)
description: at CPET-incremental and constant work rate test at 75% of peak work rate (Watt). Comparison between and within groups.
measure: Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).
time frame: Before homebased interval exercise regime and at completion (12 weeks)
description: (Peak VO2 (l/min) and Iso time, VCO2, VE/VCO2, VE/VCO2-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart Rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.
measure: Adverse events
time frame: Once a week during homebased exercise regime
description: Complications to training
measure: Quality of life
time frame: Before homebased interval exercise regime and at completion (12 weeks)
description: The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison between and within groups.
measure: Physical activity level
time frame: Before homebased interval exercise regime and after completion (12 weeks)
description: The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.
measure: Exercise self-efficacy
time frame: Before homebased interval exercise regime and after completion
description: The Exercise Self-Efficacy Scale will be used. Comparison within and between groups
measure: Anxiety and depression
time frame: Before homebased interval exercise regime and after completion (12 weeks)
description: The hospital anxiety and depression scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison between and within groups.
measure: Response during CPET incremental and constant work rate test at 75 % of peak work rate (Watt).
time frame: 12 months after completion
description: ( Peak VO2 and Iso time(l/min), VCO2, VE/VCO2, VE/VCO-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.
measure: Peak VO2( ml/kg/min)
time frame: 12 months after completion
description: Comparison within and between groups
measure: Endurance time
time frame: 12 months after completion
description: at CPET incremental and constant work rate at 75% of peak work rate (Watt)
measure: Quality of life
time frame: 12 months after completion
description: The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison within and between groups.
measure: Physical Activity level
time frame: 12 months after completion
description: The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.
measure: Anxiety and depression
time frame: 12 months after completion
description: The hospital Anxiety and Depression Scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison within and between groups.
arm group label: Home based interval training
arm group type: Experimental
description: 12 weeks home based interval training
arm group label: Control group
arm group type: No Intervention
description: No structured exercise training.
intervention type: Behavioral
intervention name: Home based interval training
description: The participant in the intervention group will receive an individualized interval training program. The individualized adjustments in training load will be made from the results of the CPET-incremental and adjustments in training time from the results of the constant work rate 75% of peak work rate (Watt). The training will be home based and performed on a ergometer cycle 3 times a week for twelve weeks. During exercise they will wear a heart rate monitoring watch. The registered heart rate will be transferred to a webpage after the exercise session. Only the physiotherapist and participant have the access to this page. The physiotherapist and participant will have a weekly contact to promote compliance, provide feedback and if necessary adjust the training time or load. Progression in training load and time will be made when necessary to keep a relevant intensity.
arm group label: Home based interval training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bengt Johansson, MD, Phd
role: Principal Investigator
affiliation: Umea University
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Umeå University
investigator full name: Bengt Johansson
investigator title: MD,PhD
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital