<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/NCT02240147</url>
  </required_header>
  <id_info>
    <org_study_id>S2S-ACHD</org_study_id>
    <nct_id>NCT02240147</nct_id>
  </id_info>
  <brief_title>Start-to-Sport - Home-based Exercise for Adolescents and Adults With Congenital Heart Disease</brief_title>
  <acronym>S2S-ACHD</acronym>
  <official_title>Start-to-Sport - Feasibility and Efficacy of Individualized, Telemonitored, Home-based Exercise for Adolescents and Adults With Congenital Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even&#xD;
      though outcomes are good, they need lifelong follow-up because of a higher risk for&#xD;
      cardiovascular diseases. Studies have shown that patients with CHD are not active enough and&#xD;
      that a substantial amount of patients is overweight. Hence preventive strategies and&#xD;
      education should not only focus on the heart problem, but also on a healthy lifestyle&#xD;
      including physical activity. Recently a new guideline introduced exercise prescription based&#xD;
      on the absence/presence of certain key elements. However, a number of important questions&#xD;
      remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport'&#xD;
      program for adults with CHD, based on this new guideline, will be investigated. This study is&#xD;
      a randomized controlled trial that investigates the effects of the program on daily physical&#xD;
      activity, exercise capacity, quality of life and exercise self-efficacy both in short (12&#xD;
      weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by&#xD;
      using a new exercise-testing protocol that looks simultaneously to all body parts that are&#xD;
      involved during exercise. Ultimately, our findings will result in the implementation of the&#xD;
      guideline in clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>peak oxygen uptake</measure>
    <time_frame>baseline, post-intervention, after 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>physical activity</measure>
    <time_frame>baseline, post-intervention and after 1 year</time_frame>
    <description>Physical activity will be assessed by means of the Sensewear mini armband. The patient will be asked to wear the device day and night during 1 week, while also taking notes of the physical activities undertaken by means of a logbook.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Congenital Heart Defect</condition>
  <arm_group>
    <arm_group_label>home-based exercise training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>home-based exercise training</intervention_name>
    <description>During a 30 minute face-to-face motivational interview with an exercise specialist, the patient will be advised and coached about his exercise prescription, on how to implement it in his own daily life and on how to prevent relapse. Furthermore, the patients will receive instructions on how to monitor their exercise intensity and on recognizing adverse signals. During the following 12 weeks, patients will be asked to exercise 4.5 hours per week within the prescribed exercise intensity range according to the guidelines.</description>
    <arm_group_label>home-based exercise training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adolescents and adults with congenital heart disease&#xD;
&#xD;
          -  16 to 65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital rhythm or conduction disorders&#xD;
&#xD;
          -  isolated congenital coronary artery anomalies&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  being listed for heart transplantation&#xD;
&#xD;
          -  inability to perform standard physical activities due to mental/physical disability.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roselien Buys, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Werner Budts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Budts W, Borjesson M, Chessa M, van Buuren F, Trigo Trindade P, Corrado D, Heidbuchel H, Webb G, Holm J, Papadakis M. Physical activity in adolescents and adults with congenital heart defects: individualized exercise prescription. Eur Heart J. 2013 Dec;34(47):3669-74. doi: 10.1093/eurheartj/eht433. Epub 2013 Nov 7. No abstract available.</citation>
    <PMID>24204010</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Roselien Buys</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>adult congenital heart disease</keyword>
  <keyword>exercise capacity</keyword>
  <keyword>exercise training</keyword>
  <keyword>physical activity</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/NCT02240147
org study id: S2S-ACHD
nct id: NCT02240147
lead sponsor: 
has dmc: No
Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even
      though outcomes are good, they need lifelong follow-up because of a higher risk for
      cardiovascular diseases. Studies have shown that patients with CHD are not active enough and
      that a substantial amount of patients is overweight. Hence preventive strategies and
      education should not only focus on the heart problem, but also on a healthy lifestyle
      including physical activity. Recently a new guideline introduced exercise prescription based
      on the absence/presence of certain key elements. However, a number of important questions
      remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport'
      program for adults with CHD, based on this new guideline, will be investigated. This study is
      a randomized controlled trial that investigates the effects of the program on daily physical
      activity, exercise capacity, quality of life and exercise self-efficacy both in short (12
      weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by
      using a new exercise-testing protocol that looks simultaneously to all body parts that are
      involved during exercise. Ultimately, our findings will result in the implementation of the
      guideline in clinical practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: peak oxygen uptake
time frame: baseline, post-intervention, after 1 year
measure: physical activity
time frame: baseline, post-intervention and after 1 year
description: Physical activity will be assessed by means of the Sensewear mini armband. The patient will be asked to wear the device day and night during 1 week, while also taking notes of the physical activities undertaken by means of a logbook.
arm group label: home-based exercise training
arm group type: Experimental
arm group label: Control group
arm group type: No Intervention
intervention type: Behavioral
intervention name: home-based exercise training
description: During a 30 minute face-to-face motivational interview with an exercise specialist, the patient will be advised and coached about his exercise prescription, on how to implement it in his own daily life and on how to prevent relapse. Furthermore, the patients will receive instructions on how to monitor their exercise intensity and on recognizing adverse signals. During the following 12 weeks, patients will be asked to exercise 4.5 hours per week within the prescribed exercise intensity range according to the guidelines.
arm group label: home-based exercise training
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Roselien Buys, PhD
role: Principal Investigator
affiliation: KU Leuven
last name: Werner Budts, PhD
role: Principal Investigator
affiliation: KU Leuven
facility: 
country: Belgium
citation: Budts W, Borjesson M, Chessa M, van Buuren F, Trigo Trindade P, Corrado D, Heidbuchel H, Webb G, Holm J, Papadakis M. Physical activity in adolescents and adults with congenital heart defects: individualized exercise prescription. Eur Heart J. 2013 Dec;34(47):3669-74. doi: 10.1093/eurheartj/eht433. Epub 2013 Nov 7. No abstract available.
PMID: 24204010
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Roselien Buys
investigator title: Dr.
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital