xml: <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/NCT05964322</url>
    </required_header>
    <id_info>
      <org_study_id>RECHMPL23_0225</org_study_id>
      <nct_id>NCT05964322</nct_id>
    </id_info>
    <brief_title>Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome</brief_title>
    <acronym>RYTHMO'FIT</acronym>
    <official_title>Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Montpellier</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Montpellier</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Children and adolescents with inherited cardiac arrhythmia su ch Long QT Syndrome (LQTS) have&#xD;
        lower physical and quality of life than their healthy peers. A multi-component cardiac&#xD;
        rehabilitation, including an exercise training program and education program, might&#xD;
        counteract those effects.&#xD;
  &#xD;
        The goal of this pilot study is to evaluate the security, feasibility, and benefits of a&#xD;
        cardiac rehabilitation program in children with LQTS aged between 6 to 18 years old.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Is center-based cardiac rehabilitation safe and feasible for children with LQTS?&#xD;
  &#xD;
          -  Does a 12-week cardiac rehabilitation program improve physical fitness and quality of&#xD;
             life?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Physical fitness is an independent predictor of all-cause mortality and global health in the&#xD;
        general population. Assessments of cardiorespiratory and muscle fitness in children with&#xD;
        chronic illness are growing in interest, even in less prevalent chronic diseases. For&#xD;
        instance, children and adolescents with Long QT Syndrome (LQTS) have lower cardiorespiratory&#xD;
        fitness, muscle strength, and quality of life than their healthy peers.&#xD;
  &#xD;
        A multi-component cardiac rehabilitation including an exercise training program and education&#xD;
        program might counteract this lowered physical fitness.&#xD;
  &#xD;
        The RYTHMO'FIT pilot study seeks to test the security, and feasibility, and to evaluate the&#xD;
        benefits of an innovative center-based program to improve physical and mental health in&#xD;
        children and adolescents with LQTS.&#xD;
  &#xD;
        In this retrospective study, eight children had undergone a 12-week program, within each&#xD;
        session composed by:&#xD;
  &#xD;
          -  A 1-hour exercise training session with a trained exercise physiologist: resistance&#xD;
             training, aerobic training, stretching, and different activity (e.g., basketball,&#xD;
             handball, football, hockey)&#xD;
  &#xD;
          -  A 30-min educational workshop with a specialist nurse (e.g., beta-blockade, sports&#xD;
             participation, healthy behaviors).&#xD;
  &#xD;
          -  A 10-min medical interview with a cardiologist to have feedback from parents and&#xD;
             patients on each session and the past 7 seven days.&#xD;
  &#xD;
        We hypothesized the RYTHMO'FIT study is safe, feasible, and provides benefits for mental and&#xD;
        physical health in children and adolescents with LQTS. If the results of this pilot study are&#xD;
        positive, they will lead to a larger randomized multicentric controlled trial to evaluate the&#xD;
        effectiveness of a hybrid cardiac rehabilitation program in children, adolescents, and young&#xD;
        adults with LQTS.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">February 2, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Actual">March 7, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Security</measure>
      <time_frame>At week 12</time_frame>
      <description>Count and specify any cardiac events on the ECG scope during each session. Reporting of related and non-related event during the past 7 days through short questionnaire each week.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recruitment rates</measure>
      <time_frame>At week 12</time_frame>
      <description>Number of participants who completed baseline assessment compared to the number who were eligible (expressed in %).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention rates</measure>
      <time_frame>At week 12</time_frame>
      <description>Participants who participated in the 12-week intervention and completed the follow-up assessments at the end of the program (expressed in %).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence</measure>
      <time_frame>At week 12</time_frame>
      <description>Percentage exercise sessions attained by participants compared to number of sessions proposed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change on cardiorespiratory fitness</measure>
      <time_frame>between week 0 and week 12</time_frame>
      <description>Assessing the following variables by cardiopulmonary exercise testing: peak oxygen uptake (VO2peak), ventilatory anaerobic threshold (VAT), ventilatory efficiency (VE/VCO2 slope), maximum heart rate (HR), oxygen pulse (VO2/HR), maximal power, respiratory exchange ratio.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on muscle architecture</measure>
      <time_frame>between week 0 and week 12</time_frame>
      <description>Assessing the following variables by ultrasounding: Anatomical cross sectional area, pennation angle, fascicle length and muscle thickness</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on muscle strength</measure>
      <time_frame>between week 0 and week 12</time_frame>
      <description>Lower and upper limb maximal isometric strength by knee extension and handgrip test, respectively. Lower body explosive muscular strength was assessed by standing long broad jump.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on physical activity level</measure>
      <time_frame>between week 0 and week 12</time_frame>
      <description>Time spent in vigorous, moderate-to-vigorous, light physical activity assessed by waist-worn tri axial accelerometer during 7 days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on Self reported total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire</measure>
      <time_frame>between week 0 and week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL)</measure>
      <time_frame>between week 0 and week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Quality of Life Inventory (PedsQL) 4.0 Health-related quality (HRQoL ) of life questionnaire score per dimension (self and proxy reports)</measure>
      <time_frame>between week 0 and week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on cardiological outcomes</measure>
      <time_frame>between week 0 and week 12</time_frame>
      <description>Electrocardiographic at rest (QTc, heart rate, PR, QRS interval time) and echocardiography (LVEF, IVSd, IVSs, LVEDV, E/A ratio)</description>
    </secondary_outcome>
    <enrollment type="Actual">8</enrollment>
    <condition>Long QT Syndrome</condition>
    <condition>Congenital Long Qt Syndrome</condition>
    <condition>Inherited Cardiac Conduction Disorder</condition>
    <condition>Pediatric ALL</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Children aged 8 to 18 years with an LQTS.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          -  Children and adolescents, aged 6 to 18 years old, diagnosed with congenital LQTS and&#xD;
               had been recently under medical check-up in our last study QUALIMYORYTHM&#xD;
  &#xD;
            -  With impaired cardiorespiratory fitness (VO2 peak &lt;80% of predicted values or VAT &lt;55%&#xD;
               of predicted values) or with normal cardiorespiratory fitness but requiring patient&#xD;
               education and information on limits/security in taking part in sports participation.&#xD;
  &#xD;
            -  Willingness and ability for parents and children to take part in a 12-week&#xD;
               center-based program (e.g., availability during the school period, transportation&#xD;
               options)&#xD;
  &#xD;
            -  Informed consent of parents or legal guardians, and oral assent of children.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pascal AMEDRO, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Bordeaux - Haut-Levêque Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University Hospital of Montpellier - Arnaud de Villeneuve Hospita</name>
        <address>
          <city>Montpellier</city>
          <zip>34295</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Saint-Pierre Institute</name>
        <address>
          <city>Palavas-les-Flots</city>
          <zip>34250</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <reference>
      <citation>Souilla L, Avesani M, Boisson A, Requirand A, Matecki S, Vincenti M, Werner O, De La Villeon G, Pommier V, Pasquie JL, Guillaumont S, Amedro P. Cardiorespiratory fitness, muscle fitness, and physical activity in children with long QT syndrome: A prospective controlled study. Front Cardiovasc Med. 2023 Jan 11;9:1081106. doi: 10.3389/fcvm.2022.1081106. eCollection 2022.</citation>
      <PMID>36712265</PMID>
    </reference>
    <reference>
      <citation>Amedro P, Werner O, Abassi H, Boisson A, Souilla L, Guillaumont S, Calderon J, Requirand A, Vincenti M, Pommier V, Matecki S, De La Villeon G, Lavastre K, Lacampagne A, Picot MC, Beyler C, Delclaux C, Dulac Y, Guitarte A, Charron P, Denjoy-Urbain I, Probst V, Baruteau AE, Chevalier P, Di Filippo S, Thambo JB, Bonnet D, Pasquie JL. Health-related quality of life and physical activity in children with inherited cardiac arrhythmia or inherited cardiomyopathy: the prospective multicentre controlled QUALIMYORYTHM study rationale, design and methods. Health Qual Life Outcomes. 2021 Jul 28;19(1):187. doi: 10.1186/s12955-021-01825-6.</citation>
      <PMID>34321045</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cardiac Rehabilitation</keyword>
    <keyword>Long QT syndrome</keyword>
    <keyword>Pediatric</keyword>
    <keyword>Exercise training</keyword>
    <keyword>Educational program</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Long QT Syndrome</mesh_term>
      <mesh_term>Cardiac Conduction System Disease</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964322
  org study id: RECHMPL23_0225
  nct id: NCT05964322
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Children and adolescents with inherited cardiac arrhythmia su ch Long QT Syndrome (LQTS) have
        lower physical and quality of life than their healthy peers. A multi-component cardiac
        rehabilitation, including an exercise training program and education program, might
        counteract those effects.
  
        The goal of this pilot study is to evaluate the security, feasibility, and benefits of a
        cardiac rehabilitation program in children with LQTS aged between 6 to 18 years old.
  
        The main question[s] it aims to answer are:
  
          -  Is center-based cardiac rehabilitation safe and feasible for children with LQTS?
  
          -  Does a 12-week cardiac rehabilitation program improve physical fitness and quality of
             life?
  Physical fitness is an independent predictor of all-cause mortality and global health in the
        general population. Assessments of cardiorespiratory and muscle fitness in children with
        chronic illness are growing in interest, even in less prevalent chronic diseases. For
        instance, children and adolescents with Long QT Syndrome (LQTS) have lower cardiorespiratory
        fitness, muscle strength, and quality of life than their healthy peers.
  
        A multi-component cardiac rehabilitation including an exercise training program and education
        program might counteract this lowered physical fitness.
  
        The RYTHMO'FIT pilot study seeks to test the security, and feasibility, and to evaluate the
        benefits of an innovative center-based program to improve physical and mental health in
        children and adolescents with LQTS.
  
        In this retrospective study, eight children had undergone a 12-week program, within each
        session composed by:
  
          -  A 1-hour exercise training session with a trained exercise physiologist: resistance
             training, aerobic training, stretching, and different activity (e.g., basketball,
             handball, football, hockey)
  
          -  A 30-min educational workshop with a specialist nurse (e.g., beta-blockade, sports
             participation, healthy behaviors).
  
          -  A 10-min medical interview with a cardiologist to have feedback from parents and
             patients on each session and the past 7 seven days.
  
        We hypothesized the RYTHMO'FIT study is safe, feasible, and provides benefits for mental and
        physical health in children and adolescents with LQTS. If the results of this pilot study are
        positive, they will lead to a larger randomized multicentric controlled trial to evaluate the
        effectiveness of a hybrid cardiac rehabilitation program in children, adolescents, and young
        adults with LQTS.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Security
  time frame: At week 12
  description: Count and specify any cardiac events on the ECG scope during each session. Reporting of related and non-related event during the past 7 days through short questionnaire each week.
  measure: Recruitment rates
  time frame: At week 12
  description: Number of participants who completed baseline assessment compared to the number who were eligible (expressed in %).
  measure: Retention rates
  time frame: At week 12
  description: Participants who participated in the 12-week intervention and completed the follow-up assessments at the end of the program (expressed in %).
  measure: Adherence
  time frame: At week 12
  description: Percentage exercise sessions attained by participants compared to number of sessions proposed.
  measure: Change on cardiorespiratory fitness
  time frame: between week 0 and week 12
  description: Assessing the following variables by cardiopulmonary exercise testing: peak oxygen uptake (VO2peak), ventilatory anaerobic threshold (VAT), ventilatory efficiency (VE/VCO2 slope), maximum heart rate (HR), oxygen pulse (VO2/HR), maximal power, respiratory exchange ratio.
  measure: Change on muscle architecture
  time frame: between week 0 and week 12
  description: Assessing the following variables by ultrasounding: Anatomical cross sectional area, pennation angle, fascicle length and muscle thickness
  measure: Change on muscle strength
  time frame: between week 0 and week 12
  description: Lower and upper limb maximal isometric strength by knee extension and handgrip test, respectively. Lower body explosive muscular strength was assessed by standing long broad jump.
  measure: Change on physical activity level
  time frame: between week 0 and week 12
  description: Time spent in vigorous, moderate-to-vigorous, light physical activity assessed by waist-worn tri axial accelerometer during 7 days.
  measure: Change on Self reported total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire
  time frame: between week 0 and week 12
  measure: Change on Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL)
  time frame: between week 0 and week 12
  measure: Pediatric Quality of Life Inventory (PedsQL) 4.0 Health-related quality (HRQoL ) of life questionnaire score per dimension (self and proxy reports)
  time frame: between week 0 and week 12
  measure: Change on cardiological outcomes
  time frame: between week 0 and week 12
  description: Electrocardiographic at rest (QTc, heart rate, PR, QRS interval time) and echocardiography (LVEF, IVSd, IVSs, LVEDV, E/A ratio)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Pascal AMEDRO, Professor
  role: Principal Investigator
  affiliation: University Hospital of Bordeaux - Haut-Levêque Hospital
  facility: 
  facility: 
  country: France
  citation: Souilla L, Avesani M, Boisson A, Requirand A, Matecki S, Vincenti M, Werner O, De La Villeon G, Pommier V, Pasquie JL, Guillaumont S, Amedro P. Cardiorespiratory fitness, muscle fitness, and physical activity in children with long QT syndrome: A prospective controlled study. Front Cardiovasc Med. 2023 Jan 11;9:1081106. doi: 10.3389/fcvm.2022.1081106. eCollection 2022.
  PMID: 36712265
  citation: Amedro P, Werner O, Abassi H, Boisson A, Souilla L, Guillaumont S, Calderon J, Requirand A, Vincenti M, Pommier V, Matecki S, De La Villeon G, Lavastre K, Lacampagne A, Picot MC, Beyler C, Delclaux C, Dulac Y, Guitarte A, Charron P, Denjoy-Urbain I, Probst V, Baruteau AE, Chevalier P, Di Filippo S, Thambo JB, Bonnet D, Pasquie JL. Health-related quality of life and physical activity in children with inherited cardiac arrhythmia or inherited cardiomyopathy: the prospective multicentre controlled QUALIMYORYTHM study rationale, design and methods. Health Qual Life Outcomes. 2021 Jul 28;19(1):187. doi: 10.1186/s12955-021-01825-6.
  PMID: 34321045
  responsible party type: Sponsor
  mesh term: Long QT Syndrome
  mesh term: Cardiac Conduction System Disease
  mesh term: Syndrome