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/NCT06015191</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00000990</org_study_id>
      <nct_id>NCT06015191</nct_id>
    </id_info>
    <brief_title>Remote Cardiac Rehab for Adolescents With Congenital Heart Disease</brief_title>
    <acronym>Remote-CaRe</acronym>
    <official_title>Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Mercy Hospital Kansas City</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Kansas</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Children's Hospital of Philadelphia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Children's Mercy Hospital Kansas City</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this randomized controlled trial is to evaluate the effectiveness of video&#xD;
        conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR)&#xD;
        exercise training to groups of adolescents with congenital heart disease (CHD) in their&#xD;
        homes. Participants will be randomized to either the remote cardiac rehab (RCR) group or&#xD;
        active control group. The RCR group will participate in live, group-based exercise training&#xD;
        (3-5 participants per exercise session), in their homes 3 days per week for 45 minutes over&#xD;
        12-weeks. Exercise sessions will be led and supervised by a live health coach via telehealth&#xD;
        video technology. The active control group will be provided informational handouts on health&#xD;
        exercise for their cardiac diagnosis. The primary aim is to compare between group changes&#xD;
        (0-12-weeks) in cardiorespiratory fitness (VO2peak). Secondary aims are to compare between&#xD;
        group changes (0-12-weeks) in cardiac function (echocardiography), lean body mass, and&#xD;
        physical frailty. Exploratory aims will compare between group changes (0-12-weeks) in&#xD;
        physical function, quality of life, skeletal muscle function, and physical activity&#xD;
        self-efficacy. Additionally, exploratory aims will explore the impact of demographic&#xD;
        characteristics, program participation, program satisfaction, and daily physical activity on&#xD;
        changes in cardiorespiratory fitness.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This randomized controlled trial will evaluate the effectiveness of live, in-home,&#xD;
        group-based cardiac rehabilitation (CR) exercise training compared to standard care (active)&#xD;
        control. Participants will include adolescents (age 12-19 years) with one of three congenital&#xD;
        heart disease (CHD) diagnoses: Fontan (single ventricle) circulation, Tetralogy of Fallot, or&#xD;
        dextro-transposition of the great vessels. Following baseline outcomes testing, participants&#xD;
        will be computer randomized (with equal stratification by CHD diagnosis and biologic sex) to&#xD;
        either the remote cardiac rehab (RCR) group (n=~37) or the active control group (n=~37).&#xD;
        Participants randomized to the RCR group will participate in 12-weeks of live-supervised&#xD;
        exercise training (36 sessions total) from their respective homes led by a trained health&#xD;
        coach via telehealth video technology. RCR participants will initially engage in a 2-week&#xD;
        ramp-up period (1-1 or small groups, 6-sessions total) with a live health coach, followed by&#xD;
        10-weeks of group-based (3-5 participants, 30 sessions total) exercise training where&#xD;
        participants will be able to interact with the health coach and other participants.&#xD;
        Participants in the RCR group will be asked to attend and participate in exercise sessions 3&#xD;
        days per week for 45-minutes. Exercise session intensity will be consistent with a heart rate&#xD;
        of 60-75% of their VO2peak, will consist of a mix of flexibility, aerobic, and anaerobic&#xD;
        exercise, and will be facilitated by a small set of exercise equipment (e.g., resistance&#xD;
        bands, cones, medicine balls) provided to participants. Participants randomized to the active&#xD;
        control group will be provided handouts that describe exercises consistent with the physical&#xD;
        activity recommendations for youth. The total intervention period for both groups will be&#xD;
        12-weeks. Primary, secondary, and exploratory outcomes will be measured at baseline and&#xD;
        12-13-weeks following randomization. Additionally, participants in both groups will be&#xD;
        provided a consumer grade wrist-worn physical activity monitor, where participants will be&#xD;
        encouraged to wear throughout the 12-week intervention period and beyond for a minimum of&#xD;
        6-months. Participants randomized to the active control group will be provided the&#xD;
        opportunity to participate in the RCR exercise training once enrollment goals are met.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 31, 2023</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">January 2027</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>
      <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Peak Cardiorespiratory Fitness</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Cardiorespiratory fitness will be assessed using a peak cardiopulmonary exercise stress test (VO2peak) on a cycle ergometer using a ramping cycle protocol.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Echocardiogram with global longitudinal strain (Fontan)</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Cardiac Function for the participant with Fontan diagnosis will be assessed with echocardiogram using greyscale 2-dimensional images obtained of the single left ventricle, right ventricle or the entirety of the biventricular morphology. Global longitudinal strain analysis will be performed by averaging the apical 4, 3, or 2 images using GE EchoPAC BT13 software following American Society of Echocardiography guidelines.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Echocardiogram with global longitudinal strain (Tetralogy of Fallot and d-transposition of the great vessels)</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Cardiac Function for the participant with Tetralogy of Fallot and d-transposition of the great vessels diagnosis will be assessed with echocardiogram using greyscale 2-dimensional images obtained on the ventricles. Global longitudinal strain analysis will be performed by averaging the apical 4, 3, and 2 images using GE EchoPAC BT13 software following American Society of Echocardiography guidelines.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lean Body Mass</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Body composition will be assessed using whole-body dual energy X-ray absorptiometry (DXA)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frailty (slowness)</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Slowness will be assessed using a 6-minute walk test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frailty (weakness)</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Weakness will be assessed using handgrip strength dynamometry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frailty (fatigue)</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Fatigue will be assessed using the Pediatric quality of life inventory (PedsQL) Multidimensional Fatigue Scale (Range: 0 (high fatigue) - 100 (low fatigue))</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frailty (energy expenditure/physical activity)</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Physical activity / energy expenditure will be assessed using the self-report, past-week Physical Activity Questionnaire for Adolescents (PAQ-A) (Range: 1 (inactive) - 5 (highly active))</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Movement</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Functional Movement / gross motor proficiency will be assessed with the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (Range: -3SD (well-below average) - +4SD (well-above average)) SD = Standard deviations</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life Generic Core Scale</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Quality of life (QoL) will be assessed with the Pediatric Quality of Life inventory (PedsQL) Generic Core Scale (Range: 0 (low QoL) - 100 (high QoL))</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life Cardiac Module</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Cardiac specific quality of life (QoL) will be assessed with the Pediatric Quality of Life inventory (PedsQL) Cardiac Module (Range: 0 (low QoL) - 100 (high QoL))</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Self-Efficacy</measure>
      <time_frame>Change from baseline to 12-weeks</time_frame>
      <description>Physical activity (PA) self-efficacy will be assessed using the Domain-Specific Physical Activity Efficacy Questionnaire (mean score of 0 (low PA self-efficacy) - 100 (high PA self-efficacy)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exercise session adherence (Remote Cardiac Rehab Group)</measure>
      <time_frame>Baseline to 12-weeks</time_frame>
      <description>Exercise session adherence will be assessed using a wrist-worn Fitbit Versa 4 activity monitor. The Fitbit Versa 4 will be used to asses exercise heart rates during the exercise sessions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lifestyle Physical Activity</measure>
      <time_frame>Change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention</time_frame>
      <description>Physical activity will be assessed using a wrist-worn Fitbit Versa 4 activity monitor. The Fitbit Versa 4 will be used to determine the volume of physical activity participation in free-living conditions.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">74</enrollment>
    <condition>Congenital Heart Disease in Children</condition>
    <arm_group>
      <arm_group_label>Remote Cardiac Rehabilitation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Following a 2-week ramp-up period, participants will attend group exercise sessions, remotely delivered in their homes, 3 days per week for 45-minutes over 12-weeks led by a live-interactive health coach. There are 4 exercise session types with different modalities: Session A: 75% aerobic, 25% resistance; Session B: 25% aerobic, 75% resistance; Session C: 50% aerobic, 50% resistance; and Session D: Exercise games (mix of modalities). Each participant will rotate through a 5-week set of exercise sessions (20 sessions) twice over the 10-weeks of group exercise period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive a handout describing physical activities appropriate for their congenital heart disease diagnosis and providing recommendations consistent with the physical activity recommendations for children and adolescents.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Remote Cardiac Rehabilitation</intervention_name>
      <description>Participants will engage in a ramp-up period (weeks 0-2) where participants will attend 1-on-1 live, remote in-home exercise sessions (20-35 min./session, 3-days/wk.) delivered by a health coach via telehealth video conferencing. Participants will be provided a tablet computer and a small set of equipment. Following the ramp-up period, participants will be asked to attend live, in-home, group-based exercise sessions (weeks 3-12, 3-5 participants/group, 45-min, 3-days/wk. minimum). Sessions will be offered 4-days/wk. in the afternoons and early evenings allowing participants to select the most convenient 3 days per week to attend. Sessions will include a variety of dynamic aerobic and anaerobic (resistance) exercises with a target heart rate corresponding to 60-75% of VO2peak. In the group-based exercise sessions, participants will be able to see, hear, and verbally interact with the health coach and the other participants, allowing for supervision and encouraging social support.</description>
      <arm_group_label>Remote Cardiac Rehabilitation</arm_group_label>
      <other_name>RCR</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Active Control</intervention_name>
      <description>Participants will receive a handout describing physical activities appropriate for their congenital heart disease diagnosis and providing recommendations consistent with the physical activity recommendations for children and adolescents.</description>
      <arm_group_label>Active Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 12-19 years old&#xD;
  &#xD;
            -  Male or Female&#xD;
  &#xD;
            -  Diagnosed with one of three congenital heart diseases: Univentricular heart with&#xD;
               Fontan Palliation, Tetralogy of Fallot with transannular patch, Dextro-transposition&#xD;
               of the great arteries with arterial switch operation&#xD;
  &#xD;
            -  Clearance for exercise from their primary cardiologist&#xD;
  &#xD;
            -  Internet access in their homes&#xD;
  &#xD;
            -  Available for in-home exercise between 3-7pm on at least 3 days of the Monday-Friday&#xD;
               work week&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Physically or developmentally unable to perform outcomes assessments or participate in&#xD;
               moderate-to-vigorous intensity physical activity&#xD;
  &#xD;
            -  Participating in more than 3-months of organized athletic/exercise activity with an&#xD;
               intensity of 5.0 or more metabolic equivalents (METs) throughout the year (not&#xD;
               including school physical education)&#xD;
  &#xD;
            -  Height less than 132cm&#xD;
  &#xD;
            -  Pregnancy or planned surgery or procedure within the 12-week study period&#xD;
  &#xD;
            -  Meeting at least 1 exercise test safety or screening criteria on most recent exercise&#xD;
               test (pre-study) or baseline outcomes visit exercise test&#xD;
  &#xD;
            -  Presence of significant cardiac dysfunction that would impair safe participation in&#xD;
               moderate-to-vigorous intensity exercise&#xD;
  &#xD;
            -  Significant changes baseline echocardiogram or most recent clinical echocardiogram&#xD;
               (from past clinical echocardiogram) such as decrease in ventricular and/or valvar&#xD;
               function, new obstruction, or any new structural abnormalities&#xD;
  &#xD;
            -  Unable to meet peak exercise test criteria of respiratory exchange ratio (RER) ≥1.1&#xD;
  &#xD;
            -  Uncontrolled or poorly controlled asthma&#xD;
  &#xD;
            -  Presence of implanted cardioverter-defibrillator&#xD;
  &#xD;
            -  Significant reliance on pacemaker (atrial or ventricular pacing ≥50%)&#xD;
  &#xD;
            -  Reliance on ventricular assist device&#xD;
  &#xD;
            -  Prescribed milrinone medication&#xD;
  &#xD;
            -  Listed for heart transplantation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>19 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>David A White, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's Mercy Kansas City</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dara Watkins, MA</last_name>
      <phone>816-302-3633</phone>
      <phone_ext>73633</phone_ext>
      <email>djwatkins@cmh.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>David Cloutier, MS, MBA</last_name>
      <phone>816-302-3636</phone>
      <email>dacloutier@cmh.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Children's Mercy Kansas City</name>
        <address>
          <city>Kansas City</city>
          <state>Missouri</state>
          <zip>64108</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>David A White, PhD</last_name>
        <phone>816-731-7478</phone>
        <email>dawhite@cmh.edu</email>
      </contact>
      <contact_backup>
        <last_name>Dara Watkins, MA</last_name>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
      <investigator_full_name>David White</investigator_full_name>
      <investigator_title>Associate Professor, Exercise Physiologist</investigator_title>
    </responsible_party>
    <keyword>Exercise</keyword>
    <keyword>Cardiac Rehabilitation</keyword>
    <keyword>Physical Activity</keyword>
    <keyword>Telehealth</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06015191
  org study id: STUDY00000990
  nct id: NCT06015191
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled trial is to evaluate the effectiveness of video
        conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR)
        exercise training to groups of adolescents with congenital heart disease (CHD) in their
        homes. Participants will be randomized to either the remote cardiac rehab (RCR) group or
        active control group. The RCR group will participate in live, group-based exercise training
        (3-5 participants per exercise session), in their homes 3 days per week for 45 minutes over
        12-weeks. Exercise sessions will be led and supervised by a live health coach via telehealth
        video technology. The active control group will be provided informational handouts on health
        exercise for their cardiac diagnosis. The primary aim is to compare between group changes
        (0-12-weeks) in cardiorespiratory fitness (VO2peak). Secondary aims are to compare between
        group changes (0-12-weeks) in cardiac function (echocardiography), lean body mass, and
        physical frailty. Exploratory aims will compare between group changes (0-12-weeks) in
        physical function, quality of life, skeletal muscle function, and physical activity
        self-efficacy. Additionally, exploratory aims will explore the impact of demographic
        characteristics, program participation, program satisfaction, and daily physical activity on
        changes in cardiorespiratory fitness.
  This randomized controlled trial will evaluate the effectiveness of live, in-home,
        group-based cardiac rehabilitation (CR) exercise training compared to standard care (active)
        control. Participants will include adolescents (age 12-19 years) with one of three congenital
        heart disease (CHD) diagnoses: Fontan (single ventricle) circulation, Tetralogy of Fallot, or
        dextro-transposition of the great vessels. Following baseline outcomes testing, participants
        will be computer randomized (with equal stratification by CHD diagnosis and biologic sex) to
        either the remote cardiac rehab (RCR) group (n=~37) or the active control group (n=~37).
        Participants randomized to the RCR group will participate in 12-weeks of live-supervised
        exercise training (36 sessions total) from their respective homes led by a trained health
        coach via telehealth video technology. RCR participants will initially engage in a 2-week
        ramp-up period (1-1 or small groups, 6-sessions total) with a live health coach, followed by
        10-weeks of group-based (3-5 participants, 30 sessions total) exercise training where
        participants will be able to interact with the health coach and other participants.
        Participants in the RCR group will be asked to attend and participate in exercise sessions 3
        days per week for 45-minutes. Exercise session intensity will be consistent with a heart rate
        of 60-75% of their VO2peak, will consist of a mix of flexibility, aerobic, and anaerobic
        exercise, and will be facilitated by a small set of exercise equipment (e.g., resistance
        bands, cones, medicine balls) provided to participants. Participants randomized to the active
        control group will be provided handouts that describe exercises consistent with the physical
        activity recommendations for youth. The total intervention period for both groups will be
        12-weeks. Primary, secondary, and exploratory outcomes will be measured at baseline and
        12-13-weeks following randomization. Additionally, participants in both groups will be
        provided a consumer grade wrist-worn physical activity monitor, where participants will be
        encouraged to wear throughout the 12-week intervention period and beyond for a minimum of
        6-months. Participants randomized to the active control group will be provided the
        opportunity to participate in the RCR exercise training once enrollment goals are met.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Controlled Trial
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Peak Cardiorespiratory Fitness
  time frame: Change from baseline to 12-weeks
  description: Cardiorespiratory fitness will be assessed using a peak cardiopulmonary exercise stress test (VO2peak) on a cycle ergometer using a ramping cycle protocol.
  measure: Echocardiogram with global longitudinal strain (Fontan)
  time frame: Change from baseline to 12-weeks
  description: Cardiac Function for the participant with Fontan diagnosis will be assessed with echocardiogram using greyscale 2-dimensional images obtained of the single left ventricle, right ventricle or the entirety of the biventricular morphology. Global longitudinal strain analysis will be performed by averaging the apical 4, 3, or 2 images using GE EchoPAC BT13 software following American Society of Echocardiography guidelines.
  measure: Echocardiogram with global longitudinal strain (Tetralogy of Fallot and d-transposition of the great vessels)
  time frame: Change from baseline to 12-weeks
  description: Cardiac Function for the participant with Tetralogy of Fallot and d-transposition of the great vessels diagnosis will be assessed with echocardiogram using greyscale 2-dimensional images obtained on the ventricles. Global longitudinal strain analysis will be performed by averaging the apical 4, 3, and 2 images using GE EchoPAC BT13 software following American Society of Echocardiography guidelines.
  measure: Lean Body Mass
  time frame: Change from baseline to 12-weeks
  description: Body composition will be assessed using whole-body dual energy X-ray absorptiometry (DXA)
  measure: Frailty (slowness)
  time frame: Change from baseline to 12-weeks
  description: Slowness will be assessed using a 6-minute walk test
  measure: Frailty (weakness)
  time frame: Change from baseline to 12-weeks
  description: Weakness will be assessed using handgrip strength dynamometry.
  measure: Frailty (fatigue)
  time frame: Change from baseline to 12-weeks
  description: Fatigue will be assessed using the Pediatric quality of life inventory (PedsQL) Multidimensional Fatigue Scale (Range: 0 (high fatigue) - 100 (low fatigue))
  measure: Frailty (energy expenditure/physical activity)
  time frame: Change from baseline to 12-weeks
  description: Physical activity / energy expenditure will be assessed using the self-report, past-week Physical Activity Questionnaire for Adolescents (PAQ-A) (Range: 1 (inactive) - 5 (highly active))
  measure: Functional Movement
  time frame: Change from baseline to 12-weeks
  description: Functional Movement / gross motor proficiency will be assessed with the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (Range: -3SD (well-below average) - +4SD (well-above average)) SD = Standard deviations
  measure: Quality of Life Generic Core Scale
  time frame: Change from baseline to 12-weeks
  description: Quality of life (QoL) will be assessed with the Pediatric Quality of Life inventory (PedsQL) Generic Core Scale (Range: 0 (low QoL) - 100 (high QoL))
  measure: Quality of Life Cardiac Module
  time frame: Change from baseline to 12-weeks
  description: Cardiac specific quality of life (QoL) will be assessed with the Pediatric Quality of Life inventory (PedsQL) Cardiac Module (Range: 0 (low QoL) - 100 (high QoL))
  measure: Physical Activity Self-Efficacy
  time frame: Change from baseline to 12-weeks
  description: Physical activity (PA) self-efficacy will be assessed using the Domain-Specific Physical Activity Efficacy Questionnaire (mean score of 0 (low PA self-efficacy) - 100 (high PA self-efficacy)
  measure: Exercise session adherence (Remote Cardiac Rehab Group)
  time frame: Baseline to 12-weeks
  description: Exercise session adherence will be assessed using a wrist-worn Fitbit Versa 4 activity monitor. The Fitbit Versa 4 will be used to asses exercise heart rates during the exercise sessions.
  measure: Lifestyle Physical Activity
  time frame: Change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention
  description: Physical activity will be assessed using a wrist-worn Fitbit Versa 4 activity monitor. The Fitbit Versa 4 will be used to determine the volume of physical activity participation in free-living conditions.
  arm group label: Remote Cardiac Rehabilitation
  arm group type: Experimental
  description: Following a 2-week ramp-up period, participants will attend group exercise sessions, remotely delivered in their homes, 3 days per week for 45-minutes over 12-weeks led by a live-interactive health coach. There are 4 exercise session types with different modalities: Session A: 75% aerobic, 25% resistance; Session B: 25% aerobic, 75% resistance; Session C: 50% aerobic, 50% resistance; and Session D: Exercise games (mix of modalities). Each participant will rotate through a 5-week set of exercise sessions (20 sessions) twice over the 10-weeks of group exercise period.
  arm group label: Active Control
  arm group type: Active Comparator
  description: Participants will receive a handout describing physical activities appropriate for their congenital heart disease diagnosis and providing recommendations consistent with the physical activity recommendations for children and adolescents.
  intervention type: Behavioral
  intervention name: Remote Cardiac Rehabilitation
  description: Participants will engage in a ramp-up period (weeks 0-2) where participants will attend 1-on-1 live, remote in-home exercise sessions (20-35 min./session, 3-days/wk.) delivered by a health coach via telehealth video conferencing. Participants will be provided a tablet computer and a small set of equipment. Following the ramp-up period, participants will be asked to attend live, in-home, group-based exercise sessions (weeks 3-12, 3-5 participants/group, 45-min, 3-days/wk. minimum). Sessions will be offered 4-days/wk. in the afternoons and early evenings allowing participants to select the most convenient 3 days per week to attend. Sessions will include a variety of dynamic aerobic and anaerobic (resistance) exercises with a target heart rate corresponding to 60-75% of VO2peak. In the group-based exercise sessions, participants will be able to see, hear, and verbally interact with the health coach and the other participants, allowing for supervision and encouraging social support.
  arm group label: Remote Cardiac Rehabilitation
  other name: RCR
  intervention type: Behavioral
  intervention name: Active Control
  description: Participants will receive a handout describing physical activities appropriate for their congenital heart disease diagnosis and providing recommendations consistent with the physical activity recommendations for children and adolescents.
  arm group label: Active Control
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 19 Years
  healthy volunteers: No
  last name: David A White, PhD
  role: Principal Investigator
  affiliation: Children's Mercy Kansas City
  last name: Dara Watkins, MA
  phone: 816-302-3633
  phone ext: 73633
  email: djwatkins@cmh.edu
  last name: David Cloutier, MS, MBA
  phone: 816-302-3636
  email: dacloutier@cmh.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Children's Mercy Hospital Kansas City
  investigator full name: David White
  investigator title: Associate Professor, Exercise Physiologist
  mesh term: Heart Diseases
  mesh term: Heart Defects, Congenital
  sharing ipd: No