<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/NCT03275844</url>
  </required_header>
  <id_info>
    <org_study_id>2017-01</org_study_id>
    <nct_id>NCT03275844</nct_id>
  </id_info>
  <brief_title>Physical Capacity and Activity in Children With Congenital Heart Disease</brief_title>
  <official_title>Physical Capacity and Activity in Children With Congenital Heart Disease in Chile</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rodrigo Torres</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chile</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>
      Congenital malformations correspond to defects in organ morphogenesis identifiable at birth&#xD;
      or intrauterine life, affecting 2-3% of births. Inside of these malformations, Congenital&#xD;
      Heart Disease corresponds, in particular, to structural defects of the heart or major blood&#xD;
      vessels thereof may or may not be associated with other types of syndromes.The resolution is&#xD;
      usually surgical.&#xD;
&#xD;
      Also, these patients present a decrease in physical fitness, psychological imbalance, lower&#xD;
      quality of life and risk significant morbidity and mortality from respiratory infections&#xD;
      among other problems.&#xD;
&#xD;
      This can have severe consequences for health in the medium and long term. The habits acquired&#xD;
      during childhood and adolescence are determinant for the adult life, being relevant levels of&#xD;
      activity and physical condition, especially in children with pathologies.&#xD;
&#xD;
      In this way, it is vital to know from childhood parameters that indicate the baseline state&#xD;
      of these patients according to the levels of physical activity, exercise capacity,&#xD;
      nutritional status and quality of life. These will be key indicators to take into account in&#xD;
      the future, to adapt rehabilitation plans that will reduce the effects of their condition.&#xD;
&#xD;
      The objective of this protocol is To characterize the levels of Activity, and Physical&#xD;
      Capacity of children with congenital heart disease regularly treated at the Cardiovascular&#xD;
      Center of Dr. Luis Hospital Calvo Mackenna, compared to healthy children matched by age and&#xD;
      sex.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Moderate-to-vigorous physical activity</measure>
    <time_frame>1 week</time_frame>
    <description>Time in minutes of Moderate-to-vigorous physical activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Six minute walking test</measure>
    <time_frame>1 hour</time_frame>
    <description>Walked distance in six minute walking test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steps</measure>
    <time_frame>1 week</time_frame>
    <description>mean of number of steps per day</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">17</enrollment>
  <condition>Heart Defects, Congenital</condition>
  <condition>Tetralogy of Fallot</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Children with congenital heart disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Control healthy subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physical activity assessment</intervention_name>
    <description>Assessment of Moderate-to-vigorous physical activity</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with congenital heart diseases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with Tetralogy of Fallot corrected&#xD;
&#xD;
          -  Age from 6 to 15 years&#xD;
&#xD;
          -  Assistants to periodic control at HLCM Cardiovascular Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Morbid obesity&#xD;
&#xD;
          -  Musculoskeletal disorders that impede physical activity&#xD;
&#xD;
          -  Neurological comorbidity&#xD;
&#xD;
          -  Respiratory comorbidity in the last 30 days.&#xD;
&#xD;
          -  Pacemaker users&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Homero Puppo, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Univeridad de Chile</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roberto M Acosta, MSc</last_name>
    <phone>56984123384</phone>
    <email>acostadighero@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rodrigo Torres, MSc</last_name>
    <phone>56992431383</phone>
    <email>klgorodrigotorres@gmail.com</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Rodrigo Torres</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Physical capacity</keyword>
  <keyword>Children</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>
    <mesh_term>Tetralogy of Fallot</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Probably, All information will be public</ipd_description>
  </patient_data>
  <!-- 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/NCT03275844
org study id: 2017-01
nct id: NCT03275844
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Congenital malformations correspond to defects in organ morphogenesis identifiable at birth
      or intrauterine life, affecting 2-3% of births. Inside of these malformations, Congenital
      Heart Disease corresponds, in particular, to structural defects of the heart or major blood
      vessels thereof may or may not be associated with other types of syndromes.The resolution is
      usually surgical.

      Also, these patients present a decrease in physical fitness, psychological imbalance, lower
      quality of life and risk significant morbidity and mortality from respiratory infections
      among other problems.

      This can have severe consequences for health in the medium and long term. The habits acquired
      during childhood and adolescence are determinant for the adult life, being relevant levels of
      activity and physical condition, especially in children with pathologies.

      In this way, it is vital to know from childhood parameters that indicate the baseline state
      of these patients according to the levels of physical activity, exercise capacity,
      nutritional status and quality of life. These will be key indicators to take into account in
      the future, to adapt rehabilitation plans that will reduce the effects of their condition.

      The objective of this protocol is To characterize the levels of Activity, and Physical
      Capacity of children with congenital heart disease regularly treated at the Cardiovascular
      Center of Dr. Luis Hospital Calvo Mackenna, compared to healthy children matched by age and
      sex.
observational model: Other
time perspective: Cross-Sectional
measure: Moderate-to-vigorous physical activity
time frame: 1 week
description: Time in minutes of Moderate-to-vigorous physical activity
measure: Six minute walking test
time frame: 1 hour
description: Walked distance in six minute walking test
measure: Steps
time frame: 1 week
description: mean of number of steps per day
arm group label: Group 1
description: Children with congenital heart disease
arm group label: Group 2
description: Control healthy subjects
intervention type: Procedure
intervention name: Physical activity assessment
description: Assessment of Moderate-to-vigorous physical activity
arm group label: Group 1
arm group label: Group 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Homero Puppo, MSc
role: Study Chair
affiliation: Univeridad de Chile
last name: Roberto M Acosta, MSc
phone: 56984123384
email: acostadighero@gmail.com
last name: Rodrigo Torres, MSc
phone: 56992431383
email: klgorodrigotorres@gmail.com
responsible party type: Sponsor-Investigator
investigator affiliation: University of Chile
investigator full name: Rodrigo Torres
investigator title: Assistant Professor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
mesh term: Tetralogy of Fallot
mesh term: Congenital Abnormalities
sharing ipd: Undecided
ipd description: Probably, All information will be public