<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/NCT04458246</url>
  </required_header>
  <id_info>
    <org_study_id>31314220.5.0000.0068</org_study_id>
    <nct_id>NCT04458246</nct_id>
  </id_info>
  <brief_title>Home-based Aerobic Training Among Adolescents With Chronic Diseases During COVID-19 Pandemic</brief_title>
  <official_title>Online, Home-based, Aerobic Training Program Among Adolescents With Chronic Diseases During COVID-19 Pandemic: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Data show that the coronavirus disease 2019 (COVID-19) symptoms can be severe in 4% and 3% of&#xD;
      the adolescents aged 11-15 years and ≥ 16 years, respectively. In addition, the prevalence of&#xD;
      chronic diseases among adolescents has increased in the last years. About 20% of the&#xD;
      adolescents have some chronic disease, resulting in increased morbidity and mortality. In&#xD;
      march, 2020, the quarantine was officially implemented in Sao Paulo, while elective medical&#xD;
      appointments for adolescents with chronic disease were temporarily suspended. To mitigate the&#xD;
      deleterious effect of the social isolation on physical and mental health among these&#xD;
      patients, this study aims to test the effects of an online, home-based, exercise training&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and efficacy of a home-based exercise training program</measure>
    <time_frame>From baseline to 3 months of follow-up</time_frame>
    <description>Semi structured interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients perceptions during social isolation</measure>
    <time_frame>From baseline to 3 months of follow-up</time_frame>
    <description>Semi structured interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adolescents quality of life</measure>
    <time_frame>From baseline to 3 months of follow-up</time_frame>
    <description>Quality of life will be assessed by means of Pediatric Quality of Life inventory (PedsQLTM 4.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease activity</measure>
    <time_frame>From baseline to 3 months of follow-up</time_frame>
    <description>Will be assessed by means of a visual analog scale (from 0 - no disease activity) to 10 - maximum disease activity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease overall assessment</measure>
    <time_frame>From baseline to 3 months of follow-up</time_frame>
    <description>Will be assessed using the visual analog scale from 0 (very good condition) to 10 (very poor condition).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strengths and difficulties</measure>
    <time_frame>From baseline to 3 months of follow-up</time_frame>
    <description>Will be assessed by means of Strengths &amp; Difficulties Questionnaires</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Chronic Disease</condition>
  <condition>Chronic Diseases in Adolescence</condition>
  <condition>Chronic Disease of Immune System</condition>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 patients from each chronic diseases conditions (1- Inflammatory bowel disease; 2- autoimmune hepatitis; 3- liver transplant; 4- renal transplant; 5- systemic lupus erythematosus; 6- juvenile dermatomyositis; 7- juvenile idiopathic arthritis) will receive an online home-based aerobic training, three times a week, during 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>10 patients from each chronic diseases conditions (1- Inflammatory bowel disease; 2- autoimmune hepatitis; 3- liver transplant; 4- renal transplant; 5- systemic lupus erythematosus; 6- juvenile dermatomyositis; 7- juvenile idiopathic arthritis) will be advised to maintain their daily routine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise training group</intervention_name>
    <description>Online aerobic home-based exercise training, 3 times per week, during 3 months. The exercise program is composed by 3 levels (starter, intermediate and advanced) which be completed in the first, second and third month of intervention, respectively.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Diagnosed with either one of the following chronic conditions:&#xD;
&#xD;
          -  Inflammatory bowel disease;&#xD;
&#xD;
          -  autoimmune hepatitis;&#xD;
&#xD;
          -  liver transplant;&#xD;
&#xD;
          -  renal transplant;&#xD;
&#xD;
          -  systemic lupus erythematosus;&#xD;
&#xD;
          -  juvenile dermatomyositis;&#xD;
&#xD;
          -  juvenile idiopathic arthritis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with physical limitations that preclude exercise.&#xD;
&#xD;
          -  Patients diagnosed with COVID-19.&#xD;
&#xD;
          -  Patients diagnosed with mental disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bruno Gualano, PhD</last_name>
    <phone>+55 11 3061-8789</phone>
    <email>gualano@usp.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Univsersity of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05508-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruno Gualano, Phd</last_name>
      <phone>551130918783</phone>
      <email>gualano@usp.br</email>
    </contact>
    <investigator>
      <last_name>Bruno Gualano, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Bruno Gualano</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Immune System Diseases</mesh_term>
    <mesh_term>Chronic Disease</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/NCT04458246
org study id: 31314220.5.0000.0068
nct id: NCT04458246
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Data show that the coronavirus disease 2019 (COVID-19) symptoms can be severe in 4% and 3% of
      the adolescents aged 11-15 years and ≥ 16 years, respectively. In addition, the prevalence of
      chronic diseases among adolescents has increased in the last years. About 20% of the
      adolescents have some chronic disease, resulting in increased morbidity and mortality. In
      march, 2020, the quarantine was officially implemented in Sao Paulo, while elective medical
      appointments for adolescents with chronic disease were temporarily suspended. To mitigate the
      deleterious effect of the social isolation on physical and mental health among these
      patients, this study aims to test the effects of an online, home-based, exercise training
      program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Safety and efficacy of a home-based exercise training program
time frame: From baseline to 3 months of follow-up
description: Semi structured interview
measure: Patients perceptions during social isolation
time frame: From baseline to 3 months of follow-up
description: Semi structured interview
measure: Adolescents quality of life
time frame: From baseline to 3 months of follow-up
description: Quality of life will be assessed by means of Pediatric Quality of Life inventory (PedsQLTM 4.0)
measure: Disease activity
time frame: From baseline to 3 months of follow-up
description: Will be assessed by means of a visual analog scale (from 0 - no disease activity) to 10 - maximum disease activity).
measure: Disease overall assessment
time frame: From baseline to 3 months of follow-up
description: Will be assessed using the visual analog scale from 0 (very good condition) to 10 (very poor condition).
measure: Strengths and difficulties
time frame: From baseline to 3 months of follow-up
description: Will be assessed by means of Strengths & Difficulties Questionnaires
arm group label: Intervention
arm group type: Experimental
description: 10 patients from each chronic diseases conditions (1- Inflammatory bowel disease; 2- autoimmune hepatitis; 3- liver transplant; 4- renal transplant; 5- systemic lupus erythematosus; 6- juvenile dermatomyositis; 7- juvenile idiopathic arthritis) will receive an online home-based aerobic training, three times a week, during 3 months.
arm group label: Control
arm group type: No Intervention
description: 10 patients from each chronic diseases conditions (1- Inflammatory bowel disease; 2- autoimmune hepatitis; 3- liver transplant; 4- renal transplant; 5- systemic lupus erythematosus; 6- juvenile dermatomyositis; 7- juvenile idiopathic arthritis) will be advised to maintain their daily routine.
intervention type: Other
intervention name: Exercise training group
description: Online aerobic home-based exercise training, 3 times per week, during 3 months. The exercise program is composed by 3 levels (starter, intermediate and advanced) which be completed in the first, second and third month of intervention, respectively.
arm group label: Intervention
criteria: 
gender: All
minimum age: 10 Years
maximum age: 19 Years
healthy volunteers: No
last name: Bruno Gualano, PhD
phone: +55 11 3061-8789
email: gualano@usp.br
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Bruno Gualano
investigator title: Dr
mesh term: COVID-19
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Immune System Diseases
mesh term: Chronic Disease