<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/NCT04425005</url>
  </required_header>
  <id_info>
    <org_study_id>21056813.3.0000.0068</org_study_id>
    <nct_id>NCT04425005</nct_id>
  </id_info>
  <brief_title>Home-based Exercise Training During Covid-19 Pandemic in Post-bariatric</brief_title>
  <official_title>Effect of Home-based Exercise Training Program During the Covid-19 Pandemic in Post-bariatric Patients: 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>
      The aim of this study is to assess the effect of a home-based exercise training during social&#xD;
      isolation due to covid-19 pandemic in patients who undertook bariatric surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients will be invited to participate in the study by phone call. The research&#xD;
      team will visit the included patients. All patients giving the written consent will perform&#xD;
      the following tests before being randomly allocated into exercise training or control: 1)&#xD;
      blood pressure; 2) anthropometric measures; 3) blood sampling; 4) handgrip test; 5) sit and&#xD;
      stand test; 6) exercise capacity; 7) nutritional recalls and 8) health-related&#xD;
      questionnaires. Patients will be randomized in a 1:1 ratio to control group (will receive&#xD;
      information to keep active and eating healthy) or exercise training group (will receive a&#xD;
      telemonitored exercise program through video conference, three times a week, during 3&#xD;
      months). Following 3 months of intervention, the outocomes will be re-assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2020</start_date>
  <completion_date type="Actual">December 7, 2020</completion_date>
  <primary_completion_date type="Actual">December 7, 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>Change from baseline on waist circumference at 3 months of follow-up.</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Waist circumference will be measured using a steel measuring tape to the nearest 0.1cm at the high point of the iliac crest at minimal respiration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on cardiometabolic risk factor at 3 months of follow-up.</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Cardiometabolic risk will be calculated using mean blood pressure, fasting triglycerides, HDL, waist circumference and fasting glucose. These outocomes will be presented separately as well.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on cardiopulmonary fitness at 3 months of follow-up.</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Cardiopulmonary fitness will be assessed by a validated two-minutes step test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on quality of life at 3 months of follow up.</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Will be evaluated by the SF-36 health survey questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on Physical activity levels at 3 months of follow up.</measure>
    <time_frame>Baseline and 3 months follow-up.</time_frame>
    <description>Will be evaluated by the International Physical Activity Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on dietary intake at 3 months of follow up.</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Will be assessed by 24 hours food intake recall.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Bariatric Surgery</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home-based exercise</intervention_name>
    <description>Home-based exercise training, supervised by videoconference.</description>
    <arm_group_label>Exercise training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women submitted to bariatric surgery in the last 12 months.&#xD;
&#xD;
          -  Not engaged in regular exercise training programs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with &gt;12 months of post-operatory period.&#xD;
&#xD;
          -  Patients with diagnosed mental disorders.&#xD;
&#xD;
          -  Patients with physical limitations or not allowed by the physician to exercise.&#xD;
&#xD;
          -  Patients infected with Covid-19 at the time of data collection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruno Gualano</last_name>
    <role>Principal Investigator</role>
    <affiliation>HC FMUSP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univsersity of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05508-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>January 18, 2021</last_update_submitted>
  <last_update_submitted_qc>January 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</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>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04425005
org study id: 21056813.3.0000.0068
nct id: NCT04425005
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the effect of a home-based exercise training during social
      isolation due to covid-19 pandemic in patients who undertook bariatric surgery.
Eligible patients will be invited to participate in the study by phone call. The research
      team will visit the included patients. All patients giving the written consent will perform
      the following tests before being randomly allocated into exercise training or control: 1)
      blood pressure; 2) anthropometric measures; 3) blood sampling; 4) handgrip test; 5) sit and
      stand test; 6) exercise capacity; 7) nutritional recalls and 8) health-related
      questionnaires. Patients will be randomized in a 1:1 ratio to control group (will receive
      information to keep active and eating healthy) or exercise training group (will receive a
      telemonitored exercise program through video conference, three times a week, during 3
      months). Following 3 months of intervention, the outocomes will be re-assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline on waist circumference at 3 months of follow-up.
time frame: Baseline and 3 months
description: Waist circumference will be measured using a steel measuring tape to the nearest 0.1cm at the high point of the iliac crest at minimal respiration.
measure: Change from baseline on cardiometabolic risk factor at 3 months of follow-up.
time frame: Baseline and 3 months
description: Cardiometabolic risk will be calculated using mean blood pressure, fasting triglycerides, HDL, waist circumference and fasting glucose. These outocomes will be presented separately as well.
measure: Change from baseline on cardiopulmonary fitness at 3 months of follow-up.
time frame: Baseline and 3 months
description: Cardiopulmonary fitness will be assessed by a validated two-minutes step test.
measure: Change from baseline on quality of life at 3 months of follow up.
time frame: Baseline and 3 months
description: Will be evaluated by the SF-36 health survey questionnaire.
measure: Change from baseline on Physical activity levels at 3 months of follow up.
time frame: Baseline and 3 months follow-up.
description: Will be evaluated by the International Physical Activity Questionnaire.
measure: Change from baseline on dietary intake at 3 months of follow up.
time frame: Baseline and 3 months
description: Will be assessed by 24 hours food intake recall.
arm group label: Control group
arm group type: No Intervention
arm group label: Exercise training group
arm group type: Experimental
intervention type: Other
intervention name: Home-based exercise
description: Home-based exercise training, supervised by videoconference.
arm group label: Exercise training group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bruno Gualano
role: Principal Investigator
affiliation: HC FMUSP
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Bruno Gualano
investigator title: Professor
mesh term: COVID-19
sharing ipd: No