<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/NCT04451317</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/20/0203</org_study_id>
    <nct_id>NCT04451317</nct_id>
  </id_info>
  <brief_title>Physical Activity Following the Containment Period Imposed by the COVID-19 Pandemic in Patients</brief_title>
  <acronym>PhysiCOVID</acronym>
  <official_title>Changes in Physical and Sports Activity, Anxiety and Sleep Patterns Following the Containment Period Imposed by the COVID-19 Pandemic in Patients With Chronic Medical Conditions and in Healthy Athletes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      In the context of the containment imposed by the COVID-19 pandemic and taking into account&#xD;
      the numerous restrictions imposed, the practice of physical and sports activities (PSA) could&#xD;
      be reduced by general population and sports population. While the practice of regular&#xD;
      physical activity (PA) is prescribed and widely recognized as effective for the management of&#xD;
      many chronic conditions and that regular participation in sports (SA) reduces the risk of&#xD;
      injury and cardiac accidents- vascular disease in sports subjects, the reduction in regular&#xD;
      physical activity levels in the wake of the period of confinement is likely to induce a&#xD;
      medical risk in connection with the resumption of PSA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is non-interventional. The data that will be collected are data that can be&#xD;
      integrated into a care procedure in accordance with the recommendations to accompany the&#xD;
      patients with chronic pathology and athletes for the resumption of PSA after hypothetical&#xD;
      deconditioning. Support will be implemented in accordance with the recommendations of the&#xD;
      HCSP and the Ministry of Sports. The objective of this study is to evaluate the data of this&#xD;
      recommended medical follow-up.&#xD;
&#xD;
      The questionnaires used for the subjects' self-evaluation are all validated in French&#xD;
      language, used in the context of medical monitoring, and used in clinical research:&#xD;
      assessment of physical activity levels by the questionnaire of RICCI and GAGNON (RG),&#xD;
      evaluation of the level of Anxiety and Depression by the Hospital and Anxiety Scale&#xD;
      Depression (AHH), assessment of sleep quality by the score of LEEDS.&#xD;
&#xD;
      Medical questionnaires to assess the evolutionary stage of chronic pathologies (MS,&#xD;
      Parkinson's disease and Fibromyalgia) will be informed by the investigating physician during&#xD;
      the interview telephone with the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity measure</measure>
    <time_frame>1 day</time_frame>
    <description>Changes in the level of physical activity (questionnaire from RICCI-GAGNON)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>1 day</time_frame>
    <description>To evaluate the f the level of anxiety and depression by questionnaire HAD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>1 day</time_frame>
    <description>To evaluate the level of sleep activity by questionnaire LEEDS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>food activity</measure>
    <time_frame>1 day</time_frame>
    <description>To evaluate the food activity by questionnaire LEEDS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>activity level of chronic pathology</measure>
    <time_frame>1 day</time_frame>
    <description>To evaluate of the activity level of chronic pathology (monitoring criteria in accordance with good clinical practice) in patients with chronic pathology by questionnaire</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">499</enrollment>
  <condition>Physical Activity</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <description>Patients involved in a Sport-Health initiative Visit once by telephone and then ask to fill in 3 questionnaires on a digital platform within 48 hours after the telephone interview.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Healthy sport subjects. Visit once by telephone and then ask to fill in 3 questionnaires on a digital platform within 48 hours after the telephone interview.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire, phone call</intervention_name>
    <description>phone call and 3 questionnaires on a digital platform</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        healthy athletes or patients involved in a Sport-health initiative&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-working or tele-working subjects, subjects who have returned to work, subjects who&#xD;
             have taken up a part-time professional activity, subjects who have resumed an activity&#xD;
             full-time professional&#xD;
&#xD;
          -  subjects who have given their consent&#xD;
&#xD;
          -  for the sports topics group: amateur level (no sportsmen and women professionals),&#xD;
             including sports subjects in the disabled category, with no chronic pathology, already&#xD;
             followed by the investigating medical units.&#xD;
&#xD;
          -  for the group of patients with chronic diseases: subjects carrying a chronic pathology&#xD;
             (rheumatic pathologies, etc) and fibromyalgia, Parkinson's disease and multiple&#xD;
             sclerosis, cancer of the breast, metabolic diseases without cardiovascular failure)&#xD;
             usually accompanied by the medical units for the implementation of a programme of&#xD;
             physic adapted and medically prescribed (Sport-Santé approach)&#xD;
&#xD;
          -  social security affiliation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under the protection of adults (guardianship, curators), safeguard of&#xD;
             justice),&#xD;
&#xD;
          -  Pregnant and/or breastfeeding woman.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Fabien Pillard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hopsital Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anxiety</keyword>
  <keyword>sleep</keyword>
  <keyword>chronic pathology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04451317
org study id: RC31/20/0203
nct id: NCT04451317
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In the context of the containment imposed by the COVID-19 pandemic and taking into account
      the numerous restrictions imposed, the practice of physical and sports activities (PSA) could
      be reduced by general population and sports population. While the practice of regular
      physical activity (PA) is prescribed and widely recognized as effective for the management of
      many chronic conditions and that regular participation in sports (SA) reduces the risk of
      injury and cardiac accidents- vascular disease in sports subjects, the reduction in regular
      physical activity levels in the wake of the period of confinement is likely to induce a
      medical risk in connection with the resumption of PSA.
The study is non-interventional. The data that will be collected are data that can be
      integrated into a care procedure in accordance with the recommendations to accompany the
      patients with chronic pathology and athletes for the resumption of PSA after hypothetical
      deconditioning. Support will be implemented in accordance with the recommendations of the
      HCSP and the Ministry of Sports. The objective of this study is to evaluate the data of this
      recommended medical follow-up.

      The questionnaires used for the subjects' self-evaluation are all validated in French
      language, used in the context of medical monitoring, and used in clinical research:
      assessment of physical activity levels by the questionnaire of RICCI and GAGNON (RG),
      evaluation of the level of Anxiety and Depression by the Hospital and Anxiety Scale
      Depression (AHH), assessment of sleep quality by the score of LEEDS.

      Medical questionnaires to assess the evolutionary stage of chronic pathologies (MS,
      Parkinson's disease and Fibromyalgia) will be informed by the investigating physician during
      the interview telephone with the patient.
observational model: Case-Control
time perspective: Prospective
measure: Physical activity measure
time frame: 1 day
description: Changes in the level of physical activity (questionnaire from RICCI-GAGNON)
measure: Depression
time frame: 1 day
description: To evaluate the f the level of anxiety and depression by questionnaire HAD
measure: Sleep quality
time frame: 1 day
description: To evaluate the level of sleep activity by questionnaire LEEDS
measure: food activity
time frame: 1 day
description: To evaluate the food activity by questionnaire LEEDS
measure: activity level of chronic pathology
time frame: 1 day
description: To evaluate of the activity level of chronic pathology (monitoring criteria in accordance with good clinical practice) in patients with chronic pathology by questionnaire
arm group label: Experimental
description: Patients involved in a Sport-Health initiative Visit once by telephone and then ask to fill in 3 questionnaires on a digital platform within 48 hours after the telephone interview.
arm group label: Control
description: Healthy sport subjects. Visit once by telephone and then ask to fill in 3 questionnaires on a digital platform within 48 hours after the telephone interview.
intervention type: Other
intervention name: Questionnaire, phone call
description: phone call and 3 questionnaires on a digital platform
arm group label: Control
arm group label: Experimental
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Fabien Pillard, MD
role: Principal Investigator
affiliation: University Hopsital Toulouse
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19