<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/NCT04503486</url>
  </required_header>
  <id_info>
    <org_study_id>MQV-USI</org_study_id>
    <nct_id>NCT04503486</nct_id>
  </id_info>
  <brief_title>Relationship Between Muscle Strength and Quality of Life in ICU Survivors</brief_title>
  <official_title>Relationship Between Grip and Quadriceps Strength on Quality of Life in ICU Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</source>
  <oversight_info>
    <has_dmc>No</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 aim is to study the impact of muscle strength measured in ICU and after ICU discharge on&#xD;
      health-related quality of life measured after hospital discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>health-related quality of life</measure>
    <time_frame>1 month after ICU discharge</time_frame>
    <description>assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>health-related quality of life</measure>
    <time_frame>3 months after ICU discharge</time_frame>
    <description>assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>health-related quality of life</measure>
    <time_frame>6 months after ICU discharge</time_frame>
    <description>assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>health-related quality of life</measure>
    <time_frame>1 month after ICU discharge</time_frame>
    <description>assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>health-related quality of life</measure>
    <time_frame>3 months after ICU discharge</time_frame>
    <description>assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>health-related quality of life</measure>
    <time_frame>6 months after ICU discharge</time_frame>
    <description>assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Critical Illness</condition>
  <condition>Muscle Strength</condition>
  <condition>Quadriceps Strength</condition>
  <condition>Grip Strength</condition>
  <condition>Quality of Life</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>handgrip strength</intervention_name>
    <description>measure of handgrip strength using Jamar Dynamometer and a standardized protocol, strength expressed in kg</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>quadriceps strength</intervention_name>
    <description>maximal isometric quadriceps strength measured using a handheld dynamometer and a standardized protocol, strength expressed in Newton</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        the study includes patients in ICU after a stay of at least 7 days. They are included as&#xD;
        soon as they are collaborative.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  critically ill patients with an ICU stay of at least 7 days&#xD;
&#xD;
          -  collaborative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non collaborative, confusion, coma&#xD;
&#xD;
          -  limb paresis or plegia&#xD;
&#xD;
          -  patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anne-Françoise Rousseau, MD, PhD</last_name>
    <phone>+3243667495</phone>
    <email>afrousseau@chuliege.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital of Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Françoise Rousseau, PhD</last_name>
      <phone>+3243667495</phone>
      <email>afrousseau@chuliege.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 9, 2020</last_update_submitted>
  <last_update_submitted_qc>August 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Rousseau</investigator_full_name>
    <investigator_title>head of clinic</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT04503486
org study id: MQV-USI
nct id: NCT04503486
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim is to study the impact of muscle strength measured in ICU and after ICU discharge on
      health-related quality of life measured after hospital discharge.
observational model: Cohort
time perspective: Prospective
measure: health-related quality of life
time frame: 1 month after ICU discharge
description: assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses
measure: health-related quality of life
time frame: 3 months after ICU discharge
description: assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses
measure: health-related quality of life
time frame: 6 months after ICU discharge
description: assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses
measure: health-related quality of life
time frame: 1 month after ICU discharge
description: assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
measure: health-related quality of life
time frame: 3 months after ICU discharge
description: assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
measure: health-related quality of life
time frame: 6 months after ICU discharge
description: assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
intervention type: Diagnostic Test
intervention name: handgrip strength
description: measure of handgrip strength using Jamar Dynamometer and a standardized protocol, strength expressed in kg
intervention type: Diagnostic Test
intervention name: quadriceps strength
description: maximal isometric quadriceps strength measured using a handheld dynamometer and a standardized protocol, strength expressed in Newton
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne-Françoise Rousseau, MD, PhD
phone: +3243667495
email: afrousseau@chuliege.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Rousseau
investigator title: head of clinic
mesh term: Critical Illness
sharing ipd: No