<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/NCT04400461</url>
  </required_header>
  <id_info>
    <org_study_id>165/20</org_study_id>
    <nct_id>NCT04400461</nct_id>
  </id_info>
  <brief_title>Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation</brief_title>
  <official_title>Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation: an Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</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>
      Little is known about the physical function outcomes in patients with severe COVID-19&#xD;
      patients who are admitted to Intensive Care Unit (ICU) for invasive mechanical ventilation.&#xD;
      The purpose of this study is to evaluate the short-term impact on physical function before&#xD;
      hospital discharge in subjects with severe COVID-19 who have survived ICU admission for&#xD;
      invasive mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      DESIGN: An observation cohort study conducted in a tertiary hospital.&#xD;
&#xD;
      METHODS: Data will be collected from patients along the ICU-hospital discharge continuum,&#xD;
      will be analysed and non-parametric tests will be used to explore association between&#xD;
      variables.&#xD;
&#xD;
      Outcome measures: Muscle strength, as a component of physical function, will be evaluated&#xD;
      with the Medical Research Council sum score (MRC- SS) at discharge from ICU and at hospital&#xD;
      discharge; the Functional Status Score for the ICU (FSS-ICU) will also be assessed at&#xD;
      hospital discharge. Data on participants' demographics, ICU admission and hospital admission&#xD;
      will also be collected.&#xD;
&#xD;
      SIGNIFICANCE OF THE RESEARCH: Understanding how physical function is affected in patients&#xD;
      with severe COVID-19 may help develop future prevention, therapeutic and follow-up strategies&#xD;
      that improve quality of care and outcomes in this specific group of patients. Findings from&#xD;
      this study may be useful to design future larger cohort studies and experimental trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 25, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Medical Research Council sum score (MRC- SS).</measure>
    <time_frame>&lt; 48 hours before ICU discharge</time_frame>
    <description>Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical Research Council sum score (MRC- SS).</measure>
    <time_frame>&lt; 24 hours before hospital discharge</time_frame>
    <description>Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Functional Status Score for the ICU (FSS-ICU)</measure>
    <time_frame>&lt; 24 hours before hospital discharge</time_frame>
    <description>The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks. Each task is evaluated using an 8-point ordinal scale ranging from 0 (not able to perform) to 7 (complete independence).The total FSS-ICU score ranges from 0 to 35, with higher scores indicating better physical functioning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Age</measure>
    <time_frame>Through study completion, up to 6 months</time_frame>
    <description>Age in years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sex</measure>
    <time_frame>Throughout study completion , up to 6 month</time_frame>
    <description>Male vs Female</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>Throughout study completion, up to 6 months</time_frame>
    <description>kg/m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline mobility</measure>
    <time_frame>First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.</time_frame>
    <description>Baseline mobility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APACHE II score</measure>
    <time_frame>&lt;24 hours after ICU admission</time_frame>
    <description>Acute Physiology and Chronic Health Evaluation II score.The APACHE II score ranges from 0 to 71 points. Higher scores correspond to more severe disease and a higher risk of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in ICU</measure>
    <time_frame>Throughout the study completion, up to 6 months</time_frame>
    <description>Number of days of stay in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days on mechanical ventilation</measure>
    <time_frame>Throughout the study completion, up to 6 months</time_frame>
    <description>Number of days on mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Polyneuropathy diagnosis</measure>
    <time_frame>Throughout the study completion, up to 6 months</time_frame>
    <description>Clinical or EMG polyneuropathy diagnosis confirmation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days on Neuromuscular Blockers</measure>
    <time_frame>Throughout the study completion, up to 6 months</time_frame>
    <description>Number of days on NMB during mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Episodes of prone positioning</measure>
    <time_frame>Throughout the study completion, up to 6 months</time_frame>
    <description>Number of prone positioning episodes during ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospital</measure>
    <time_frame>Throughout the study completion, up to 6 months</time_frame>
    <description>Total number of days admitted to hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuation of care</measure>
    <time_frame>Throughout the study completion, up to 6 months</time_frame>
    <description>Home with no follow-up physiotherapy, home with domiciliary or out-patient physiotherapy, rehabilitation facility, care home, transfer to another acute hospital.</description>
  </secondary_outcome>
  <enrollment type="Actual">71</enrollment>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection and clinical testing of subjects</intervention_name>
    <description>Clinical Testing: muscle strength. Muscle strength, as a component of physical function, will be assessed with the Medical Research Council sum score (MRC- SS) at discharge from the ICU and at discharge from the hospital.&#xD;
Clinical testing: physical function. The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks at discharge from hospital.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects diagnosed with COVID-19 who require admission to the ICU for invasive mechanical&#xD;
        ventilation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects diagnosed with COVID-19 who have required admission to ICU for invasive&#xD;
             mechanical ventilation;&#xD;
&#xD;
          -  have received invasive ventilation &gt; 24 hours;&#xD;
&#xD;
          -  have been successfully weaned from mechanical ventilation &gt; 48 hours;&#xD;
&#xD;
          -  were independently able to mobilise prior to current hospital admission (this includes&#xD;
             subjects who used a walking stick or another gait aid to mobilise.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects or proxies with inability to communicate in Spanish fluently;&#xD;
&#xD;
          -  cognitive impairment prior to ICU admission;&#xD;
&#xD;
          -  proven neurological impairment or neuromuscular disorder;&#xD;
&#xD;
          -  Cerebrovascular Accident during hospital stay;&#xD;
&#xD;
          -  previous organ transplant;&#xD;
&#xD;
          -  pregnancy;&#xD;
&#xD;
          -  unstable fractures or any other injuries that would require medical bed rest.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Medical ICU. Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Surgical ICU. Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</investigator_affiliation>
    <investigator_full_name>Maria Natividad Seisdedos Nunez</investigator_full_name>
    <investigator_title>Physiotherapist, MSc</investigator_title>
  </responsible_party>
  <keyword>physical function</keyword>
  <keyword>functional outcomes</keyword>
  <keyword>strength</keyword>
  <keyword>intensive care unit</keyword>
  <keyword>rehabilitation</keyword>
  <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/NCT04400461
org study id: 165/20
nct id: NCT04400461
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Little is known about the physical function outcomes in patients with severe COVID-19
      patients who are admitted to Intensive Care Unit (ICU) for invasive mechanical ventilation.
      The purpose of this study is to evaluate the short-term impact on physical function before
      hospital discharge in subjects with severe COVID-19 who have survived ICU admission for
      invasive mechanical ventilation.
DESIGN: An observation cohort study conducted in a tertiary hospital.

      METHODS: Data will be collected from patients along the ICU-hospital discharge continuum,
      will be analysed and non-parametric tests will be used to explore association between
      variables.

      Outcome measures: Muscle strength, as a component of physical function, will be evaluated
      with the Medical Research Council sum score (MRC- SS) at discharge from ICU and at hospital
      discharge; the Functional Status Score for the ICU (FSS-ICU) will also be assessed at
      hospital discharge. Data on participants' demographics, ICU admission and hospital admission
      will also be collected.

      SIGNIFICANCE OF THE RESEARCH: Understanding how physical function is affected in patients
      with severe COVID-19 may help develop future prevention, therapeutic and follow-up strategies
      that improve quality of care and outcomes in this specific group of patients. Findings from
      this study may be useful to design future larger cohort studies and experimental trials.
observational model: Cohort
time perspective: Cross-Sectional
measure: Medical Research Council sum score (MRC- SS).
time frame: < 48 hours before ICU discharge
description: Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.
measure: Medical Research Council sum score (MRC- SS).
time frame: < 24 hours before hospital discharge
description: Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.
measure: The Functional Status Score for the ICU (FSS-ICU)
time frame: < 24 hours before hospital discharge
description: The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks. Each task is evaluated using an 8-point ordinal scale ranging from 0 (not able to perform) to 7 (complete independence).The total FSS-ICU score ranges from 0 to 35, with higher scores indicating better physical functioning.
measure: Age
time frame: Through study completion, up to 6 months
description: Age in years
measure: Sex
time frame: Throughout study completion , up to 6 month
description: Male vs Female
measure: Body Mass Index
time frame: Throughout study completion, up to 6 months
description: kg/m2
measure: Baseline mobility
time frame: First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
description: Baseline mobility
measure: APACHE II score
time frame: <24 hours after ICU admission
description: Acute Physiology and Chronic Health Evaluation II score.The APACHE II score ranges from 0 to 71 points. Higher scores correspond to more severe disease and a higher risk of death.
measure: Length of stay in ICU
time frame: Throughout the study completion, up to 6 months
description: Number of days of stay in ICU
measure: Number of days on mechanical ventilation
time frame: Throughout the study completion, up to 6 months
description: Number of days on mechanical ventilation
measure: Polyneuropathy diagnosis
time frame: Throughout the study completion, up to 6 months
description: Clinical or EMG polyneuropathy diagnosis confirmation
measure: Number of days on Neuromuscular Blockers
time frame: Throughout the study completion, up to 6 months
description: Number of days on NMB during mechanical ventilation
measure: Episodes of prone positioning
time frame: Throughout the study completion, up to 6 months
description: Number of prone positioning episodes during ICU stay
measure: Length of stay in hospital
time frame: Throughout the study completion, up to 6 months
description: Total number of days admitted to hospital
measure: Continuation of care
time frame: Throughout the study completion, up to 6 months
description: Home with no follow-up physiotherapy, home with domiciliary or out-patient physiotherapy, rehabilitation facility, care home, transfer to another acute hospital.
intervention type: Other
intervention name: Data collection and clinical testing of subjects
description: Clinical Testing: muscle strength. Muscle strength, as a component of physical function, will be assessed with the Medical Research Council sum score (MRC- SS) at discharge from the ICU and at discharge from the hospital.
Clinical testing: physical function. The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks at discharge from hospital.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
investigator full name: Maria Natividad Seisdedos Nunez
investigator title: Physiotherapist, MSc
mesh term: COVID-19
sharing ipd: No