<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/NCT03771014</url>
  </required_header>
  <id_info>
    <org_study_id>UHSEmpress</org_study_id>
    <nct_id>NCT03771014</nct_id>
  </id_info>
  <brief_title>A Feasibility Study of Early Mobilisation Programmes in Critical Care</brief_title>
  <acronym>EMPRESS</acronym>
  <official_title>EMPRESS: A Feasibility Study of Early Mobilisation Programmes in Critical Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Southampton NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</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 objective of this study is to determine the feasibility of delivering a very early&#xD;
      mobility rehabilitation program in Intensive Care Units (ICU), within the context of a&#xD;
      randomised controlled trial (RCT). This will inform the design of a future RCT investigating&#xD;
      very early ICU rehabilitation in the UK National Health Service.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early ICU-based physical rehabilitation may benefit patients with acute severe respiratory&#xD;
      failure by attenuating the development of severe and persistent weakness and impaired&#xD;
      physical function seen in these patients.&#xD;
&#xD;
      Muscle wasting occurs early (within 12 hours) and progresses rapidly after ICU admission.&#xD;
      Patients may suffer from consequent physical impairment for months or years following their&#xD;
      discharge.&#xD;
&#xD;
      ICU based rehabilitation has the potential to improve physical function outcomes, through&#xD;
      mitigating muscle wasting.&#xD;
&#xD;
      The investigators have successfully introduced a very early ICU mobility program in their&#xD;
      institution, which results in increased ventilator free days and reduced length of ICU stay.&#xD;
&#xD;
      The primary aim is to investigate whether this method will work in other ICUs. EMPRESS will&#xD;
      test the feasibility of running this intervention as an RCT. The results and a concurrent&#xD;
      process evaluation will inform the design of a future, multi-centre randomised controlled&#xD;
      trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2019</start_date>
  <completion_date type="Actual">September 23, 2022</completion_date>
  <primary_completion_date type="Actual">September 23, 2022</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>
    <intervention_model_description>Feasibility study of two-arm pilot RCT, randomised 1:1 with blinded outcome assessments</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome assessment at ICU discharge, hospital discharge and 3 month follow-up will be undertaken by an assessor, blinded to study group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Function ICU Test-scored</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>This is a reliable and valid 4 item scale ( arm strength, leg strength, ability to stand and step cadence),with a score range of 0-10 and is responsive to change and predictive of key outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical Research Council Manual Muscle Test Sum Score ( MRC-ss)</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Test of muscle strength and function, where full strength is defined as a score of 60/60 and ICU-AW as a score of &lt;48/60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand held dynamometry (HHD)</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Assessment of hand grip strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chelsea Critical Care Physical Assessment tool (CPAX)</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>This validated tool reliably grades physical morbidity from complete&#xD;
dependence on admission though progressive independence. Scores on ICU discharge may predict recovery trajectory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Mobility Scale</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Best level of function achieved in ICU using an 11-point ordinal scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and go</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Frailty Score</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>An 8 point score to classify patients as fit, vulnerable or frail and correlates with outcome in both elderly and younger patients. Pre illness frailty will be assessed by proxy on admission from information gathered from family member /NOK and from patient at the 3 follow-up assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel Index for Activities of Daily Living</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Barthel ADL index is an ordinal scale used to measure performance in activities of daily living (ADL).&#xD;
Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six minute walk test</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Widely used to assess functional exercise capacity in patients following an ICU admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Hospital Anxiety and Depression Scale - HADS</measure>
    <time_frame>6 months</time_frame>
    <description>Measure of anxiety and depression in general medical population of patients. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)</measure>
    <time_frame>6 months</time_frame>
    <description>A generic assessment instrument for health and disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>6 months</time_frame>
    <description>The descriptive system comprises self-assessment of five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.&#xD;
The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Early mobility</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive standard physiotherapy regimen plus 2 x 30 minute rehabilitation sessions 5 days per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive standard physiotherapy regimen</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early mobility</intervention_name>
    <description>This progressive mobility pathway commenced with passive cycling within 48 hours of intubation and ventilation and progressing through assisted cycling, active cycling, bed exercises, sitting, mobilising out of bed to walking</description>
    <arm_group_label>Early mobility</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute/unplanned medical admissions to the ICU.&#xD;
&#xD;
          -  &gt; 42 years old.&#xD;
&#xD;
          -  Functionally independent prior to ICU admission (Barthel &gt;80).&#xD;
&#xD;
          -  In hospital for &lt;5 days prior to intubation and ventilation.&#xD;
&#xD;
          -  Intubated and ventilated for &lt;72 hrs.&#xD;
&#xD;
          -  Expected to remain ventilated for a further 48 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In hospital for 5 days or more prior to ITU admission.&#xD;
&#xD;
          -  Patients with acute brain or spinal cord injury.&#xD;
&#xD;
          -  Known or suspected neurological / muscular impairment.&#xD;
&#xD;
          -  Condition limiting use of cycle ergometer e.g. lower limb fracture / amputation.&#xD;
&#xD;
          -  Not expected to survive &gt;48hrs.&#xD;
&#xD;
          -  Persistent therapy exemptions in first 3 days of mechanical ventilation.&#xD;
&#xD;
          -  Body habitus such as unable to use cycle ergometer.&#xD;
&#xD;
          -  Consultant clinician view that patient not suitable or not expected to survive&#xD;
             admission.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>42 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca Cusack, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Southampton NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medway NHS Foundation Trust</name>
      <address>
        <city>Gillingham</city>
        <state>Kent</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intensive care</keyword>
  <keyword>physiotherapy</keyword>
  <keyword>rehabilitation</keyword>
  <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>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results manuscript will be de-identified and shared on request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Immediately following publication. No end date.</ipd_time_frame>
    <ipd_access_criteria>Proposals should be addressed to EMPRESS@uhs.nhs.uk</ipd_access_criteria>
  </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/NCT03771014
org study id: UHSEmpress
nct id: NCT03771014
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to determine the feasibility of delivering a very early
      mobility rehabilitation program in Intensive Care Units (ICU), within the context of a
      randomised controlled trial (RCT). This will inform the design of a future RCT investigating
      very early ICU rehabilitation in the UK National Health Service.
Early ICU-based physical rehabilitation may benefit patients with acute severe respiratory
      failure by attenuating the development of severe and persistent weakness and impaired
      physical function seen in these patients.

      Muscle wasting occurs early (within 12 hours) and progresses rapidly after ICU admission.
      Patients may suffer from consequent physical impairment for months or years following their
      discharge.

      ICU based rehabilitation has the potential to improve physical function outcomes, through
      mitigating muscle wasting.

      The investigators have successfully introduced a very early ICU mobility program in their
      institution, which results in increased ventilator free days and reduced length of ICU stay.

      The primary aim is to investigate whether this method will work in other ICUs. EMPRESS will
      test the feasibility of running this intervention as an RCT. The results and a concurrent
      process evaluation will inform the design of a future, multi-centre randomised controlled
      trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Feasibility study of two-arm pilot RCT, randomised 1:1 with blinded outcome assessments
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Outcome assessment at ICU discharge, hospital discharge and 3 month follow-up will be undertaken by an assessor, blinded to study group allocation.
measure: Physical Function ICU Test-scored
time frame: Up to 28 days
description: This is a reliable and valid 4 item scale ( arm strength, leg strength, ability to stand and step cadence),with a score range of 0-10 and is responsive to change and predictive of key outcomes.
measure: Medical Research Council Manual Muscle Test Sum Score ( MRC-ss)
time frame: Up to 28 days
description: Test of muscle strength and function, where full strength is defined as a score of 60/60 and ICU-AW as a score of <48/60
measure: Hand held dynamometry (HHD)
time frame: Up to 12 weeks
description: Assessment of hand grip strength
measure: Chelsea Critical Care Physical Assessment tool (CPAX)
time frame: Up to 28 days
description: This validated tool reliably grades physical morbidity from complete
dependence on admission though progressive independence. Scores on ICU discharge may predict recovery trajectory.
measure: ICU Mobility Scale
time frame: Up to 28 days
description: Best level of function achieved in ICU using an 11-point ordinal scale
measure: Timed up and go
time frame: Up to 6 months
description: The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
measure: Clinical Frailty Score
time frame: Up to 6 months
description: An 8 point score to classify patients as fit, vulnerable or frail and correlates with outcome in both elderly and younger patients. Pre illness frailty will be assessed by proxy on admission from information gathered from family member /NOK and from patient at the 3 follow-up assessment
measure: Barthel Index for Activities of Daily Living
time frame: Up to 6 months
description: Barthel ADL index is an ordinal scale used to measure performance in activities of daily living (ADL).
Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
measure: Six minute walk test
time frame: Up to 6 months
description: Widely used to assess functional exercise capacity in patients following an ICU admission
measure: The Hospital Anxiety and Depression Scale - HADS
time frame: 6 months
description: Measure of anxiety and depression in general medical population of patients. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
time frame: 6 months
description: A generic assessment instrument for health and disability
measure: EQ-5D-5L
time frame: 6 months
description: The descriptive system comprises self-assessment of five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
arm group label: Early mobility
arm group type: Experimental
description: Patients will receive standard physiotherapy regimen plus 2 x 30 minute rehabilitation sessions 5 days per week.
arm group label: Standard care
arm group type: No Intervention
description: Patients will receive standard physiotherapy regimen
intervention type: Other
intervention name: Early mobility
description: This progressive mobility pathway commenced with passive cycling within 48 hours of intubation and ventilation and progressing through assisted cycling, active cycling, bed exercises, sitting, mobilising out of bed to walking
arm group label: Early mobility
criteria: 
gender: All
minimum age: 42 Years
maximum age: N/A
healthy volunteers: No
last name: Rebecca Cusack, MD
role: Principal Investigator
affiliation: University Hospital Southampton NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: Yes
ipd description: Individual participant data that underlie the results manuscript will be de-identified and shared on request
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Immediately following publication. No end date.
ipd access criteria: Proposals should be addressed to EMPRESS@uhs.nhs.uk