<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/NCT01707303</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00000240</org_study_id>
    <nct_id>NCT01707303</nct_id>
  </id_info>
  <brief_title>Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure</brief_title>
  <official_title>Effect Of Acute Inflammatory Mediators On Duration Of Functional Limitations In Patients With Acute Respiratory Failure, A Randomized, Controlled Pilot Study of Early ICU Rehabilitation Strategies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</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>
      This is a randomized, controlled, pilot study of two separate Cohorts of patients from the&#xD;
      intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical&#xD;
      therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50&#xD;
      patients and randomize to receive either two physical therapy sessions per day or usual care.&#xD;
      Outcome will be length of hospital stay measured in days. Secondary outcomes will be&#xD;
      mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength&#xD;
      assessments and the short physical performance battery (SPPB). Study subjects will have blood&#xD;
      for cytokine analysis through their first week of study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2007</start_date>
  <completion_date type="Actual">August 2009</completion_date>
  <primary_completion_date type="Actual">July 2009</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>Hospital length of stay, days</measure>
    <time_frame>The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.</time_frame>
    <description>Hospital stay measured in days.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual hospital rehabilitative services</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early ICU Rehabilitation Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Early ICU physical therapy will be applied in this arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early ICU rehabilitation strategies</intervention_name>
    <description>Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II</description>
    <arm_group_label>Early ICU Rehabilitation Strategy</arm_group_label>
    <other_name>Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>All typically applied hospital rehabilitative services applied in the usual fashion</description>
    <arm_group_label>Usual Care</arm_group_label>
    <other_name>Usual Hospital Rehabilitative Services</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Mechanically ventilated via an endotracheal tube or mask&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to walk without assistance prior to acute ICU illness (use of a cane or&#xD;
             walkers not exclusions)&#xD;
&#xD;
          -  Cognitive impairment prior to acute ICU illness (non-verbal)&#xD;
&#xD;
          -  Preadmit immunocompromised (&gt;prednisone 20 mg/d for 2 wks)&#xD;
&#xD;
          -  Acute stroke&#xD;
&#xD;
          -  Body mass index (BMI) &gt;45&#xD;
&#xD;
          -  Neuromuscular disease that could impair weaning (myasthenia gravis, ALS,&#xD;
             Guillain-Barre)&#xD;
&#xD;
          -  Hip fracture, unstable cervical spine or pathological fracture&#xD;
&#xD;
          -  Mech vent &gt;48 hours prior to transfer from an outside facility&#xD;
&#xD;
          -  Current hospitalization or transferring hospital stay &gt;72 hours&#xD;
&#xD;
          -  CPR on admission, DNR on admission&#xD;
&#xD;
          -  Hospitalization within 30 days prior to admission&#xD;
&#xD;
          -  Cancer therapy within last 6 months&#xD;
&#xD;
          -  Re-admission to ICU within current hospitalization&#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_official>
    <last_name>Peter E. Morris, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest School of Medicine</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>August 13, 2018</last_update_submitted>
  <last_update_submitted_qc>August 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ICU</keyword>
  <keyword>Critical Care</keyword>
  <keyword>Intensive Care</keyword>
  <keyword>Critical Illness</keyword>
  <keyword>Acute Respiratory Failure</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Physical Therapy</keyword>
  <keyword>Strength</keyword>
  <keyword>Functional Status</keyword>
  <keyword>Short Physical Performance Battery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</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/NCT01707303
org study id: IRB00000240
nct id: NCT01707303
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized, controlled, pilot study of two separate Cohorts of patients from the
      intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical
      therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50
      patients and randomize to receive either two physical therapy sessions per day or usual care.
      Outcome will be length of hospital stay measured in days. Secondary outcomes will be
      mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength
      assessments and the short physical performance battery (SPPB). Study subjects will have blood
      for cytokine analysis through their first week of study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Hospital length of stay, days
time frame: The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.
description: Hospital stay measured in days.
arm group label: Usual Care
arm group type: Other
description: Usual hospital rehabilitative services
arm group label: Early ICU Rehabilitation Strategy
arm group type: Experimental
description: Early ICU physical therapy will be applied in this arm
intervention type: Other
intervention name: Early ICU rehabilitation strategies
description: Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II
arm group label: Early ICU Rehabilitation Strategy
other name: Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.
intervention type: Other
intervention name: Usual Care
description: All typically applied hospital rehabilitative services applied in the usual fashion
arm group label: Usual Care
other name: Usual Hospital Rehabilitative Services
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter E. Morris, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Respiratory Distress Syndrome
sharing ipd: No