<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/NCT03806257</url>
  </required_header>
  <id_info>
    <org_study_id>STU 012018-090</org_study_id>
    <nct_id>NCT03806257</nct_id>
  </id_info>
  <brief_title>Patient Mobility and Outcomes After Cardiac Surgery</brief_title>
  <official_title>Patient Mobility and Outcomes After Cardiac Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</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>
      Standards for post-cardiac surgery physical interventions vary between insitutions and there&#xD;
      are no published guidelines for national organizations in the U.S. The increasing body of&#xD;
      evidence for the effectiveness of physical interventions coupled with variability in how&#xD;
      these interventions are implemented suggests a critical need to prospectively determine the&#xD;
      impact of clearly defined postoperative physical interventions. This randomized, controlled&#xD;
      study seeks to determine the effectiveness of a three-pronged, enhanced, post-operative&#xD;
      physical therapy protocol which includes 1) early mobilization, 2) frequent mobilization and&#xD;
      ambulation, and 3) patient education on the outcomes of hospital lengths of stay and&#xD;
      discharge disposition. The investigators will enroll 220 adult subjects undergoing elective&#xD;
      CABG, mitral valve repair or replacement surgery, aortic valve surgery, or combined&#xD;
      CABG/valve procedures. Subjects will be randomized to either the control (standard-of-care)&#xD;
      group or intervention group (enhanced protocol), and followed for five days. Subjects in each&#xD;
      group will wear a FitBit Charge 2 for the duration of the five days following surgery. This&#xD;
      will provide both sleep activity and steps data that will be analyzed for sleep quality and&#xD;
      distance walked. The primary aim is to assess the difference between groups for ICU and&#xD;
      hospital length of stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be identified based on pre-screening the cardiothoracic surgery schedule. Study&#xD;
      staff will visit potential study subjects in the pre-surgical testing clinic to discuss the&#xD;
      study's objectives and to ascertain subjects' interest in participating in the study. After&#xD;
      providing informed consent, subjects will be randomized using SAS into either the&#xD;
      interventional group or standard care group after their surgical procedure is complete and&#xD;
      the subject has been transferred to the CVICU. After completion of the surgical procedure,&#xD;
      patients who had a major perioperative complication such as stroke, myocardial infarction,&#xD;
      pulmonary embolism, hemorrhage requiring massive transfusion (&gt;10 units of PRBCs),&#xD;
      intraoperative cardiac arrest, or intraoperative pulmonary arrest, will be considered screen&#xD;
      failures and will not be randomized, since the investigators consider the patient enrolled&#xD;
      once randomized. Patients randomized to the interventional group will undergo the enhanced&#xD;
      physical therapy protocol which includes mobilization from bed to chair on the day of surgery&#xD;
      and more frequent ambulation on the subsequent five days.&#xD;
&#xD;
      The main differences between the standard therapy (control) group and intervention group is&#xD;
      the timing of post-operative mobilization and ambulation, as well as the point at which they&#xD;
      receive gait and safe ambulation training. In the standard therapy group, the patients will&#xD;
      receive a FitBit2 after their arrival on the ICU, withstanding any postoperative&#xD;
      complications. On POD 1 the subjects routinely get up to the bedside chair with the help of&#xD;
      an ICU nurse or physical therapist. The subjects will generally ambulate one-half the&#xD;
      circumference of the ICU with assistance, though this is not enforced. On POD2 and onward,&#xD;
      the standard therapy group typically will get up to the bedside chair at least once, as well&#xD;
      as walk one-half circumference of the ICU, and will receive the standard physical therapy&#xD;
      gait and ambulation training. The intervention group will have the FitBit2 watch placed on&#xD;
      their wrist on POD 0, along with getting up to the bedside chair. On POD 1, the subjects will&#xD;
      get up to the bedside chair twice (as tolerated by patient), and will be asked to walk&#xD;
      one-half the ICU circumference. Additionally, the patient's physical therapy and&#xD;
      gait/ambulation training will commence on POD 1. On POD 2, the subjects will get up to the&#xD;
      bedside chair three times, and will be asked to attempt three walks with the goal of one full&#xD;
      ICU circumference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">March 28, 2018</start_date>
  <completion_date type="Anticipated">July 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 28, 2023</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>Randomized controlled prospective design involving two study groups: 1) standard-of-care for cardiac physical therapy, and 2) enhanced protocol for cardiac physical therapy. Primary aim is to assess difference, if any, between groups for ICU and hospital length of stay.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shorter ICU Length of Stay</measure>
    <time_frame>1.2 days</time_frame>
    <description>Decrease days in ICU from average standard-of-care patient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shorter Hospital Length of Stay</measure>
    <time_frame>2 days</time_frame>
    <description>Decrease days in hospital from average standard-of-care patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite Clinical Outcome</measure>
    <time_frame>5 days</time_frame>
    <description>Combined incidence of pulmonary atelectasis, pneumonia, venous thromboembolism, pulmonary embolism, and mortality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longer sleep duration with fewer awakenings</measure>
    <time_frame>8 hours sleep, less than 3 awakenings</time_frame>
    <description>Sleep time that is longer than average standard-of-care patient</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Cardiac Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in the control arm will receive standard of care, which consists of mobilization to a bedside chair at least once, and ambulate one-half ICU circumference on postoperative day one. On postoperative days two through five, the subject will be mobilized to the bedside chair at least once, and ambulated at least once with target of one full ICU circumference. These subjects will receive gait training and safe ambulation education, and wear a FitBit Charge 2 watch for five days after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Physical Therapy Protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the experimental arm will recieve a FitBit Charge 2 watch, and will be mobilized to the bedside chair on postoperative day zero. On postoperative day two subjects will be mobilized to the bedside chair twice, ambulate one-half of the ICU circumference, and receive gait and safe ambulation training. On postoperative days two through five, subjects will mobilize to the bedside chair three times, and will be encouraged to ambulate three times, each time with a target of one full ICU circumference.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Physical Therapy Protocol</intervention_name>
    <description>A structured physical therapy protocol that requires subject to ambulate more frequently than the standard-of-care patient.</description>
    <arm_group_label>Enhanced Physical Therapy Protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years or older undergoing scheduled, elective coronary artery bypass graft&#xD;
             (CABG) surgery, mitral valve repair or replacement surgery, aortic valve repair or&#xD;
             replacement surgery and combined CABG with one or more valve repair or replacement&#xD;
             surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who do not med the inclusion criteria&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Those patients with skin or systemic infections&#xD;
&#xD;
          -  Those patients who are paraplegic or quadriplegic&#xD;
&#xD;
          -  Those patients who have allergies to polyurethane&#xD;
&#xD;
          -  Any patient who experiences perioperative complications (e.g., stroke, myocardial&#xD;
             infarction, pulmonary embolism, hemorrhage requiring massive transfusion (&gt;10 units of&#xD;
             PRBCs), intraoperative cardiac arrest, or intraoperative pulmonary arrest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Sreekanth Cheruku</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will not share data with any outside entity or non-IRB-approved personnel.</ipd_description>
  </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/NCT03806257
org study id: STU 012018-090
nct id: NCT03806257
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Standards for post-cardiac surgery physical interventions vary between insitutions and there
      are no published guidelines for national organizations in the U.S. The increasing body of
      evidence for the effectiveness of physical interventions coupled with variability in how
      these interventions are implemented suggests a critical need to prospectively determine the
      impact of clearly defined postoperative physical interventions. This randomized, controlled
      study seeks to determine the effectiveness of a three-pronged, enhanced, post-operative
      physical therapy protocol which includes 1) early mobilization, 2) frequent mobilization and
      ambulation, and 3) patient education on the outcomes of hospital lengths of stay and
      discharge disposition. The investigators will enroll 220 adult subjects undergoing elective
      CABG, mitral valve repair or replacement surgery, aortic valve surgery, or combined
      CABG/valve procedures. Subjects will be randomized to either the control (standard-of-care)
      group or intervention group (enhanced protocol), and followed for five days. Subjects in each
      group will wear a FitBit Charge 2 for the duration of the five days following surgery. This
      will provide both sleep activity and steps data that will be analyzed for sleep quality and
      distance walked. The primary aim is to assess the difference between groups for ICU and
      hospital length of stay.
Patients will be identified based on pre-screening the cardiothoracic surgery schedule. Study
      staff will visit potential study subjects in the pre-surgical testing clinic to discuss the
      study's objectives and to ascertain subjects' interest in participating in the study. After
      providing informed consent, subjects will be randomized using SAS into either the
      interventional group or standard care group after their surgical procedure is complete and
      the subject has been transferred to the CVICU. After completion of the surgical procedure,
      patients who had a major perioperative complication such as stroke, myocardial infarction,
      pulmonary embolism, hemorrhage requiring massive transfusion (>10 units of PRBCs),
      intraoperative cardiac arrest, or intraoperative pulmonary arrest, will be considered screen
      failures and will not be randomized, since the investigators consider the patient enrolled
      once randomized. Patients randomized to the interventional group will undergo the enhanced
      physical therapy protocol which includes mobilization from bed to chair on the day of surgery
      and more frequent ambulation on the subsequent five days.

      The main differences between the standard therapy (control) group and intervention group is
      the timing of post-operative mobilization and ambulation, as well as the point at which they
      receive gait and safe ambulation training. In the standard therapy group, the patients will
      receive a FitBit2 after their arrival on the ICU, withstanding any postoperative
      complications. On POD 1 the subjects routinely get up to the bedside chair with the help of
      an ICU nurse or physical therapist. The subjects will generally ambulate one-half the
      circumference of the ICU with assistance, though this is not enforced. On POD2 and onward,
      the standard therapy group typically will get up to the bedside chair at least once, as well
      as walk one-half circumference of the ICU, and will receive the standard physical therapy
      gait and ambulation training. The intervention group will have the FitBit2 watch placed on
      their wrist on POD 0, along with getting up to the bedside chair. On POD 1, the subjects will
      get up to the bedside chair twice (as tolerated by patient), and will be asked to walk
      one-half the ICU circumference. Additionally, the patient's physical therapy and
      gait/ambulation training will commence on POD 1. On POD 2, the subjects will get up to the
      bedside chair three times, and will be asked to attempt three walks with the goal of one full
      ICU circumference.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled prospective design involving two study groups: 1) standard-of-care for cardiac physical therapy, and 2) enhanced protocol for cardiac physical therapy. Primary aim is to assess difference, if any, between groups for ICU and hospital length of stay.
primary purpose: Treatment
masking: None (Open Label)
measure: Shorter ICU Length of Stay
time frame: 1.2 days
description: Decrease days in ICU from average standard-of-care patient
measure: Shorter Hospital Length of Stay
time frame: 2 days
description: Decrease days in hospital from average standard-of-care patient
measure: Composite Clinical Outcome
time frame: 5 days
description: Combined incidence of pulmonary atelectasis, pneumonia, venous thromboembolism, pulmonary embolism, and mortality.
measure: Longer sleep duration with fewer awakenings
time frame: 8 hours sleep, less than 3 awakenings
description: Sleep time that is longer than average standard-of-care patient
arm group label: Control
arm group type: No Intervention
description: Subjects in the control arm will receive standard of care, which consists of mobilization to a bedside chair at least once, and ambulate one-half ICU circumference on postoperative day one. On postoperative days two through five, the subject will be mobilized to the bedside chair at least once, and ambulated at least once with target of one full ICU circumference. These subjects will receive gait training and safe ambulation education, and wear a FitBit Charge 2 watch for five days after surgery.
arm group label: Enhanced Physical Therapy Protocol
arm group type: Experimental
description: Subjects in the experimental arm will recieve a FitBit Charge 2 watch, and will be mobilized to the bedside chair on postoperative day zero. On postoperative day two subjects will be mobilized to the bedside chair twice, ambulate one-half of the ICU circumference, and receive gait and safe ambulation training. On postoperative days two through five, subjects will mobilize to the bedside chair three times, and will be encouraged to ambulate three times, each time with a target of one full ICU circumference.
intervention type: Other
intervention name: Enhanced Physical Therapy Protocol
description: A structured physical therapy protocol that requires subject to ambulate more frequently than the standard-of-care patient.
arm group label: Enhanced Physical Therapy Protocol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Sreekanth Cheruku
investigator title: Assistant Professor
sharing ipd: No
ipd description: We will not share data with any outside entity or non-IRB-approved personnel.