<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/NCT02976415</url>
  </required_header>
  <id_info>
    <org_study_id>2016-1999-GRA</org_study_id>
    <nct_id>NCT02976415</nct_id>
  </id_info>
  <brief_title>In-Bed Cycling in ICU Patients Post Cardiac Surgery</brief_title>
  <acronym>CardiO Cycle</acronym>
  <official_title>CardiO Cycle: A Pilot Safety and Feasibility Study of In-Bed Cycling in Patients Post Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamilton Health Sciences Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hamilton Health Sciences Corporation</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 purpose of this study is to determine if in-bed cycling is safe and feasible in&#xD;
      critically-ill patients after open heart surgery. The investigators hypothesize that in-bed&#xD;
      cycling can be safely used with this population and that it is feasible to use in a&#xD;
      fast-paced cardiac intensive care unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Advances in medical science and technologies have lead to more effective&#xD;
      management of critically-ill patients with a subsequent improvement in ICU survival rates.&#xD;
      Patients who survive their ICU stay are often left with post-ICU impairments including muscle&#xD;
      weakness and functional limitations. Cardiac surgeries are commonly performed worldwide with&#xD;
      the majority of patients requiring post-operative ICU care. In the past decade, patients who&#xD;
      qualify for cardiac surgery tend to be older, have a great number of co-morbidities and are&#xD;
      more likely to require a prolonged ICU stay. The effectiveness of physiotherapy and various&#xD;
      rehabilitation modalities in patients both pre- and post cardiac surgery has been&#xD;
      investigated. However, to date no study specifically addresses the feasibility and safety of&#xD;
      in-bed cycling in patients undergoing cardiac surgery who require prolonged critical care.&#xD;
&#xD;
      Principle Research Question: Is in-bed cycling a safe and feasible intervention in patients&#xD;
      post cardiac surgery that require a prolonged stay in critical care?&#xD;
&#xD;
      Methods: Adult patients post-cardiac surgery admitted to the cardiac surgery ICU who will&#xD;
      remain intubated and ventilated for at least 72 hours will be eligible for enrollment.&#xD;
      Participants will receive 20 minutes of in-bed cycling plus routine physiotherapy performed&#xD;
      by critical care physiotherapists. Patients will be enrolled for 28 days or until they are&#xD;
      able to ambulate.&#xD;
&#xD;
      Primary Outcomes: Safety of bedside cycling will be evaluated by monitoring the number of&#xD;
      adverse events that occur during each cycling session. Feasibility of implementing in-bed&#xD;
      cycling into daily physiotherapy practice will be evaluated by determining if cycling&#xD;
      sessions can be conducted at least eighty percent of the time that cycling is appropriate.&#xD;
&#xD;
      Relevance: Before conducting a larger randomized controlled trial investigating the&#xD;
      effectiveness of in-bed cycling in the critically-ill cardiac surgery population, the safety&#xD;
      of this intervention needs to be determined. This will be the first study in a program of&#xD;
      research evaluating bedside cycling in the cardiac surgical ICU.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">March 29, 2019</completion_date>
  <primary_completion_date type="Actual">March 29, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of safety events that occur during cycling sessions</measure>
    <time_frame>From date of study enrollment until the date of study completion, up to 28 days maximum</time_frame>
    <description>Potential safety events include:&#xD;
Hypertension (systolic blood pressure greater than 160 mmHg)&#xD;
Hypotension (systolic blood pressure less than 90 mmHg)&#xD;
Oxygen desaturation to less than 85% for more than two minutes&#xD;
Cardiorespiratory arrest&#xD;
Removal of any lines or tubes (chest tubes, pulmonary artery catheter, nasal-gastric tube, Jackson-Pratt drains, central venous catheter, endotracheal tube, tracheostomy decannulation)&#xD;
New onset cardiac arrhythmias (atrial fibrillation, bigeminy, trigeminy, junctional, heart block rhythms)&#xD;
Saphenous vein graft dehiscence&#xD;
New onset agitation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of completing 80% of eligible cycling sessions</measure>
    <time_frame>From date of study enrollment to the date of study completion, up to 28 days maximum</time_frame>
    <description>The feasibility of implementing in-bed cycling into daily physiotherapy practice will be evaluated by determining if cycling sessions can be conducted at least 80% of the time that cycling is appropriate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Completing Hand Grip Strength at ICU Awakening and ICU Discharge</measure>
    <time_frame>When patient awake (unspecified time, patient dependent), at completion of study involvement (maximum: day 28 of ICU)</time_frame>
    <description>Hand grip strength will be assessed using a hand-held JAMAR dynamometer. Patients will be seated with elbow bent to 90 degrees. Patients will be asked to &quot;squeeze the handle as hard as possible&quot; and the maximum score will be taken after five seconds. Average of three trials will be documented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Two Minute Walk Test</measure>
    <time_frame>At ICU Awakening (an estimated 8 days after study enrollment) and at the completion of the study (maximum: day 28 of ICU)</time_frame>
    <description>In an unobstructed area, patients will be instructed to walk back and forth covering as much distance as possible in two minutes. Gait aids may be used and patients are permitted to rest as needed during the test. No encouragement will be provided during the two minute test. The number of rest stops, the duration of the rests and the distance traveled in meters will be documented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Status Score for the ICU (FSS-ICU)</measure>
    <time_frame>Assessed daily, up to a maximum of 28 days</time_frame>
    <description>The FSS-ICU is a five-item functional measure that evaluates the ability of each client to perform five specific tasks (rolling, supine to sit, sitting at edge of bed, sit to stand, walking). Each scale is assessed using an 8-point ordinal scale (0 - inability to perform the task to 7 - able to perform the task independently)</description>
  </secondary_outcome>
  <enrollment type="Actual">23</enrollment>
  <condition>Cardiac Disease</condition>
  <condition>Critical Illness</condition>
  <condition>Critical Illness Polyneuropathy</condition>
  <condition>Critical Illness Myopathy</condition>
  <condition>Thoracic Surgery</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>In-Bed Cycling</intervention_name>
    <description>20 minutes of in-bed cycling, either active, passive or a combination of active and passive.</description>
    <other_name>Bedside Cycling</other_name>
    <other_name>Bedside Ergometry</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female adults patients aged 18 years and greater&#xD;
&#xD;
          -  History of cardiac surgery in the past seven days&#xD;
&#xD;
          -  Admitted to the cardiac surgery ICU for greater than 3 days but less than 7 days&#xD;
&#xD;
          -  Mechanically ventilated for at least 72 hours and expected to remain ventilated for at&#xD;
             least two more days&#xD;
&#xD;
          -  Able to ambulate independently, with or without a gait aid, prior to hospital&#xD;
             admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncomplicated post-operative course with expected discharge to ward within 24 to 72&#xD;
             hours&#xD;
&#xD;
          -  Previous lower extremity amputation&#xD;
&#xD;
          -  Open or unstable saphenous vein graft sites&#xD;
&#xD;
          -  Inability to understand English&#xD;
&#xD;
          -  Body size and/or weight that is incompatible with the bedside ergometer&#xD;
&#xD;
          -  Patients who are not expected to survive their ICU stay&#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>Anastasia N Newman, PhD Student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamilton Health Sciences Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamilton General Hosptial</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hamilton Health Sciences Corporation</investigator_affiliation>
    <investigator_full_name>Anastasia Newman</investigator_full_name>
    <investigator_title>Physiotherapist, PhD Student</investigator_title>
  </responsible_party>
  <keyword>Cardiac Surgery</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>In-Bed Cycling</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Cycle Ergometry</keyword>
  <keyword>Early Mobilization</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Critical Care</keyword>
  <keyword>Intensive Care Unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyneuropathies</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <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/NCT02976415
org study id: 2016-1999-GRA
nct id: NCT02976415
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if in-bed cycling is safe and feasible in
      critically-ill patients after open heart surgery. The investigators hypothesize that in-bed
      cycling can be safely used with this population and that it is feasible to use in a
      fast-paced cardiac intensive care unit.
Background: Advances in medical science and technologies have lead to more effective
      management of critically-ill patients with a subsequent improvement in ICU survival rates.
      Patients who survive their ICU stay are often left with post-ICU impairments including muscle
      weakness and functional limitations. Cardiac surgeries are commonly performed worldwide with
      the majority of patients requiring post-operative ICU care. In the past decade, patients who
      qualify for cardiac surgery tend to be older, have a great number of co-morbidities and are
      more likely to require a prolonged ICU stay. The effectiveness of physiotherapy and various
      rehabilitation modalities in patients both pre- and post cardiac surgery has been
      investigated. However, to date no study specifically addresses the feasibility and safety of
      in-bed cycling in patients undergoing cardiac surgery who require prolonged critical care.

      Principle Research Question: Is in-bed cycling a safe and feasible intervention in patients
      post cardiac surgery that require a prolonged stay in critical care?

      Methods: Adult patients post-cardiac surgery admitted to the cardiac surgery ICU who will
      remain intubated and ventilated for at least 72 hours will be eligible for enrollment.
      Participants will receive 20 minutes of in-bed cycling plus routine physiotherapy performed
      by critical care physiotherapists. Patients will be enrolled for 28 days or until they are
      able to ambulate.

      Primary Outcomes: Safety of bedside cycling will be evaluated by monitoring the number of
      adverse events that occur during each cycling session. Feasibility of implementing in-bed
      cycling into daily physiotherapy practice will be evaluated by determining if cycling
      sessions can be conducted at least eighty percent of the time that cycling is appropriate.

      Relevance: Before conducting a larger randomized controlled trial investigating the
      effectiveness of in-bed cycling in the critically-ill cardiac surgery population, the safety
      of this intervention needs to be determined. This will be the first study in a program of
      research evaluating bedside cycling in the cardiac surgical ICU.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of safety events that occur during cycling sessions
time frame: From date of study enrollment until the date of study completion, up to 28 days maximum
description: Potential safety events include:
Hypertension (systolic blood pressure greater than 160 mmHg)
Hypotension (systolic blood pressure less than 90 mmHg)
Oxygen desaturation to less than 85% for more than two minutes
Cardiorespiratory arrest
Removal of any lines or tubes (chest tubes, pulmonary artery catheter, nasal-gastric tube, Jackson-Pratt drains, central venous catheter, endotracheal tube, tracheostomy decannulation)
New onset cardiac arrhythmias (atrial fibrillation, bigeminy, trigeminy, junctional, heart block rhythms)
Saphenous vein graft dehiscence
New onset agitation
measure: Feasibility of completing 80% of eligible cycling sessions
time frame: From date of study enrollment to the date of study completion, up to 28 days maximum
description: The feasibility of implementing in-bed cycling into daily physiotherapy practice will be evaluated by determining if cycling sessions can be conducted at least 80% of the time that cycling is appropriate.
measure: Feasibility of Completing Hand Grip Strength at ICU Awakening and ICU Discharge
time frame: When patient awake (unspecified time, patient dependent), at completion of study involvement (maximum: day 28 of ICU)
description: Hand grip strength will be assessed using a hand-held JAMAR dynamometer. Patients will be seated with elbow bent to 90 degrees. Patients will be asked to "squeeze the handle as hard as possible" and the maximum score will be taken after five seconds. Average of three trials will be documented.
measure: Two Minute Walk Test
time frame: At ICU Awakening (an estimated 8 days after study enrollment) and at the completion of the study (maximum: day 28 of ICU)
description: In an unobstructed area, patients will be instructed to walk back and forth covering as much distance as possible in two minutes. Gait aids may be used and patients are permitted to rest as needed during the test. No encouragement will be provided during the two minute test. The number of rest stops, the duration of the rests and the distance traveled in meters will be documented.
measure: Functional Status Score for the ICU (FSS-ICU)
time frame: Assessed daily, up to a maximum of 28 days
description: The FSS-ICU is a five-item functional measure that evaluates the ability of each client to perform five specific tasks (rolling, supine to sit, sitting at edge of bed, sit to stand, walking). Each scale is assessed using an 8-point ordinal scale (0 - inability to perform the task to 7 - able to perform the task independently)
intervention type: Other
intervention name: In-Bed Cycling
description: 20 minutes of in-bed cycling, either active, passive or a combination of active and passive.
other name: Bedside Cycling
other name: Bedside Ergometry
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anastasia N Newman, PhD Student
role: Principal Investigator
affiliation: Hamilton Health Sciences Corporation
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Hamilton Health Sciences Corporation
investigator full name: Anastasia Newman
investigator title: Physiotherapist, PhD Student
mesh term: Polyneuropathies
mesh term: Heart Diseases
mesh term: Critical Illness
sharing ipd: No