<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/NCT02214823</url>
  </required_header>
  <id_info>
    <org_study_id>ACTRN12612000528853</org_study_id>
    <nct_id>NCT02214823</nct_id>
  </id_info>
  <brief_title>eStimCycle: Early Rehabilitation in Critical Care</brief_title>
  <acronym>eStimCycle</acronym>
  <official_title>Functional Electrical Stimulation Assisted Cycling (eStimCycle):A Novel Intervention to Improve Outcomes in the Critically Ill</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Associate Professor Sue Berney PhD, BPT</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Melbourne</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Project Summary: Patients who have a length of stay four or more days in ICU and requiring&#xD;
      mechanical ventilation assistance to breathe for more than 48 hours will be invited to&#xD;
      participate. Participants will be randomised to either receive Functional Electrical&#xD;
      Stimulation (eStimCycle) assisted cycling or standard care. As cycling in bed has previously&#xD;
      been shown to improve physical function, patients who receive cycling as a treatment will&#xD;
      have one leg that cycles and the other leg that cycles with assistance of electrical&#xD;
      stimulation as we want to establish the effectiveness of the addition of electrical&#xD;
      stimulation of muscle. Muscle bulk, strength and physical function outcome measures will be&#xD;
      measured at baseline, weekly in ICU, ICU discharge and hospital discharge. Cognitive function&#xD;
      will also be measured at hospital discharge, 6- and 12-month follow-up. A small group of&#xD;
      patients in this study will be invited to provide samples of blood, urine and muscle at ICU&#xD;
      admission and discharge to try and determine what happens to muscle in patients who are&#xD;
      critically ill.&#xD;
&#xD;
      Significance of the Project: This is an important study because the development of&#xD;
      ICU-acquired weakness (ICU-AW) can result in long term limitations in physical function.&#xD;
      Early treatment to maintain strong muscles during an intensive care stay may help speed up&#xD;
      recovery and enhance participation in other rehabilitation treatments and improve functional&#xD;
      activities and cognition. These are important objectives for both patients and their&#xD;
      families. In addition understanding why the muscles become so weak so quickly in patients in&#xD;
      ICU will help to develop treatments that may help to maintain muscle strength.&#xD;
&#xD;
      Study Hypotheses:&#xD;
&#xD;
      Hypothesis 1: eStimCycle versus usual care rehabilitation will improve muscle strength at&#xD;
      hospital discharge.&#xD;
&#xD;
      Hypothesis 2: eStimCycle versus usual care rehabilitation will improve cognitive function at&#xD;
      6 month follow up.&#xD;
&#xD;
      Hypothesis 3: Patients receiving eStimCycle will have improved activity of anabolic&#xD;
      signalling pathways and less atrophy of skeletal muscle fibre size compared with usual care&#xD;
      rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Muscle mass and cross sectional area</measure>
    <time_frame>Baseline, weekly in ICU for an average 2 weeks and at CU discharge (on average 14 days) with participants beng followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
    <description>Bioimpedance Spectroscopy will be used to evaluate changes in muscle mass. Ultrasonography of the quadriceps will assess changes in muscle thickness and cross sectional area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>Baseline, weekly in ICU for an average 2 weeks and at ICU discharge (on average 14 dats) with participants beng followed for the duration of hospital stay on average of 4 weeks. Hand-held dynamometry will also be assessed at 6 and 12 months.</time_frame>
    <description>This will be assessed using the Medical Research Council Scale for identifying muscle weakness in ICU and also hand-held dynamometry for grip strength and isometric quadriceps strength</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropsychological Battery of Tests</measure>
    <time_frame>6 and 12 months post ICU discharge</time_frame>
    <description>Including the following tests: Hayling Sentence Completion, Weschler Adult Intelligence Scale (Digit Span and Similarities), Weschler Memory III (Logical Memory 1 and 2) and Cognistat (Judgment and Orientation), and Controlled Oral Word Association</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarker analyses</measure>
    <time_frame>Baseline and ICU discharge with an expected average stay of 14 days</time_frame>
    <description>Muscle biopsy, 24 hour urine collection and blood analyses in subgroup of n=20 from main pilot randomised controlled trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hours of mechanical ventilation, ICU hours and ICU readmission</measure>
    <time_frame>trial completion</time_frame>
    <description>This will be collected from medical records data. This will all be reported at the completion of the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confusion Assessment Method for ICU (CAM-ICU)</measure>
    <time_frame>Daily in ICU for an expected average of 14 days</time_frame>
    <description>The CAM-ICU is a tool for screening for delirium in critically ill patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>Hospital discharge and expected stay on average of 4 weeks</time_frame>
    <description>A screening tool for cognitive impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities of Daily Living and Instrumental Activities of Daily Living</measure>
    <time_frame>Baseline, 90-day status, 6-month call</time_frame>
    <description>Two short and simple questionnaires assessing activities of daily living.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical function</measure>
    <time_frame>Baseline and then weekly until ICU discharge an expected stay on average of 14 days. SPPB and 6MWT will also be measured at hospital discharge with an average length of stay of 4 weeks. 6MWT will be assessed and 6 and 12 months.</time_frame>
    <description>The physical function in ICU test (PFIT), functional status score in the ICU (FSS-ICU), short physical performance battery (SPPB) and six minute walk test (6MWT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Informant Questionnaire on Cognitive Decline in the Elderly, short form (IQCODE-SF)</measure>
    <time_frame>Baseline</time_frame>
    <description>The IQCODE-SF for cognitive dysfunction will be completed at baseline by the proxy after obtaining informed consent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>6 and 12 months post recruitment</time_frame>
    <description>A scale used to detect the states of anxiety and depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Events Scale - Revised (IES-R)</measure>
    <time_frame>6 and 12 months post recruitment</time_frame>
    <description>IES-R is an instrument to measure the subjective response to a specific traumatic event, especially in the response sets of intrusion (intrusive thoughts, nightmares, intrusive feelings and imagery, dissociative-like re-experiencing), avoidance (numbing of responsiveness, avoidance of feelings, situations, and ideas), and hyperarousal (anger, irritability, hypervigilance, difficulty concentrating, heightened startle), as well as a total subjective stress IES-R score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Intensive Care Unit Acquired Weakness (ICUAW)</condition>
  <arm_group>
    <arm_group_label>FES-Cycling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Timeframe: Within 72 hours of ICU admission. Program: Standard care physiotherapy AND up to one hour of supine cycling daily using a cycle ergometer (RT300 supine model Restorative Therapies, Ltd or Letto 300.) attached to a six channel stimulator (SAGE) and 2 additional RT50 wireless stimulator channels.&#xD;
One leg will undergo cycling alone without the electrodes turned on (sham) and the other leg will undergo cycling and muscle stimulation. Electrodes will be placed on all major lower limb muscles. Intervention will be provided individually and supervised by a physiotherapist in ICU only. Duration /Intensity: Up to 1 hour at least 5 times a week for 28 days or ICU discharge, if 20 sessions have not occurred at this time, intervention will continue until this is achieved. Intensity of muscle stimulation will be delivered at a level able to cause visible muscle contractions, confirmed by palpation.&#xD;
A subgroup of 10 individuals will be involved in biomarker analyses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Both groups will receive usual medical and nursing care in the ICU and ward. Both groups (control and intervention) will receive standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training.&#xD;
A subgroup of 10 individuals will be involved in biomarker analyses. This will involve collection of muscle biopsy, blood and urine analyses at baseline and ICU discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FES-Cycling</intervention_name>
    <arm_group_label>FES-Cycling</arm_group_label>
    <other_name>Cycle ergometer (RT300 supine model Restorative Therapies, Ltd or Letto 300.), six channel SAGE stimulator and two RT50 wireless stimulator channels.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training.</description>
    <arm_group_label>FES-Cycling</arm_group_label>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥18 years,&#xD;
&#xD;
          2. expected mechanical ventilation or ECMO &gt;48 h with evidence of systemic inflammation&#xD;
             as defined by American College of Chest Physicians (ACCP) Consensus Conference&#xD;
             Criteria and&#xD;
&#xD;
          3. predicted ICU length of stay ≥4 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known primary systemic neuromuscular disease or intracranial process on ICU admission&#xD;
&#xD;
          2. Lower limb amputation/s&#xD;
&#xD;
          3. Unable to perform study physical outcome measures pre morbidly due to condition&#xD;
             impairing mobility&#xD;
&#xD;
          4. Assessed by medical staff as not-expected to survive ICU&#xD;
&#xD;
          5. Pregnancy&#xD;
&#xD;
          6. BMI &gt; 40&#xD;
&#xD;
          7. Presence of external fixator or superficial metal in lower limb&#xD;
&#xD;
          8. Open wounds or skin abrasions at electrode application points&#xD;
&#xD;
          9. Presence of cardiac or diaphragmatic pacemaker or implanted defibrillator with no&#xD;
             underlying rhythm, as confirmed by the treating physician&#xD;
&#xD;
         10. Transferred from another ICU after &gt; 2 days of mechanical ventilation&#xD;
&#xD;
         11. Platelets &lt; 40 000 and INR &gt; 1.6 (for muscle biopsy)&#xD;
&#xD;
         12. Lower limb malignancy&#xD;
&#xD;
         13. Pre-existing intellectual disability or cognitive impairment limiting the ability to&#xD;
             accurately follow instructions.&#xD;
&#xD;
         14. Non-English speaking background restricting the individuals ability to accurately and&#xD;
             consistently follow instructions.&#xD;
&#xD;
        Exclusion criteria for the 6 and 12 month cognitive testing follow-up portion of the study:&#xD;
&#xD;
          1. Cognitive impairment (IQCODE &gt;3.3) done by proxy after informed consent obtained&#xD;
&#xD;
          2. No fixed home address&#xD;
&#xD;
          3. Score &gt;= 10 on Alcohol use disorders and identification test (AUDIT)&#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>Linda Denehy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Melbourne</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susan Berney, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Austin Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dale Needham, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Paratz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Brisbane and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Parry SM, Berney S, Koopman R, Bryant A, El-Ansary D, Puthucheary Z, Hart N, Warrillow S, Denehy L. Early rehabilitation in critical care (eRiCC): functional electrical stimulation with cycling protocol for a randomised controlled trial. BMJ Open. 2012 Sep 13;2(5):e001891. doi: 10.1136/bmjopen-2012-001891. Print 2012.</citation>
    <PMID>22983782</PMID>
  </reference>
  <reference>
    <citation>Parry SM, Berney S, Granger CL, Koopman R, El-Ansary D, Denehy L. Electrical muscle stimulation in the intensive care setting: a systematic review. Crit Care Med. 2013 Oct;41(10):2406-18. doi: 10.1097/CCM.0b013e3182923642.</citation>
    <PMID>23921276</PMID>
  </reference>
  <reference>
    <citation>Parry SM, Berney S, Warrillow S, El-Ansary D, Bryant AL, Hart N, Puthucheary Z, Koopman R, Denehy L. Functional electrical stimulation with cycling in the critically ill: a pilot case-matched control study. J Crit Care. 2014 Aug;29(4):695.e1-7. doi: 10.1016/j.jcrc.2014.03.017. Epub 2014 Mar 26.</citation>
    <PMID>24768534</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Melbourne</investigator_affiliation>
    <investigator_full_name>Associate Professor Sue Berney PhD, BPT</investigator_full_name>
    <investigator_title>Associate Professor, Head of Physiotherapy, Austin Hospital</investigator_title>
  </responsible_party>
  <pending_results>
    <submitted>April 28, 2021</submitted>
    <returned>May 20, 2021</returned>
    <submitted>June 16, 2022</submitted>
    <returned>July 12, 2022</returned>
    <submitted>July 21, 2022</submitted>
    <returned>August 18, 2022</returned>
    <submitted>September 16, 2022</submitted>
    <returned>October 13, 2022</returned>
  </pending_results>
  <!-- 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/NCT02214823
org study id: ACTRN12612000528853
nct id: NCT02214823
lead sponsor: 
has dmc: Yes
Project Summary: Patients who have a length of stay four or more days in ICU and requiring
      mechanical ventilation assistance to breathe for more than 48 hours will be invited to
      participate. Participants will be randomised to either receive Functional Electrical
      Stimulation (eStimCycle) assisted cycling or standard care. As cycling in bed has previously
      been shown to improve physical function, patients who receive cycling as a treatment will
      have one leg that cycles and the other leg that cycles with assistance of electrical
      stimulation as we want to establish the effectiveness of the addition of electrical
      stimulation of muscle. Muscle bulk, strength and physical function outcome measures will be
      measured at baseline, weekly in ICU, ICU discharge and hospital discharge. Cognitive function
      will also be measured at hospital discharge, 6- and 12-month follow-up. A small group of
      patients in this study will be invited to provide samples of blood, urine and muscle at ICU
      admission and discharge to try and determine what happens to muscle in patients who are
      critically ill.

      Significance of the Project: This is an important study because the development of
      ICU-acquired weakness (ICU-AW) can result in long term limitations in physical function.
      Early treatment to maintain strong muscles during an intensive care stay may help speed up
      recovery and enhance participation in other rehabilitation treatments and improve functional
      activities and cognition. These are important objectives for both patients and their
      families. In addition understanding why the muscles become so weak so quickly in patients in
      ICU will help to develop treatments that may help to maintain muscle strength.

      Study Hypotheses:

      Hypothesis 1: eStimCycle versus usual care rehabilitation will improve muscle strength at
      hospital discharge.

      Hypothesis 2: eStimCycle versus usual care rehabilitation will improve cognitive function at
      6 month follow up.

      Hypothesis 3: Patients receiving eStimCycle will have improved activity of anabolic
      signalling pathways and less atrophy of skeletal muscle fibre size compared with usual care
      rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Muscle mass and cross sectional area
time frame: Baseline, weekly in ICU for an average 2 weeks and at CU discharge (on average 14 days) with participants beng followed for the duration of hospital stay, an expected average of 4 weeks
description: Bioimpedance Spectroscopy will be used to evaluate changes in muscle mass. Ultrasonography of the quadriceps will assess changes in muscle thickness and cross sectional area
measure: Muscle Strength
time frame: Baseline, weekly in ICU for an average 2 weeks and at ICU discharge (on average 14 dats) with participants beng followed for the duration of hospital stay on average of 4 weeks. Hand-held dynamometry will also be assessed at 6 and 12 months.
description: This will be assessed using the Medical Research Council Scale for identifying muscle weakness in ICU and also hand-held dynamometry for grip strength and isometric quadriceps strength
measure: Neuropsychological Battery of Tests
time frame: 6 and 12 months post ICU discharge
description: Including the following tests: Hayling Sentence Completion, Weschler Adult Intelligence Scale (Digit Span and Similarities), Weschler Memory III (Logical Memory 1 and 2) and Cognistat (Judgment and Orientation), and Controlled Oral Word Association
measure: Biomarker analyses
time frame: Baseline and ICU discharge with an expected average stay of 14 days
description: Muscle biopsy, 24 hour urine collection and blood analyses in subgroup of n=20 from main pilot randomised controlled trial.
measure: Hours of mechanical ventilation, ICU hours and ICU readmission
time frame: trial completion
description: This will be collected from medical records data. This will all be reported at the completion of the trial
measure: Confusion Assessment Method for ICU (CAM-ICU)
time frame: Daily in ICU for an expected average of 14 days
description: The CAM-ICU is a tool for screening for delirium in critically ill patients.
measure: Montreal Cognitive Assessment (MoCA)
time frame: Hospital discharge and expected stay on average of 4 weeks
description: A screening tool for cognitive impairment
measure: Activities of Daily Living and Instrumental Activities of Daily Living
time frame: Baseline, 90-day status, 6-month call
description: Two short and simple questionnaires assessing activities of daily living.
measure: Physical function
time frame: Baseline and then weekly until ICU discharge an expected stay on average of 14 days. SPPB and 6MWT will also be measured at hospital discharge with an average length of stay of 4 weeks. 6MWT will be assessed and 6 and 12 months.
description: The physical function in ICU test (PFIT), functional status score in the ICU (FSS-ICU), short physical performance battery (SPPB) and six minute walk test (6MWT).
measure: Informant Questionnaire on Cognitive Decline in the Elderly, short form (IQCODE-SF)
time frame: Baseline
description: The IQCODE-SF for cognitive dysfunction will be completed at baseline by the proxy after obtaining informed consent.
measure: Hospital Anxiety and Depression Scale
time frame: 6 and 12 months post recruitment
description: A scale used to detect the states of anxiety and depression
measure: Impact of Events Scale - Revised (IES-R)
time frame: 6 and 12 months post recruitment
description: IES-R is an instrument to measure the subjective response to a specific traumatic event, especially in the response sets of intrusion (intrusive thoughts, nightmares, intrusive feelings and imagery, dissociative-like re-experiencing), avoidance (numbing of responsiveness, avoidance of feelings, situations, and ideas), and hyperarousal (anger, irritability, hypervigilance, difficulty concentrating, heightened startle), as well as a total subjective stress IES-R score.
arm group label: FES-Cycling
arm group type: Experimental
description: Timeframe: Within 72 hours of ICU admission. Program: Standard care physiotherapy AND up to one hour of supine cycling daily using a cycle ergometer (RT300 supine model Restorative Therapies, Ltd or Letto 300.) attached to a six channel stimulator (SAGE) and 2 additional RT50 wireless stimulator channels.
One leg will undergo cycling alone without the electrodes turned on (sham) and the other leg will undergo cycling and muscle stimulation. Electrodes will be placed on all major lower limb muscles. Intervention will be provided individually and supervised by a physiotherapist in ICU only. Duration /Intensity: Up to 1 hour at least 5 times a week for 28 days or ICU discharge, if 20 sessions have not occurred at this time, intervention will continue until this is achieved. Intensity of muscle stimulation will be delivered at a level able to cause visible muscle contractions, confirmed by palpation.
A subgroup of 10 individuals will be involved in biomarker analyses.
arm group label: Standard Care
arm group type: Active Comparator
description: Both groups will receive usual medical and nursing care in the ICU and ward. Both groups (control and intervention) will receive standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training.
A subgroup of 10 individuals will be involved in biomarker analyses. This will involve collection of muscle biopsy, blood and urine analyses at baseline and ICU discharge.
intervention type: Device
intervention name: FES-Cycling
arm group label: FES-Cycling
other name: Cycle ergometer (RT300 supine model Restorative Therapies, Ltd or Letto 300.), six channel SAGE stimulator and two RT50 wireless stimulator channels.
intervention type: Other
intervention name: Standard Care
description: standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training.
arm group label: FES-Cycling
arm group label: Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Linda Denehy, PhD
role: Principal Investigator
affiliation: University of Melbourne
last name: Susan Berney, PhD
role: Principal Investigator
affiliation: Austin Health
last name: Dale Needham, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Jennifer Paratz, PhD
role: Principal Investigator
affiliation: Royal Brisbane and Women's Hospital
facility: 
facility: 
facility: 
facility: 
country: Australia
country: United States
citation: Parry SM, Berney S, Koopman R, Bryant A, El-Ansary D, Puthucheary Z, Hart N, Warrillow S, Denehy L. Early rehabilitation in critical care (eRiCC): functional electrical stimulation with cycling protocol for a randomised controlled trial. BMJ Open. 2012 Sep 13;2(5):e001891. doi: 10.1136/bmjopen-2012-001891. Print 2012.
PMID: 22983782
citation: Parry SM, Berney S, Granger CL, Koopman R, El-Ansary D, Denehy L. Electrical muscle stimulation in the intensive care setting: a systematic review. Crit Care Med. 2013 Oct;41(10):2406-18. doi: 10.1097/CCM.0b013e3182923642.
PMID: 23921276
citation: Parry SM, Berney S, Warrillow S, El-Ansary D, Bryant AL, Hart N, Puthucheary Z, Koopman R, Denehy L. Functional electrical stimulation with cycling in the critically ill: a pilot case-matched control study. J Crit Care. 2014 Aug;29(4):695.e1-7. doi: 10.1016/j.jcrc.2014.03.017. Epub 2014 Mar 26.
PMID: 24768534
responsible party type: Sponsor-Investigator
investigator affiliation: University of Melbourne
investigator full name: Associate Professor Sue Berney PhD, BPT
investigator title: Associate Professor, Head of Physiotherapy, Austin Hospital
submitted: April 28, 2021
returned: May 20, 2021
submitted: June 16, 2022
returned: July 12, 2022
submitted: July 21, 2022
returned: August 18, 2022
submitted: September 16, 2022
returned: October 13, 2022