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eStimCycle: Early Rehabilitation in Critical Care (eStimCycle)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214823
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Associate Professor Sue Berney PhD, BPT, University of Melbourne

Tracking Information
First Submitted Date  ICMJE August 7, 2014
First Posted Date  ICMJE August 12, 2014
Last Update Posted Date October 11, 2018
Actual Study Start Date  ICMJE July 2012
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2014)
  • 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 ]
    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
  • 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. ]
    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
  • Neuropsychological Battery of Tests [ Time Frame: 6 and 12 months post ICU discharge ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02214823 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2014)
  • Biomarker analyses [ Time Frame: Baseline and ICU discharge with an expected average stay of 14 days ]
    Muscle biopsy, 24 hour urine collection and blood analyses in subgroup of n=20 from main pilot randomised controlled trial.
  • Hours of mechanical ventilation, ICU hours and ICU readmission [ Time Frame: trial completion ]
    This will be collected from medical records data. This will all be reported at the completion of the trial
  • Confusion Assessment Method for ICU (CAM-ICU) [ Time Frame: Daily in ICU for an expected average of 14 days ]
    The CAM-ICU is a tool for screening for delirium in critically ill patients.
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: Hospital discharge and expected stay on average of 4 weeks ]
    A screening tool for cognitive impairment
  • Activities of Daily Living and Instrumental Activities of Daily Living [ Time Frame: Baseline, 90-day status, 6-month call ]
    Two short and simple questionnaires assessing activities of daily living.
  • 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. ]
    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).
  • Informant Questionnaire on Cognitive Decline in the Elderly, short form (IQCODE-SF) [ Time Frame: Baseline ]
    The IQCODE-SF for cognitive dysfunction will be completed at baseline by the proxy after obtaining informed consent.
  • Hospital Anxiety and Depression Scale [ Time Frame: 6 and 12 months post recruitment ]
    A scale used to detect the states of anxiety and depression
  • Impact of Events Scale - Revised (IES-R) [ Time Frame: 6 and 12 months post recruitment ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE eStimCycle: Early Rehabilitation in Critical Care
Official Title  ICMJE Functional Electrical Stimulation Assisted Cycling (eStimCycle):A Novel Intervention to Improve Outcomes in the Critically Ill
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Intensive Care Unit Acquired Weakness (ICUAW)
Intervention  ICMJE
  • Device: 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.
  • Other: Standard Care
    standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training.
Study Arms  ICMJE
  • Experimental: FES-Cycling

    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.

    Interventions:
    • Device: FES-Cycling
    • Other: Standard Care
  • Active Comparator: Standard Care

    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: Other: Standard Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2017)
162
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2014)
80
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥18 years,
  2. expected mechanical ventilation or ECMO >48 h with evidence of systemic inflammation as defined by American College of Chest Physicians (ACCP) Consensus Conference Criteria and
  3. predicted ICU length of stay ≥4 days.

Exclusion Criteria:

  1. Known primary systemic neuromuscular disease or intracranial process on ICU admission
  2. Lower limb amputation/s
  3. Unable to perform study physical outcome measures pre morbidly due to condition impairing mobility
  4. Assessed by medical staff as not-expected to survive ICU
  5. Pregnancy
  6. BMI > 40
  7. Presence of external fixator or superficial metal in lower limb
  8. Open wounds or skin abrasions at electrode application points
  9. Presence of cardiac or diaphragmatic pacemaker or implanted defibrillator with no underlying rhythm, as confirmed by the treating physician
  10. Transferred from another ICU after > 2 days of mechanical ventilation
  11. Platelets < 40 000 and INR > 1.6 (for muscle biopsy)
  12. Lower limb malignancy
  13. Pre-existing intellectual disability or cognitive impairment limiting the ability to accurately follow instructions.
  14. Non-English speaking background restricting the individuals ability to accurately and consistently follow instructions.

Exclusion criteria for the 6 and 12 month cognitive testing follow-up portion of the study:

  1. Cognitive impairment (IQCODE >3.3) done by proxy after informed consent obtained
  2. No fixed home address
  3. Score >= 10 on Alcohol use disorders and identification test (AUDIT)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02214823
Other Study ID Numbers  ICMJE ACTRN12612000528853
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Associate Professor Sue Berney PhD, BPT, University of Melbourne
Study Sponsor  ICMJE Associate Professor Sue Berney PhD, BPT
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Linda Denehy, PhD University of Melbourne
Principal Investigator: Susan Berney, PhD Austin Health
Principal Investigator: Dale Needham, PhD Johns Hopkins University
Principal Investigator: Jennifer Paratz, PhD Royal Brisbane and Women's Hospital
PRS Account University of Melbourne
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP