Extracorporeal Membrane Oxygenation Physical Training
Condition: Critically Ill, Mechanically Ventilated; Extracorporeal Membrane Oxygenation Complication
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Critically ill patients who require extracorporeal membrane oxygenation (ECMO) are the
      sickest in the hospital. More patients are surviving but survivors have compromised
      functional recovery for months or years. This trial aims to determine if early, physical
      training commenced within 48 hours of ECMO is feasible and improves muscle strength and
      functional status in patients compared to standard practice in a randomised controlled trial
      of 30 ICU patients.
    

Detailed description: 
      The use of extracorporeal membrane oxygenation (ECMO) has expanded dramatically in Australia
      and globally. While life-saving in the short-term, it is typically associated with prolonged
      immobility and inflammation, which contributes to severe muscle weakness and wasting.
      Standard care delivers minimal physical training while patients remain on ECMO because
      standard care prioritises concerns about catheter dislodgement and cardio-respiratory strain.
      However, in other intensive care unit (ICU) conditions, techniques have been developed to
      allow early physical training in patients previously thought too unstable to be exercised,
      with important patient-centred and long-term cost-saving benefits. Our preliminary work shows
      that early individualised physical training is safe in ICU patients. A multicentre pilot
      study to establish feasibility in ECMO patients is urgently needed.

      The primary aim is to test the hypothesis that early, individualised, physical training
      (commenced within first 48 hours of ECMO) is feasible and improves functional recovery (the
      highest level of activity and duration). This has previously been reported to be associated
      with improved independent function at hospital discharge and discharge to home.1 The
      secondary aims are to test the hypothesis that early individualised physical training is (i)
      safe; (ii) improves muscle strength at day 7 and 10 and 20; and (iii) improves functional
      status (IMS) at day 7, 10 and 20 in ECMO patients relative to standard care.

      We are also aiming to describe the acute physiological effects of early physical training
      (commenced within 48hours of ECMO initiation) Respiratory and haemodynamic parameters, along
      with ECMO settings, will be recorded 30 minutes prior to each physical training session,
      during the session and 30 minutes post the training session. In addition, the range of values
      (min to max) for these parameters will be recorded for each 24hour period over the 7 days.
    

Intervention name(s): Early activity and Mobilisation intervention
Intervention type(s): Behavioral
Intervention description(s): The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A 30 patient, multicentre, randomised, trial of early individualised physical training compared to standard care.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment