eRiCC trial: Early rehabilitation in Critical Care
Functional electrical stimulation assisted cycling to prevent muscle weakness in intensive care: pilot randomised controlled trial
Selina Parry
80 participants
May 30, 2012
Interventional
Conditions
Summary
Intensive care acquired weakness is a common problem following an ICU admission and leads to significant impairment in physical function and strength which is most prevalent in individuals affected with sepsis. Muscle mass reductions occur rapidly with up to 20% lost within the first week alone, this is accelerated in sepsis with greater muscle protein degradation. Whilst early rehabilitation commonly involving mobilisation has been shown to be both feasible and safe, it often is delayed in commencement as it relies on the individual being alert and able to participate in therapy. This trial involves the use of an intervention which can commence early in the ICU admission to try to minimise the muscle changes that occur without the direct need for patient participation and engagement. This trial will examine the effectiveness of functional electrical stimulation assisted cycling using a supine cycling machine and cycling alone compared to standard care in individuals with sepsis within the intensive care unit. Within a subgroup of 20 individuals biomarker analyses will be performed to try to understand the cellular and molecular mechanisms responsible for the changes observed.
Eligibility
Inclusion Criteria1
- Individuals expected to be mechanically ventilated for > 48 hours with diagnosis of sepsis or severe sepsis as defined by ACCP Consensus Conference criteria and predicted to remain in ICU for 4 days or more.
Exclusion Criteria12
- Patients will be excluded if:
- Known primary systemic neuromuscular disease or intracranial process on ICU admission
- Lower limb amputation/s
- Unable to perform study physical outcome measures pre morbidly due to condition impairing mobility
- assessed by medical staff as approaching imminent death or withdrawal of medical treatment within 36 hours
- Pregnancy
- BMI > 40
- Presence of external fixator or superficial metal in lower limb
- open wounds or skin abrasions at electrode application points
- presence of pacemaker or implanted defibrillator
- transferred from another ICU after > 2 days of mechanical ventilation
- platelets < 40 000 and INR > 1.6 (for muscle biopsy)
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Interventions
Intervention Arm: Timeframe: Within 72 hours of ICU admission until ICU discharge Program: In addition to standard care physiotherapy, individuals within the intervention arm of the trial will undergo up to one hour of supine cycling daily with the aim of training at least five times per week using a cycle ergometer (RT300 supine model Restorative Therapies, Ltd., Baltimore, United States) attached to a six channel stimulator (SAGE stimulator, Restorative Therapies Ltd., Baltimore, United States) and two additional RT50 wireless stimulator channels. Within the intervention arm it is a single legged design with one leg undergoing cycling alone without the electrodes turned on (sham) and the other leg undergoing cycling and muscle stimulation. Electrodes will be placed on all the major lower limb muscles. The intervention will be provided on an individual basis and supervised by a trained physiotherapist. Duration and Intensity: Up to 1 hour aiming for at least 5 times a week. The intensity of muscle stimulation will be delivered at a level able to cause visible muscle contractions in all muscle groups and will be confirmed by palpation.
Locations(1)
View Full Details on ANZCTR
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ACTRN12612000528853