RecruitingACTRN12612000528853

eRiCC trial: Early rehabilitation in Critical Care

Functional electrical stimulation assisted cycling to prevent muscle weakness in intensive care: pilot randomised controlled trial

Sponsor

Selina Parry

Enrollment

80 participants

Start Date

May 30, 2012

Study Type

Interventional

Conditions

Sepsis Intensive care Unit acquired weakness

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether starting a special cycling exercise program early — even while a person is still in the intensive care unit on a breathing machine — can prevent the severe muscle weakness that often happens after a serious infection (sepsis) in the ICU. The program uses electrical stimulation to make the leg muscles contract and cycle on a specially designed machine, even when the patient cannot do it themselves. A comparison group will receive standard care. You may be eligible if: - You are 18 years of age or older - You are on a mechanical ventilator in the ICU - You have been diagnosed with sepsis or severe sepsis - You are expected to remain in the ICU for at least 4 days and on the ventilator for at least 48 hours You may NOT be eligible if: - You have a known neuromuscular disease or brain condition - You have had an amputation of a lower limb - You were unable to walk before becoming ill - You are considered likely to die within 36 hours - You are pregnant or have a BMI above 40 - You have a pacemaker or defibrillator implanted - You have external metal fixators, open wounds, or skin abrasions on the legs Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 und

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.