Muscle Wasting in the Critically Ill
Condition: Muscle Weakness
MeSH terms: Muscle Weakness; Muscular Atrophy
Study type: Interventional

Summary: 
      Muscle wasting is a common consequence of critical illness, and has a profound impact upon
      the rehabilitation of those who survive admission to critical to care. The investigators
      intend to assess if the application of 10 sessions over two weeks of passive cycling with
      electrical stimulation to the lower limbs and abdomen can prevent muscle loss, or at least
      cause less muscle loss, compared to patients who receive standard daily sessions of
      physiotherapy. This will be done by comparing the changes in muscle size on ultrasound
      between the two groups, comparing functional measures at a 3 month follow up, and by
      performing translational research using tissue samples taken during the study.
    

Detailed description: 
      Patients are mechanically ventilated and sedated with a diagnosis of sepsis (from any source)
      will be eligible for this study. Provided they meet the inclusion criteria, they will be
      randomised within 48 hours of admission, to either ten 30 minute sessions of passive cycling
      with functional electrical stimulation (FES) to the thighs, hamstrings, calves and abdomen
      over a 14 day period, or to a control group of routine physiotherapy. The trial group will
      also receive this physiotherapy.

      On admission to the study, all patients will receive on day 1:

      Ultrasound measurements of:

      Rectus femoris cross-sectional area Thickness of rectus femoris and vastus intermedius
      Thickness, pennation angle and derived fascicle length of vastus lateralis and medial head of
      gastrocnemius Thickness of rectus abdominis. Thickness of diaphragm

      A blood sample taken from an arterial line A urine sample taken from a urinary catheter A
      muscle biopsy taken from the right vastus lateralis

      They will then receive ten 30 minute sessions of passive cycling with functional electrical
      stimulation over 14 days, or a control group will receive routine physiotherapy during this
      period.

      Repeat ultrasounds will be taken at days 3, 5, 7, 10 and 14. Repeat blood and urine sampling
      at days 5, 10 and 14. Repeat muscle biopsy at day 14.

      All cycling, ultrasounds and tissue sampling will end on day 14 regardless of the ventilator
      status of the patient.

      In patients who survive to be discharged from critical care, they will be followed up at 3
      months for:

      Repeat ultrasound scan of all muscles listed Six minute walk test Hand grip and lower limb
      dynamometry, Balance testing (by standing upright on a pressure plate for 20 seconds)
      Psychological assessment using the 36 item Short Form (SF-36) questionnaire

      Tissue sampling will be stored in the University of Liverpool for analysis of biomarkers of
      muscle damage and loss between the two groups.
    

Intervention name(s): Cycling with FES; Routine physiotherapy
Intervention type(s): Device; Other
Intervention description(s): As described already; As described already
Other intervention name(s): RT-300 Supine; Restorative Therapies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: ICU acquired weakness (ICU-AW); FES; Functional Electrical Stimulation; Rehabilitation