Table 1

Inclusion and exclusion criteria for study entry

Inclusion criteriaExclusion criteriaRationale for exclusion
  1. >18 years old

  2. Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation ≥48 hours

  3. Expected ICU stay ≥4 days after enrolment (to permit adequate exposure to the proposed intervention)

1. >96 continuous hours of mechanical ventilation before enrolmentIntervention most effective delivered early85
2. Expected death or withdrawal of life-sustaining treatments within this hospitalisationPatients unlikely to receive benefit
3. No expectation for any nutritional intake within the subsequent 72 hoursIntervention intended to occur in addition to standard clinical nutritional intake
4. Severe chronic liver disease (MELD score ≥20) or acute hepatic failureAmino acid supplementation may be harmful in patients with severe liver disease
5. Documented allergy to the amino acid interventionUnable to receive proposed intervention
6. Metabolic disorders involving impaired nitrogen utilisationUnable to receive amino acid infusion
7. Not ambulating independently prior to illness that leads to ICU admission (use of gait aid permitted)Unable to perform outcome assessments
8. Pre-existing primary systemic neuromuscular disease (eg, Guillain Barre)May not benefit from proposed intervention (ie, different mechanism of muscle weakness)
9. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)Do not meet safety criteria for cycling intervention
10. Intracranial or spinal process affecting motor functionMay not benefit from proposed intervention (ie, different mechanism of muscle weakness)
11. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessmentUnable to perform outcome assessments
12. Patients in hospital >5 days prior to ICU admissionMuscle weakness likely already established
13. Lower extremity impairments that prevent cycling (eg, amputation, knee/hip injury)Unable to receive proposed cycling intervention
14. Remaining intubated for airway protection onlyLess likely to have muscle weakness and benefit from the interventions
15. Weight ≥150 kgExceeds maximum weight permitted for use of the cycle device
16. Physician declines patient enrolmentNot appropriate to conduct trial
17. Insufficient intravenous accessNeed dedicated access for nutrition intervention for several hours a day
18. PregnantUnknown effects in fetus
19. IncarceratedVulnerable population
  • ICU, intensive care unit.