Table 1

CYCLE pilot RCT schedule of enrolment, interventions and assessments

Study period
EnrolmentAllocationPostallocationClose out
Time pointICU admission0In ICUICU awakeningICU dischargeHospital discharge
Enrolment
 Eligibility screeningX
 Informed consentX
 AllocationX
Interventions
 In-bed cycling+routine PTXXX
 Routine PTXXX
Assessments
 Severity of illness: APACHE IIX
 Charlson comorbidity index56X
 Functional comorbidity index57X
 Clinical Frailty Scale43XXX
 Function: Katz activities of daily living scale44XXX
 Physical strength and function*XXX (blinded)
 Psychological distress: Intensive Care Psychological Assessment Tool45X
 Quality of life: Euro-QOL 5DL47 48XX
 ICU and hospital length of stayXX
 MortalityXXX
  • In this table, we outline patient enrolment, interventions and assessments in the CYCLE pilot RCT.

  • *Strength and function assessments at ICU awakening include Physical Function ICU Test (scored),31 ,32 Medical Research Council Sum Score34 ,35 and 30 s sit-to-stand test;37 ,38 at ICU discharge and hospital discharge, includes all ICU awakening assessments plus the 2 min walk test39 ,40 and quadriceps strength with hand-held dynamometry.36

  • ICU, intensive care unit; PT, physiotherapy; RCT, randomised clinical trial.