CYCLE pilot RCT schedule of enrolment, interventions and assessments
Study period | |||||||
---|---|---|---|---|---|---|---|
Enrolment | Allocation | Postallocation | Close out | ||||
Time point | ICU admission | 0 | In ICU | ICU awakening | ICU discharge | Hospital discharge | |
Enrolment | |||||||
Eligibility screening | X | ||||||
Informed consent | X | ||||||
Allocation | X | ||||||
Interventions | |||||||
In-bed cycling+routine PT | X | X | X | ||||
Routine PT | X | X | X | ||||
Assessments | |||||||
Severity of illness: APACHE II | X | ||||||
Charlson comorbidity index56 | X | ||||||
Functional comorbidity index57 | X | ||||||
Clinical Frailty Scale43 | X | X | X | ||||
Function: Katz activities of daily living scale44 | X | X | X | ||||
Physical strength and function* | X | X | X (blinded) | ||||
Psychological distress: Intensive Care Psychological Assessment Tool45 | X | ||||||
Quality of life: Euro-QOL 5DL47 48 | X | X | |||||
ICU and hospital length of stay | X | X | |||||
Mortality | X | X | X |
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.