Table 1.
Inclusion and exclusion criteria.
Fig 1.
ICU rehabilitation protocol with exercise intervention using in-bed cycle ergometer/stepper.
Critically ill patients will be classified from red to violet according to Richmond agitation-sedation scale (RASS), motor power, and level of consciousness. The patients in the control group will receive conventional rehabilitation according to the ICU rainbow mobilization scale program including range of motion (ROM), sitting, standing, and ambulation. Critically ill patients in the intervention group will receive in-bed cycling/stepping intervention starting from Yellow to Violet in addition to the conventional rehabilitation. As the condition of the critically ill patient improves from Yellow to Violet, the exercise intervention gradually progresses to passive, active assistive, active, and resistive exercise modes. In-bed cycling/stepping is provided by physiotherapists from ICU admission to discharge, and the routine frequency of in-bed cycling/stepping is 1–3 sessions per day on the weekdays during ICU hospitalization. The number of in-bed cycling/stepping will be increased gradually. Cycling is performed if there is one session per day; cycling-stepping is performed if there are two sessions per day; and cycling-stepping-cycling is performed if there are three sessions per day. ROM: range of motion; UE: upper extremity; LE: lower extremity.
Table 2.
Criteria for delaying or terminating ICU rehabilitation and exercise intervention.
Table 3.
Clinical examination items.
Fig 2.
SPIRIT schedule of enrolment, interventions, and assessments of the study.
The outcomes are the number and percentage of completed in-bed cycling/stepping sessions, the duration and percentage of in-bed cycling/stepping sessions, and the number of cessations of in-bed cycling/stepping sessions, the interval from ICU admission to the first session of in-bed cycling/stepping, the number and percentage of completed conventional rehabilitation sessions, the duration and percentage of conventional rehabilitation sessions, the number of cessations of conventional rehabilitation sessions, the number of adverse events, CAM-ICU, RASS, FAC, FSS-ICU, DEMMI, FES, ABC, Sum of MRC, MBI, SF-36 version 2.0, PRPS, days to initiate ambulation (FAC≥2) and others. ICU: intensive care unit; D/C: discharge; FAC: functional ambulation category; RASS: Richmond agitation-sedation scale; CAM-ICU: confusion assessment method for the ICU; MRC: Medical Research Council; DEMMI: de Morton mobility index; FSS-ICU: functnal status score for the ICU; SPPB: short physical performance battery score; MBI: modified Barthel index; SF-36: 36-item short form survey; FES: falls efficacy scale; ABC: activities-specific balance confidence scale; PRPS: Pittsburgh rehabilitation participation scale.
Table 4.
Lists of predicted adverse events.