Table 2

Study secondary and clinical outcomes (in-hospital)


Intervention n=80Control n=82Mean difference*† (intervention minus control) with 95% CI
Mortality over follow-up, n (%)
ICU‡20 (25%)14 (17%)8% (–5% to 20%) †
Hospital discharge24 (30%)15 (18%)12% (–1% to 25%) †
6 months30 (38%)25 (30%)7% (–8% to 22%)†
12 months32 (40%)27 (33%)7% (–8% to 22%)†
Sedation and delirium in ICU
Delirium incidence in ICU, n (%)47 (59%)44 (55%)
Delirium days in ICU, median (IQR)2 (2–6)3 (2–6)−1.0 (−3.0 to 0.7)†
Comatose days, median (IQR)2 (0–7)2 (0–5)
Ultrasound cross-sectional area of rectus femoris (baseline to hospital discharge), % change (95% CI)
FES leg§−6.8 (−21.0 to 7.4)
Control§−15.5 (−26.3 to −4.7)
FES-cycling versus control group−7.2 (−41.7 to 27.2)*
Strength and physical function at ICU and hospital discharge
Quadriceps strength (Nm), mean (SD)¶57.3 (21.6)53.1 (24.1)4.7 (−4.7 to 14.1)†
ICU-acquired weakness at ICU discharge, n (%)**11 (19%)15 (26%)−7% (−22% to 8%)†
MRC sum score (MRC) at ICU discharge (points), mean (SD)**††51.8 (7.1)50.3 (8.7)1.4 (−1.5 to 4.3)†
MRC at hospital discharge: FES-cycling versus control0.0 (−0.5 to 0.5)*
PFITs‡‡ score at ICU discharge, mean (SD)§§6.4 (2.4)5.1 (3.0)1.3 (0.4 to 2.3)†
FSS-ICU¶¶ score at ICU discharge, mean (SD)§§20.4 (9.7)15.9 (10.0)4.5 (1.1 to 8.0)†
Participants who ambulated in ICU, n (%)***33 (41%)32 (39%)2% (–13% to 17%)†
Grip strength (kg) at hospital discharge†††, mean (SD)21.8 (10.0)21.1 (10.9)0.8 (−3.3 to 4.8)†
6 min walk distance (m) at hospital discharge‡‡‡, mean (SD)249 (118)240 (140)9 (−46 to 64)†
Healthcare resource utilisation
Duration of mechanical ventilation days, median (IQR)7 (4–11)7 (4–10)
ICU length of stay, median (IQR)10 (7–17)10 (7–17)
Hospital length of stay, median (IQR)21 (12–38)23 (14–41)
Discharge from hospital to home, n (%)37 (66%)37 (55%)
  • *Mean differences calculated on imputed data set.

  • †Mean differences calculated on complete cases.

  • ‡In the intervention group, 17 of 20 (85%) decedents had not received a completed FES-cycling intervention (≥10 min) prior to death due to not meeting safety criteria (online supplementary table 1) to commence the intervention.

  • §For ultrasound CSA n=31 (FES-cycle leg), n=40 (control).

  • ¶For quadriceps strength (complete cases) at hospital discharge n=49 (FES-cycle leg), n=55 (control).

  • **For ICU-acquired weakness and MRC sum score n=58 (intervention), n=58 (control).

  • ††MRC sum score (0–60) higher values indicate better strength.

  • ‡‡PFITs range 0–10, with higher scored indicating better function.

  • §§PFITs and FSS-ICU n=60 (intervention) and n=68 (control).

  • ¶¶FSS-ICU range 0–35, with higher scores indicating better physical function.

  • ***Ambulated defined as ICU mobility scale ≥IMS 7.

  • †††For grip strength n=48 (intervention) and n=57 (control).

  • ‡‡‡For 6 min walk distance n=39 (intervention) and n=49 (control).

  • FSS-ICU, Functional Status Score for the ICU; IMS, ICU mobility scale; MRC, Medical Research Council; PFITs, Physical Function in ICU Test scored.