Use the Back button in your browser to see the other results of your search or to select another record.

Detailed Search Results

Functional electrical stimulation in-bed cycle ergometry in mechanically ventilated patients: a multicentre randomised controlled trial [with consumer summary]
Berney S, Hopkins RO, Rose JW, Koopman R, Puthucheary Z, Pastva A, Gordon I, Colantuoni E, Parry SM, Needham DM, Denehy L
Thorax 2021 Jul;76(7):656-663
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

PURPOSE: To investigate the effect of functional electrical stimulation-assisted cycle ergometry (FES-cycling) on muscle strength, cognitive impairment and related outcomes. METHODS: Mechanically ventilated patients aged >= 18 years with sepsis or systemic inflammatory response syndrome were randomised to either 60 min of FES-cycling >= 5 days/week while in the intensive care unit (ICU) plus usual care rehabilitation versus usual care rehabilitation alone, with evaluation of two primary outcomes: (1) muscle strength at hospital discharge and (2) cognitive impairment at 6-month follow-up. RESULTS: We enrolled 162 participants, across four study sites experienced in ICU rehabilitation in Australia and the USA, to FES-cycling (n = 80; mean age +/- SD 59 +/- 15) versus control (n = 82; 56 +/- 14). Intervention participants received a median (IQR) of 5 (3 to 9) FES-cycling sessions with duration of 56 (34 to 63) min/day plus 15 (10 to 23) min/day of usual care rehabilitation. The control group received 15 (8 to 15) min/day of usual care rehabilitation. In the intervention versus control group, there was no significant differences for muscle strength at hospital discharge (mean difference (95% CI) 3.3 (-5.0 to 12.1) Nm), prevalence of cognitive impairment at 6 months (OR 1.1 (95% CI 0.30 to 3.8)) or secondary outcomes measured in-hospital and at 6 and 12 months follow-up. CONCLUSION: In this randomised controlled trial, undertaken at four centres with established rehabilitation programmes, the addition of FES-cycling to usual care rehabilitation did not substantially increase muscle strength at hospital discharge. At 6 months, the incidence of cognitive impairment was almost identical between groups, but potential benefit or harm of the intervention on cognition cannot be excluded due to imprecision of the estimated effect. TRIAL REGISTRATION NUMBER: ACTRN12612000528853, NCT02214823.
Reproduced with permission from the BMJ Publishing Group.

Full text (sometimes free) may be available at these link(s):      help