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Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients [with consumer summary]
Kho ME, Molloy AJ, Clarke FJ, Reid JC, Herridge MS, Karachi T, Rochwerg B, Fox-Robichaud AE, Seely AJE, Mathur S, Lo V, Burns KEA, Ball IM, Pellizzari JR, Tarride J-E, Rudkowski JC, Koo K, Heels-Ansdell D, Cook DJ, Canadian Critical Care Trials Group
BMJ Open Respiratory Research 2019 Feb;6(1):e000383
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

INTRODUCTION: Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient's ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients. METHODS: We conducted a pilot RCT conducted in seven Canadian medical-surgical ICUs. We enrolled adults who could ambulate independently before ICU admission, within the first 4 days of invasive MV and first 7 days of ICU admission. Following informed consent, patients underwent concealed randomisation to either 30 min/day of in-bed cycling and routine physiotherapy (cycling) or routine physiotherapy alone (routine) for 5 days/week, until ICU discharge. Our feasibility outcome targets included: accrual of 1 to 2 patients/month/site; > 80% cycling protocol delivery; > 80% outcomes measured and > 80% blinded outcome measures at hospital discharge. We report ascertainment rates for our primary outcome for the main trial (Physical Function ICU Test-scored (PFIT-s) at hospital discharge). RESULTS: Between 3/2015 and 6/2016, we randomised 66 patients (36 cycling, 30 routine). Our consent rate was 84.6% (66/78). Patient accrual was (mean (SD)) 1.1 (0.3) patients/month/site. Cycling occurred in 79.3% (146/184) of eligible sessions, with a median (IQR) session duration of 30.5 (30.0, 30.7) min. We recorded 43 (97.7%) PFIT-s scores at hospital discharge and 37 (86.0%) of these assessments were blinded. DISCUSSION: Our pilot RCT suggests that a future multicentre RCT of early in-bed cycling for MV patients in the ICU is feasible. TRIAL REGISTRATION NUMBER: NCT02377830.

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