Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients

Michelle E Kho, Alexander J Molloy, France J Clarke, Julie C Reid, Margaret S Herridge, Timothy Karachi, Bram Rochwerg, Alison E Fox-Robichaud, Andrew Je Seely, Sunita Mathur, Vincent Lo, Karen Ea Burns, Ian M Ball, Joseph R Pellizzari, Jean-Eric Tarride, Jill C Rudkowski, Karen Koo, Diane Heels-Ansdell, Deborah J Cook, Michelle E Kho, Alexander J Molloy, France J Clarke, Julie C Reid, Margaret S Herridge, Timothy Karachi, Bram Rochwerg, Alison E Fox-Robichaud, Andrew Je Seely, Sunita Mathur, Vincent Lo, Karen Ea Burns, Ian M Ball, Joseph R Pellizzari, Jean-Eric Tarride, Jill C Rudkowski, Karen Koo, Diane Heels-Ansdell, Deborah J Cook

Abstract

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 1-2 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.

Keywords: *respiration, artificial/adverseeffects/ methods; bed rest/ adverse effects; critical care; critical illness/*rehabilitation; exercise therapy.

Conflict of interest statement

Competing interests: Restorative Therapies (Baltimore, MD) provided 2 RT-300 supine cycle ergometers for Toronto General Hospital and London Health Sciences sites for this research.

Figures

Figure 1
Figure 1
Patient flow diagram. Multiple reasons may account for patient exclusions or patients eligible but not randomised. ICU, intensive care unit; MV, mechanically ventilated; PFIT-s, Physical Function ICU Test-scored; PT, physiotherapist.

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