Title

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

Authors

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, Swedish Medical Group, Seattle, Washington, USAFollow
Diane Heels-Ansdell
Deborah J Cook

Document Type

Article

Publication Date

1-1-2019

Publication Title

BMJ Open Respir Res

Keywords

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

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.

Department

Critical Care Medicine

Recommended Citation

Kho, Michelle E; Molloy, Alexander J; Clarke, France J; Reid, Julie C; Herridge, Margaret S; Karachi, Timothy; Rochwerg, Bram; Fox-Robichaud, Alison E; Seely, Andrew Je; Mathur, Sunita; Lo, Vincent; Burns, Karen Ea; Ball, Ian M; Pellizzari, Joseph R; Tarride, Jean-Eric; Rudkowski, Jill C; Koo, Karen; Heels-Ansdell, Diane; and Cook, Deborah J, "Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients." (2019). Articles, Abstracts, and Reports. 1456.
https://digitalcommons.psjhealth.org/publications/1456