Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients
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...
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BMJ Publishing Group
2019-10-01
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| Series: | BMJ Open Respiratory Research |
| Online Access: | https://bmjopenrespres.bmj.com/content/6/1/e000383.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Michelle E Kho |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a51aed9860a54ccb8bb9805edf9e19d3 |
| institution | OA Journals |
| issn | 2052-4439 |
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| publishDate | 2019-10-01 |
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| series | BMJ Open Respiratory Research |
| spelling | doaj-art-a51aed9860a54ccb8bb9805edf9e19d32025-08-20T02:10:53ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392019-10-016110.1136/bmjresp-2018-000383Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patientsMichelle E Kho0Alexander J Molloy1France J Clarke2Julie C Reid3Margaret S Herridge4Timothy Karachi5Bram Rochwerg6Alison E Fox-Robichaud7Andrew JE Seely8Sunita Mathur9Vincent Lo10Karen EA Burns11Ian M Ball12Joseph R Pellizzari13Jean-Eric Tarride14Jill C Rudkowski15Karen Koo16Diane Heels-Ansdell17Deborah J Cook182 Physiotherapy Department, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada2 Physiotherapy Department, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, CanadaDepartment of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, CanadaDepartment of Health Research Methods, Evidence, and Impact, McMaster University Medical Centre, Hamilton, Ontario, Canada2 Interdepartmental Division of Critical Care Medicine and Department of Medicine, University of Toronto, Toronto, Ontario, Canada5 Department of Medicine, McMaster University, Hamilton, Ontario, Canada5 Department of Medicine, McMaster University, Hamilton, Ontario, Canada6 Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada7 Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada8 Department of Physical Therapy, University of Toronto, Toronto, Ontario, Canada1 Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong11 Interdepartmental Division of Critical Care and the Li Ka Shing Knowledge Institute, St. Michael`s Hospital, Toronto, Ontario, Canada12 Department of Medicine, Western University, London, Ontario, Canada14 Consultation-Liaison Psychiatry Service, St. Joseph`s Healthcare Hamilton, Hamilton, Ontario, CanadaDepartment of Health Research Methods, Evidence, and Impact (HEI), Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University, Ontario, CanadaDepartment of Critical Care, St. Joseph`s Healthcare Hamilton, Hamilton, Ontario, Canada16 Swedish Medical Group, Seattle, Washington, USAstatisticianprofessorIntroduction 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.https://bmjopenrespres.bmj.com/content/6/1/e000383.full |
| spellingShingle | 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 Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients BMJ Open Respiratory Research |
| title | Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients |
| title_full | Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients |
| title_fullStr | Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients |
| title_full_unstemmed | Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients |
| title_short | Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients |
| title_sort | multicentre pilot randomised clinical trial of early in bed cycle ergometry with ventilated patients |
| url | https://bmjopenrespres.bmj.com/content/6/1/e000383.full |
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