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| Name | Class |
|---|---|
| St. Joseph's Healthcare Hamilton | OTHER |
| Hamilton Health Sciences Corporation | OTHER |
| Technology Evaluation in the Elderly Network / Canadian Frailty Network | UNKNOWN |
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Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very weak and disabled. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU discharge. In-bed cycling involves use of special equipment that attaches to a patient's hospital bed, allowing them gentle exercise while in the ICU.
Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Patients will randomly receive 30 minutes of in-bed cycling each day they are in the ICU or routine physiotherapy, both delivered by specially trained physiotherapists.
Outcomes: Feasibility: The investigators will study whether patients can cycle on most days of their ICU stay, whether patients and their families agree to be a part of the study, and whether investigators can systematically assess patients' strength.
Relevance: Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot randomized study is the second of several future larger studies about in-bed cycling in the ICU.
Our pilot work includes CYCLE Pilot and CYCLE Vanguard. CYCLE Pilot is an external pilot and enrolled 66 patients from 3/2015 to 6/2016. CYCLE Vanguard is an internal pilot and enrolled 47 patients from 11/2016 to 3/2018. CYCLE Vanguard patients will be analyzed in the main CYCLE RCT (NCT03471247).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Cycling and routine physiotherapy | Experimental | Patients will receive 30 minutes of in-bed cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay |
|
| Routine physiotherapy | Active Comparator | Patients will receive routine physiotherapy per current institutional practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-bed cycle ergometer (Restorative Therapies RT300 Supine) | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient accrual | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cycling protocol violations (% cycling protocol violations) | % cycling protocol violations | 2 years |
| Outcome measure ascertainment (% outcomes measured in hospital) | % outcomes measured in hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Katz Activities of Daily Living Scale at ICU and hospital discharge | The patient's ability to complete 6 tasks: bathing, dressing, toileting, feeding, continence, and bed mobility. A rater assesses whether the patient is dependent or independent according to pre-specified criteria. | From study admission to approximately 12 and 30 days, on average, respectively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Kho, PT, PhD | McMaster University School of Rehabilitation Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Austin Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30956804 | Result | Kho ME, Molloy AJ, Clarke FJ, Reid JC, Herridge MS, Karachi T, Rochwerg B, Fox-Robichaud AE, Seely AJ, Mathur S, Lo V, Burns KE, Ball IM, Pellizzari JR, Tarride JE, Rudkowski JC, Koo K, Heels-Ansdell D, Cook DJ. Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients. BMJ Open Respir Res. 2019 Feb 18;6(1):e000383. doi: 10.1136/bmjresp-2018-000383. eCollection 2019. | |
| 39467285 |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Canadian Institutes of Health Research (CIHR) |
| OTHER_GOV |
| Ontario Lung Association | OTHER |
| Canadian Respiratory Research Network | UNKNOWN |
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| Routine physiotherapy | Other | activities to assist with optimizing airway clearance and respiratory function, and, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out of bed mobility, and ambulation |
|
| 2 years |
| Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors) | % outcomes at hospital discharge measured by blinded outcome assessors | 2 years |
| Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only) and hospital discharge | Patients complete 4 activities: arm and leg strength, ability to stand, and step cadence. Scores range from 0 to 10, with higher scores = better function | From study admission to approximately 5, 12, 15 and 30 days, on average, respectively |
| Muscle strength at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only), and hospital discharge | Manual muscle testing using the Medical Research Council (MRC) Scale. The patient exerts a force against the examiner's resistance. Each muscle is assessed on a 6-point MRC scale (0=no contraction; 5=contraction sustained against maximal resistance). | From study admission to approximately 5, 12, 15 and 30 days, on average, respectively |
| Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale) | The patient exerts a force against a small strain gauge that fits in the examiner's hand. . | From study admission to approximately 12 and 30 days, on average, respectively |
| 2 minute walk test at ICU discharge, 3-days post-ICU (CYCLE Vanguard only), and hospital discharge | Maximum distance walked in 2 minutes measured in metres on a continuous scale | From study admission to approximately 12 and 30 days, on average, respectively |
| Euro-QOL 5DL | 5 question self-administered, preference-based instrument to measure mobility, self-care, usual activities, pain, and anxiety/ depression, as well as a global assessment of health | From study admission to approximately 12 and 30 days, on average, respectively |
| Melbourne |
| Victoria |
| 3084 |
| Australia |
| St. Joseph's Healthcare Intensive Care Unit | Hamilton | Ontario | L8N 4A6 | Canada |
| Hamilton Health Sciences General ICU | Hamilton | Ontario | Canada |
| Hamilton Health Sciences Juravinski ICU | Hamilton | Ontario | Canada |
| London Health Sciences | London | Ontario | Canada |
| Ottawa General Hospital | Ottawa | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Toronto General Hospital | Toronto | Ontario | Canada |
| Derived |
| Heels-Ansdell D, Kelly L, O'Grady HK, Farley C, Reid JC, Berney S, Pastva AM, Burns KE, D'Aragon F, Herridge MS, Seely A, Rudkowski J, Rochwerg B, Fox-Robichaud A, Ball I, Lamontagne F, Duan EH, Tsang J, Archambault PM, Verceles AC, Muscedere J, Mehta S, English SW, Karachi T, Serri K, Reeve B, Thabane L, Cook D, Kho ME. Early In-Bed Cycle Ergometry With Critically Ill, Mechanically Ventilated Patients: Statistical Analysis Plan for CYCLE (Critical Care Cycling to Improve Lower Extremity Strength), an International, Multicenter, Randomized Clinical Trial. JMIR Res Protoc. 2024 Oct 28;13:e54451. doi: 10.2196/54451. |
| 39317833 | Derived | O'Grady HK, Ball I, Berney S, Burns KEA, Cook DJ, Fox-Robichaud A, Herridge MS, Karachi T, Mathur S, Reid JC, Rochwerg B, Rollinson T, Rudkowski JC, Bosch J, Turkstra LS, Kho ME. Characterizing usual-care physical rehabilitation in Canadian intensive care unit patients: a secondary analysis of the Canadian multicentre Critical Care Cycling to Improve Lower Extremity Strength pilot randomized controlled trial. Can J Anaesth. 2024 Oct;71(10):1406-1416. doi: 10.1007/s12630-024-02838-7. Epub 2024 Sep 24. |
| 38865147 | Derived | Kho ME, Berney S, Pastva AM, Kelly L, Reid JC, Burns KEA, Seely AJ, D'Aragon F, Rochwerg B, Ball I, Fox-Robichaud AE, Karachi T, Lamontagne F, Archambault PM, Tsang JL, Duan EH, Muscedere J, Verceles AC, Serri K, English SW, Reeve BK, Mehta S, Rudkowski JC, Heels-Ansdell D, O'Grady HK, Strong G, Obrovac K, Ajami D, Camposilvan L, Tarride JE, Thabane L, Herridge MS, Cook DJ. Early In-Bed Cycle Ergometry in Mechanically Ventilated Patients. NEJM Evid. 2024 Jul;3(7):EVIDoa2400137. doi: 10.1056/EVIDoa2400137. Epub 2024 Jun 12. |
| 37355270 | Derived | Kho ME, Reid J, Molloy AJ, Herridge MS, Seely AJ, Rudkowski JC, Buckingham L, Heels-Ansdell D, Karachi T, Fox-Robichaud A, Ball IM, Burns KEA, Pellizzari JR, Farley C, Berney S, Pastva AM, Rochwerg B, D'Aragon F, Lamontagne F, Duan EH, Tsang JLY, Archambault P, English SW, Muscedere J, Serri K, Tarride JE, Mehta S, Verceles AC, Reeve B, O'Grady H, Kelly L, Strong G, Hurd AH, Thabane L, Cook DJ; CYCLE Investigators and the Canadian Critical Care Trials Group. Critical Care Cycling to Improve Lower Extremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients. BMJ Open. 2023 Jun 23;13(6):e075685. doi: 10.1136/bmjopen-2023-075685. |
| 33331622 | Derived | Takaoka A, Heels-Ansdell D, Cook DJ, Kho ME. The Association between Frailty and Short-Term Outcomes in an Intensive Care Unit Rehabilitation Trial: An Exploratory Analysis. J Frailty Aging. 2021;10(1):49-55. doi: 10.14283/jfa.2020.52. |
| 31741746 | Derived | Reid JC, McCaskell DS, Kho ME. Therapist perceptions of a rehabilitation research study in the intensive care unit: a trinational survey assessing barriers and facilitators to implementing the CYCLE pilot randomized clinical trial. Pilot Feasibility Stud. 2019 Nov 12;5:131. doi: 10.1186/s40814-019-0509-3. eCollection 2019. |
| 31455384 | Derived | McCaskell DS, Molloy AJ, Childerhose L, Costigan FA, Reid JC, McCaughan M, Clarke F, Cook DJ, Rudkowski JC, Farley C, Karachi T, Rochwerg B, Newman A, Fox-Robichaud A, Herridge MS, Lo V, Feltracco D, Burns KE, Porteous R, Seely AJE, Ball IM, Seczek A, Kho ME. Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial. Trials. 2019 Aug 28;20(1):532. doi: 10.1186/s13063-019-3634-7. |
| 27059469 | Derived | Kho ME, Molloy AJ, Clarke F, Herridge MS, Koo KK, Rudkowski J, Seely AJ, Pellizzari JR, Tarride JE, Mourtzakis M, Karachi T, Cook DJ; Canadian Critical Care Trials Group. CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients. BMJ Open. 2016 Apr 8;6(4):e011659. doi: 10.1136/bmjopen-2016-011659. |