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
Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients' short-term physical function. Before unblinding and trial database lock...
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| Published in | JMIR research protocols Vol. 13; p. e54451 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Canada
JMIR Publications
28.10.2024
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1929-0748 1929-0748 |
| DOI | 10.2196/54451 |
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| Abstract | Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients' short-term physical function.
Before unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT).
CYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female).
CYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024.
We developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions.
ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830.
RR1-10.2196/54451. |
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| AbstractList | Background:Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients’ short-term physical function.Objective:Before unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT).Methods:CYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female).Results:CYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024.Conclusions:We developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions.Trial Registration:ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830International Registered Report Identifier (IRRID):RR1-10.2196/54451 BackgroundSurvivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients’ short-term physical function. ObjectiveBefore unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT). MethodsCYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female). ResultsCYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024. ConclusionsWe developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions. Trial RegistrationClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830 International Registered Report Identifier (IRRID)RR1-10.2196/54451 Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients' short-term physical function.BACKGROUNDSurvivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients' short-term physical function.Before unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT).OBJECTIVEBefore unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT).CYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female).METHODSCYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female).CYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024.RESULTSCYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024.We developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions.CONCLUSIONSWe developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions.ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830.TRIAL REGISTRATIONClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830.RR1-10.2196/54451.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)RR1-10.2196/54451. Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients' short-term physical function. Before unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT). CYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female). CYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024. We developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions. ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830. RR1-10.2196/54451. |
| Author | Seely, Andrew Fox-Robichaud, Alison Archambault, Patrick M Berney, Sue Burns, Karen EA Muscedere, John Kelly, Laurel Serri, Karim Herridge, Margaret S Duan, Erick H Verceles, Avelino C Heels-Ansdell, Diane Tsang, Jennifer Reeve, Brenda Mehta, Sangeeta D'Aragon, Frédérick Ball, Ian Thabane, Lehana Karachi, Tim O'Grady, Heather K Farley, Christopher Rochwerg, Bram English, Shane W Lamontagne, Francois Rudkowski, Jill Reid, Julie C Pastva, Amy M Cook, Deborah Kho, Michelle E |
| AuthorAffiliation | 4 Department of Physiotherapy Austin Health Heidelberg Australia 7 Li Sha King Knowledge Institute St. Michael's Hospital Toronto, ON Canada 19 Department of Anesthesiology and Intensive Care Faculty of Medicine Université Laval Quebec, QC Canada 21 Centre de recherche intégrée pour un système apprenant en santé et services sociaux Centre intégré de santé et de services sociaux de Chaudière-Appalaches Lévis, QC Canada 22 Department of Medicine University of Maryland Medical Centre, Midtown Campus Baltimore, MD United States 14 Department of Surgery University of Ottawa Ottawa, ON Canada 9 Department of Medicine Faculty of Medicine and Health Sciences Université de Sherbrooke Sherbrooke, QC Canada 23 Division of Pulmonary and Critical Care Medicine University of Maryland School of Medicine Baltimore, MD United States 6 Duke University School of Medicine Department of Orthopedic Surgery, Physical Therapy Division Durham, NC United States 12 Department of Medicine, Interdepartmental Division of Cr |
| AuthorAffiliation_xml | – name: 8 Interdepartmental Division of Critical Care University of Toronto Toronto, ON Canada – name: 26 Department of Medicine (Critical Care) University of Ottawa Ottawa, ON Canada – name: 17 Department of Medicine Western University London, ON Canada – name: 6 Duke University School of Medicine Department of Orthopedic Surgery, Physical Therapy Division Durham, NC United States – name: 14 Department of Surgery University of Ottawa Ottawa, ON Canada – name: 11 Centre de recherche du Centre hospitalier universitaire de Sherbrooke Sherbrooke, QC Canada – name: 20 Department of Family and Emergency Medicine Université Laval Québec, QC Canada – name: 27 School of Epidemiology and Public Health University of Ottawa Ottawa, ON Canada – name: 10 Department of Anesthesiology Faculty of Medicine and Health Sciences Université de Sherbrooke Sherbrooke, QC Canada – name: 12 Department of Medicine, Interdepartmental Division of Critical Care Medicine Toronto General Research Institute, Institute of Medical Science, University Health Network, University of Toronto Toronto, ON Canada – name: 30 Research Institute of St. Joseph's Hamilton, ON Canada – name: 15 Department of Medicine McMaster University Hamilton, ON Canada – name: 18 Division of Critical Care Medicine Niagara Health St. Catharines, ON Canada – name: 19 Department of Anesthesiology and Intensive Care Faculty of Medicine Université Laval Quebec, QC Canada – name: 4 Department of Physiotherapy Austin Health Heidelberg Australia – name: 29 Department of Medicine Brantford General Hospital Brantford, ON Canada – name: 28 Critical Care Division, Department of Medicine, Centre de Recherche de Hôpital du Sacré-Cœur de Montréal Hôpital Sacré-Coeur de Montréal Montreal, QC Canada – name: 9 Department of Medicine Faculty of Medicine and Health Sciences Université de Sherbrooke Sherbrooke, QC Canada – name: 1 Department of Health Research Methods, Evidence, and Impact McMaster University Hamilton, ON Canada – name: 5 Department of Physiotherapy The University of Melbourne Parkville Australia – name: 3 School of Rehabilitation Science Faculty of Health Sciences McMaster University Hamilton, ON Canada – name: 13 Ottawa Hospital Research Institute University of Ottawa Ottawa, ON Canada – name: 16 Department of Epidemiology and Biostatistics Western University London, ON Canada – name: 22 Department of Medicine University of Maryland Medical Centre, Midtown Campus Baltimore, MD United States – name: 25 Department of Medicine Sinai Health System Toronto, ON Canada – name: 2 Physiotherapy Department St. Joseph's Healthcare Hamilton Hamilton, ON Canada – name: 23 Division of Pulmonary and Critical Care Medicine University of Maryland School of Medicine Baltimore, MD United States – name: 24 Department of Critical Care Medicine Queen's University Kingston, ON Canada – name: 21 Centre de recherche intégrée pour un système apprenant en santé et services sociaux Centre intégré de santé et de services sociaux de Chaudière-Appalaches Lévis, QC Canada – name: 7 Li Sha King Knowledge Institute St. Michael's Hospital Toronto, ON Canada |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/39467285$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | Diane Heels-Ansdell, Laurel Kelly, Heather K O'Grady, Christopher Farley, Julie C Reid, Sue Berney, Amy M Pastva, Karen EA Burns, Frédérick D'Aragon, Margaret S Herridge, Andrew Seely, Jill Rudkowski, Bram Rochwerg, Alison Fox-Robichaud, Ian Ball, Francois Lamontagne, Erick H Duan, Jennifer Tsang, Patrick M Archambault, Avelino C Verceles, John Muscedere, Sangeeta Mehta, Shane W English, Tim Karachi, Karim Serri, Brenda Reeve, Lehana Thabane, Deborah Cook, Michelle E Kho. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 28.10.2024. 2024. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. Diane Heels-Ansdell, Laurel Kelly, Heather K O'Grady, Christopher Farley, Julie C Reid, Sue Berney, Amy M Pastva, Karen EA Burns, Frédérick D'Aragon, Margaret S Herridge, Andrew Seely, Jill Rudkowski, Bram Rochwerg, Alison Fox-Robichaud, Ian Ball, Francois Lamontagne, Erick H Duan, Jennifer Tsang, Patrick M Archambault, Avelino C Verceles, John Muscedere, Sangeeta Mehta, Shane W English, Tim Karachi, Karim Serri, Brenda Reeve, Lehana Thabane, Deborah Cook, Michelle E Kho. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 28.10.2024. 2024 |
| Copyright_xml | – notice: Diane Heels-Ansdell, Laurel Kelly, Heather K O'Grady, Christopher Farley, Julie C Reid, Sue Berney, Amy M Pastva, Karen EA Burns, Frédérick D'Aragon, Margaret S Herridge, Andrew Seely, Jill Rudkowski, Bram Rochwerg, Alison Fox-Robichaud, Ian Ball, Francois Lamontagne, Erick H Duan, Jennifer Tsang, Patrick M Archambault, Avelino C Verceles, John Muscedere, Sangeeta Mehta, Shane W English, Tim Karachi, Karim Serri, Brenda Reeve, Lehana Thabane, Deborah Cook, Michelle E Kho. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 28.10.2024. – notice: 2024. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: Diane Heels-Ansdell, Laurel Kelly, Heather K O'Grady, Christopher Farley, Julie C Reid, Sue Berney, Amy M Pastva, Karen EA Burns, Frédérick D'Aragon, Margaret S Herridge, Andrew Seely, Jill Rudkowski, Bram Rochwerg, Alison Fox-Robichaud, Ian Ball, Francois Lamontagne, Erick H Duan, Jennifer Tsang, Patrick M Archambault, Avelino C Verceles, John Muscedere, Sangeeta Mehta, Shane W English, Tim Karachi, Karim Serri, Brenda Reeve, Lehana Thabane, Deborah Cook, Michelle E Kho. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 28.10.2024. 2024 |
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| DOI | 10.2196/54451 |
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| Keywords | cycle ergometry rehabilitation exercise therapy mechanical ventilation critical illness recovery of function |
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| Snippet | Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation... Background:Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation... BackgroundSurvivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation... |
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| SubjectTerms | Adult Age Clinical trials Consent Critical care Critical Care - methods Critical Illness Ergometry - methods Ethics Female Frailty Guillain-Barre syndrome Humans Intensive care Intensive Care Units Intervention Lower Extremity Male Middle Aged Muscle Strength Patients Physical therapy Proposal Quantitative psychology Randomized Controlled Trials as Topic Regression analysis Rehabilitation Respiration, Artificial Statistical analysis Ventilators |
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| Title | 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 |
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