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

Diane Heels-Ansdell   ¹ , MSc ;   Laurel Kelly   ² , MScPT ;   Heather K O'Grady   ³ , BSc, PhD ;   Christopher Farley   ³ , MScPT ;   Julie C Reid   ^{1, 3} , MScPT, PhD ;   Sue Berney   ^{4, 5} , PT, PhD ;   Amy M Pastva   ⁶ , PT, PhD ;   Karen EA Burns   ^{7, 8} , MD, MSc ;   Frédérick D'Aragon   ^{9, 10, 11} , MD, MSc ;   Margaret S Herridge   ¹² , MD, MSc, MPH ;   Andrew Seely   ^{13, 14} , MD, PhD ;   Jill Rudkowski   ¹⁵ , MD ;   Bram Rochwerg   ^{1, 15} , MD, MSc ;   Alison Fox-Robichaud   ¹⁵ , MD, MSc ;   Ian Ball   ^{16, 17} , MD, MSc ;   Francois Lamontagne   ^{9, 11} , MD, MSc ;   Erick H Duan   ^{15, 18} , MD, MSc ;   Jennifer Tsang   ^{15, 18} , MD, PhD ;   Patrick M Archambault   ^{19, 20, 21} , MD, MSc ;   Avelino C Verceles   ^{22, 23} , MD, MSc ;   John Muscedere   ²⁴ , MD ;   Sangeeta Mehta   ^{8, 25} , MD ;   Shane W English   ^{13, 26, 27} , MD, MSc ;   Tim Karachi   ¹⁵ , MD ;   Karim Serri   ²⁸ , MD, PhD ;   Brenda Reeve   ²⁹ , MD ;   Lehana Thabane   ^{1, 30} , PhD ;   Deborah Cook   ^{1, 15, 30} , MD, MSc ;   Michelle E Kho   ^{2, 3, 30} , PT, PhD

¹ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada

² Physiotherapy Department, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada

³ School of Rehabilitation Science, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada

⁴ Department of Physiotherapy, Austin Health, Heidelberg, Australia

⁵ Department of Physiotherapy, The University of Melbourne, Parkville, Australia

⁶ Duke University School of Medicine, Department of Orthopedic Surgery, Physical Therapy Division, Durham, NC, United States

⁷ Li Sha King Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada

⁸ Interdepartmental Division of Critical Care, University of Toronto, Toronto, ON, Canada

⁹ Department of Medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, QC, Canada

¹⁰ Department of Anesthesiology, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, QC, Canada

¹¹ Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, QC, Canada

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

¹³ Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada

¹⁴ Department of Surgery, University of Ottawa, Ottawa, ON, Canada

¹⁵ Department of Medicine, McMaster University, Hamilton, ON, Canada

¹⁶ Department of Epidemiology and Biostatistics, Western University, London, ON, Canada

¹⁷ Department of Medicine, Western University, London, ON, Canada

¹⁸ Division of Critical Care Medicine, Niagara Health, St. Catharines, ON, Canada

¹⁹ Department of Anesthesiology and Intensive Care, Faculty of Medicine, Université Laval, Quebec, QC, Canada

²⁰ Department of Family and Emergency Medicine, Université Laval, Québec, 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

²³ Division of Pulmonary and Critical Care Medicine, University of Maryland School of Medicine, Baltimore, MD, United States

²⁴ Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada

²⁵ Department of Medicine, Sinai Health System, Toronto, ON, Canada

²⁶ Department of Medicine (Critical Care), University of Ottawa, Ottawa, ON, Canada

²⁷ School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada

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

²⁹ Department of Medicine, Brantford General Hospital, Brantford, ON, Canada

³⁰ Research Institute of St. Joseph's, Hamilton, ON, Canada