Christopher J Ryerson1,2, Pat G Camp3,2, Neil D Eves4, Michele Schaeffer3,2, Nafeez Syed3,2, Satvir Dhillon3,2, Dennis Jensen5, Francois Maltais6, Denis E O'Donnell7, Natya Raghavan8, Michael Roman9, Michael K Stickland10, Deborah Assayag11, Jean Bourbeau12, Genevieve Dion6, Charlene D Fell9, Nathan Hambly8, Kerri A Johannson9, Meena Kalluri13, Nasreen Khalil1, Martin Kolb8, Helene Manganas14, Onofre Morán-Mendoza7, Steve Provencher6, Warren Ramesh15, J Douglass Rolf1, Pearce G Wilcox1, Jordan A Guenette3,2. 1. 1 Department of Medicine. 2. 2 Centre for Heart Lung Innovation, University of British Columbia and St. Paul's Hospital, Vancouver, British Columbia, Canada. 3. 3 Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada. 4. 4 Centre for Heart, Lung and Vascular Health, University of British Columbia, Kelowna, British Columbia, Canada. 5. 5 Department of Kinesiology and Physical Education, McGill University; Division of Respiratory Medicine, Department of Medicine, McGill University and Research Institute of the McGill University Health Centre; and Centre for Innovative Medicine, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada. 6. 6 Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Quebec City, Quebec, Canada. 7. 7 Division of Respiratory and Critical Care Medicine, Queen's University, Kingston, Ontario, Canada. 8. 8 Department of Medicine, McMaster University, Hamilton, Ontario, Canada. 9. 9 Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada. 10. 10 Pulmonary Division, Department of Medicine, University of Alberta and G. F. MacDonald Centre for Lung Health, Covenant Health, Edmonton, Alberta, Canada. 11. 11 Department of Medicine, McGill University, Montreal, Quebec, Canada. 12. 12 Montreal Chest Institute, McGill University Health Centre, Montreal, Quebec, Canada. 13. 13 Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. 14. 14 Department of Medicine, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada; and. 15. 15 Royal Alexandra Hospital, Edmonton, Alberta, Canada.
Abstract
RATIONALE: Pulmonary rehabilitation improves dyspnea and exercise capacity in idiopathic pulmonary fibrosis (IPF); however, it is unknown whether breathing high amounts of oxygen during exercise training leads to further benefits. OBJECTIVES: Herein, we describe the design of the High Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated with Nintedanib study (the HOPE-IPF study). The primary objective of this study is to determine the physiological and perceptual impact of breathing high levels of oxygen during exercise training in patients with IPF who are receiving antifibrotic therapy. METHODS:HOPE-IPF is a two-arm double-blind multicenter randomized placebo-controlled trial of 88 patients with IPF treated with nintedanib. Patients will undergo 8 weeks of three times weekly aerobic cycle exercise training, breathing a hyperoxic gas mixture with a constant fraction of 60% inhaled oxygen, or breathing up to 40% oxygen as required to maintain an oxygen saturation level of at least 88%. MEASUREMENTS AND MAIN RESULTS: End points will be assessed at baseline, postintervention (Week 8), and follow-up (Week 26). The primary analysis will compare the between-group baseline with post-training change in endurance time during constant work rate cycle exercise tests. Additional analyses will evaluate the impact of training with high oxygen delivery on 6-minute walk distance, dyspnea, physical activity, and quality of life. CONCLUSIONS: The HOPE-IPF study will lead to a comprehensive understanding of IPF exercise physiology, with the potential to change clinical practice by indicating the need for increased delivery of supplemental oxygen during pulmonary rehabilitation in patients with IPF. Clinical trial registered with www.clinicaltrials.gov (NCT02551068).
RCT Entities:
RATIONALE: Pulmonary rehabilitation improves dyspnea and exercise capacity in idiopathic pulmonary fibrosis (IPF); however, it is unknown whether breathing high amounts of oxygen during exercise training leads to further benefits. OBJECTIVES: Herein, we describe the design of the High Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated with Nintedanib study (the HOPE-IPF study). The primary objective of this study is to determine the physiological and perceptual impact of breathing high levels of oxygen during exercise training in patients with IPF who are receiving antifibrotic therapy. METHODS: HOPE-IPF is a two-arm double-blind multicenter randomized placebo-controlled trial of 88 patients with IPF treated with nintedanib. Patients will undergo 8 weeks of three times weekly aerobic cycle exercise training, breathing a hyperoxic gas mixture with a constant fraction of 60% inhaled oxygen, or breathing up to 40% oxygen as required to maintain an oxygen saturation level of at least 88%. MEASUREMENTS AND MAIN RESULTS: End points will be assessed at baseline, postintervention (Week 8), and follow-up (Week 26). The primary analysis will compare the between-group baseline with post-training change in endurance time during constant work rate cycle exercise tests. Additional analyses will evaluate the impact of training with high oxygen delivery on 6-minute walk distance, dyspnea, physical activity, and quality of life. CONCLUSIONS: The HOPE-IPF study will lead to a comprehensive understanding of IPF exercise physiology, with the potential to change clinical practice by indicating the need for increased delivery of supplemental oxygen during pulmonary rehabilitation in patients with IPF. Clinical trial registered with www.clinicaltrials.gov (NCT02551068).
Authors: Diana Badenes-Bonet; Pilar Cejudo; Anna Rodó-Pin; Clara Martín-Ontiyuelo; Roberto Chalela; Jose Antonio Rodríguez-Portal; Rosa Vázquez-Sánchez; Joaquim Gea; Xavier Duran; Oswaldo Antonio Caguana; Diego Agustín Rodriguez-Chiaradia; Eva Balcells Journal: BMC Pulm Med Date: 2021-11-08 Impact factor: 3.317