High Oxygen Delivery to Preserve Exercise Capacity in Patients with Idiopathic Pulmonary Fibrosis Treated with Nintedanib. Methodology of the HOPE-IPF Study

Autor: Pearce G. Wilcox, Warren Ramesh, Dennis Jensen, Natya Raghavan, Michael A. Roman, Hélène Manganas, Jean Bourbeau, Nasreen Khalil, Neil D. Eves, Satvir S. Dhillon, Michele R. Schaeffer, Geneviève Dion, Charlene D. Fell, Nathan Hambly, Kerri A. Johannson, Jordan A. Guenette, Nafeez Syed, Martin Kolb, Pat G. Camp, Michael K. Stickland, J. Douglass Rolf, Onofre Moran-Mendoza, Meena Kalluri, S. Provencher, Christopher J. Ryerson, Deborah Assayag, Denis E. O'Donnell, François Maltais
Rok vydání: 2016
Předmět:
Adult
Male
Pulmonary and Respiratory Medicine
Canada
medicine.medical_specialty
Indoles
medicine.medical_treatment
Vital Capacity
chemistry.chemical_element
Oxygen
Young Adult
03 medical and health sciences
Idiopathic pulmonary fibrosis
chemistry.chemical_compound
0302 clinical medicine
Double-Blind Method
High oxygen
Internal medicine
medicine
Humans
Pulmonary rehabilitation
030212 general & internal medicine
Intensive care medicine
Aged
Exercise Tolerance
business.industry
Interstitial lung disease
Middle Aged
respiratory system
Exercise capacity
medicine.disease
Idiopathic Pulmonary Fibrosis
Exercise Therapy
respiratory tract diseases
Dyspnea
Treatment Outcome
030228 respiratory system
chemistry
Research Design
Exercise Test
Quality of Life
Breathing
Cardiology
Female
Nintedanib
business
Zdroj: Annals of the American Thoracic Society. 13:1640-1647
ISSN: 2325-6621
2329-6933
Popis: 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.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.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%.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.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).
Databáze: OpenAIRE