High Oxygen Delivery to Preserve Exercise Capacity in Idiopathic Pulmonary Fibrosis Patients Treated With Nintedanib (HOPE-IPF)

High Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated With Nintedanib: The HOPE-IPF Study

The purpose is to determine if patients with idiopathic pulmonary fibrosis (IPF) taking nintedanib will have improved exercise endurance, breathlessness and quality of life if breathing 60% oxygen compared to standard of care during an 8 week exercise training program.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Other: 60% Oxygen; Other: Standard of Care

Detailed Description

Pulmonary rehabilitation is a structured evidence-based exercise and education intervention that is recommended for most patients with IPF. Pulmonary rehabilitation improves functional capacity (6-minute walk distance [6MWD]), breathlessness and quality of life in patients, however these benefits are often modest and only temporary. Nintedanib is an antifibrotic medication that has been shown to slow the decline of lung function. Use of antifibrotic medications in the pulmonary rehabilitation setting may therefore allow prolonged benefit of exercise training by preventing IPF progression and the resulting worsening symptoms and functional decline. Unpublished data suggest that breathing 60% oxygen in a pulmonary rehabilitation setting could enable patients to train at higher exercise intensities and thus derive greater physiological adaptations and clinical benefits compared with traditional pulmonary rehabilitation.

This is a randomized, blinded study with two arms (standard of care or 60% oxygen). The decision to start or stop treatment with nintedanib will be made by the participants treating physician based on clinical findings. If the treating physician decides to discontinue nintedanib, the participant will be allowed to continue in the study.

The exercise training program is 8 weeks long, with visits 3 times a week. In addition to the exercise training there are 13 visits occurring before, during and after the 8 week exercise training program. At study visits, participants will be required to conduct a 6 minute walk test and complete a quality of life questionnaire. Select study visits will also require lung function tests and exercise tests to be conducted.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3M1M4
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2R3
      • University of Alberta
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 1V7
      • UBC Okanagan
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • St. Paul's Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4L8
      • McMaster University
    • Kingston, Ontario, Canada, K7L 3N6
      • Queens University
  • Quebec
    • Montreal, Quebec, Canada, H3A 0G4
      • McGill University
    • Québec, Quebec, Canada, G1V 0A6
      • Laval University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 19 years or older
• Idiopathic Pulmonary Fibrosis (IPF) diagnosis according to American Thoracic Society and/or European Respiratory Society consensus criteria
• Appropriate candidate for pulmonary rehabilitation
• prescribed nintedanib by their treating physician or currently on nintedanib
• 6 minute walk distance 50m or more
• Oxygen saturation 92% or more by pulse oximetry at rest while breathing room air
• Clinically stable for the preceding 6 weeks

Exclusion Criteria:

• Contraindication to treatment with nintedanib (based on Canadian labeling)
• Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
• Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
• Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
• Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
• Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
• Use of pirfenidone within 4 weeks of screening
• Significant emphysema (less than 10% volume on high resolution computed tomography (HRCT) or forced expiratory volume at one second (FEV1)/FVC less than 0.70)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 60% Oxgyen; While participants are exercising, they will be breathing 60% oxygen through a mask.	Other: 60% Oxygen; While participants are exercising, they will be inhaling 60% oxygen through a mask
Placebo Comparator: Standard of Care; While participants are exercising, they will be breathing air through a mask that will be titrated to keep oxygen saturation at least 88%, allowing a maximum inhaled oxygen percentage of 40%.	Other: Standard of Care; While participants are exercising, they will be breathing air through a mask that will be titrated to keep oxygen saturation at least 88%, allowing a maximum inhaled oxygen percentage of 40%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in exercise duration during the constant load exercise test at 8 weeks	An constant load exercise test on a stationary bike will be performed. Patients will be told to exercise for as long as possible and endurance time will be defined as the duration of the constant load exercise test.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6 Minute Walk Distance (6MWD) at 8 weeks	Patients will be asked to walk, at their own pace, as far as they can in 6 minutes.	8 weeks
Change in the amount a patient is troubled by their breathlessness at 8 weeks	Measured using the modified Medical Research Council dyspnea scale (mMRC)	8 weeks
Change in the amount a patient is troubled by their breathlessness during the 6 Minute Walk Distance test at 8 weeks	Measured using the 10-point Borg scale during 6MWD	8 weeks
Change in the amount a patient is troubled by their breathlessness during the cycle exercise test at 8 weeks	Measured using the 10-point Borg scale during cycle exercise tests	8 weeks
Change in how much shortness of breath the patient experiences while doing normal activities at 8 weeks	Measured using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ).	8 weeks
Change in the amount of physical work a patient can do before becoming breathless at 8 weeks	Measured using the oxygen cost diagram (OCD).	8 weeks
Patient reported change in amount of physical activity at 8 weeks	Physical activity will be measured using the long form of the international physical activity questionnaire (IPAQ-LF).	8 weeks
Change in amount of physical activity at 8 weeks	Physical activity will be measured objectively using the Fit Bit activity monitor.	8 weeks
Change in Quality of Life at 8 weeks	Disease-specific quality of life will be measured using the St. George's Respiratory Questionnaire (SGRQ).	8 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Chris Ryerson, MD, St. Paul's Hospital; Principal Investigator: Jordan Guenette, PhD, St. Paul's Hospital

Publications and helpful links

General Publications

• Ryerson CJ, Camp PG, Eves ND, Schaeffer M, Syed N, Dhillon S, Jensen D, Maltais F, O'Donnell DE, Raghavan N, Roman M, Stickland MK, Assayag D, Bourbeau J, Dion G, Fell CD, Hambly N, Johannson KA, Kalluri M, Khalil N, Kolb M, Manganas H, Moran-Mendoza O, Provencher S, Ramesh W, Rolf JD, Wilcox PG, Guenette JA. High Oxygen Delivery to Preserve Exercise Capacity in Patients with Idiopathic Pulmonary Fibrosis Treated with Nintedanib. Methodology of the HOPE-IPF Study. Ann Am Thorac Soc. 2016 Sep;13(9):1640-7. doi: 10.1513/AnnalsATS.201604-267OC.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimated): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Inorganic Chemicals; Elements; Chalcogens; Gases; Standard of Care; Oxygen
• Other Study ID Numbers: H15-01200