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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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.
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 Unpublished data suggest that breathing 60% oxygen in a pulmonary rehabilitation setting could enable patients to train at higher exercise intensities and thus derive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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60% Oxgyen | Experimental | While participants are exercising, they will be breathing 60% oxygen through a mask. |
|
| Standard of Care | Placebo Comparator | 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 60% Oxygen | Other | While participants are exercising, they will be inhaling 60% oxygen through a mask |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Ryerson, MD | St. Paul's Hospital | Principal Investigator |
| Jordan Guenette, PhD | St. Paul's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T3M1M4 | Canada | ||
| University of Alberta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27348402 | Derived | 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. |
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| Standard of Care | Other | 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%. |
|
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 |
| Edmonton |
| Alberta |
| T6G 2R3 |
| Canada |
| UBC Okanagan | Kelowna | British Columbia | V1V 1V7 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z1Y6 | Canada |
| McMaster University | Hamilton | Ontario | L8S 4L8 | Canada |
| Queens University | Kingston | Ontario | K7L 3N6 | Canada |
| McGill University | Montreal | Quebec | H3A 0G4 | Canada |
| Laval University | Québec | Quebec | G1V 0A6 | Canada |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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