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Idiopathic pulmonary fibrosis (IPF) is a disease characterised with significant morbidity and poor prognosis. Dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. Although hypoxemia is common among subjects with IPF, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial.
Based on the aforementioned, the purpose of this prospective, cross-over clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with IPF, without resting hypoxemia, during steady state cardiopulmonary exercise testing (CPET).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPF patients | Active Comparator | Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing |
|
| IPF patients (crossover) | Sham Comparator | Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen 40 % | Drug | Oxygen supplementation (40%) via Venturi mask |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise duration | Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion | through study completion, an average of a year |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea | maximum dyspnea assessed with modified Borg dyspnea scale (range from 0: nothing at all to 10: maximum dyspnea), during steady state cardiopulmonary exercise testing | through study completion, an average of a year |
| Fatigue |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral oxygenated hemoglobin | The minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing | through study completion, an average of a year |
| Cardiac output |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aikaterini Markopoulou, MD, PhD | "G. Papanikolaou" General Hospital, Thessaloniki, Greece | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "G. Papanikolaou" General Hospital | Thessaloniki | 57010 | Greece |
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| 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 |
|---|---|
| D000388 | Air |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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| Medical air (sham O2) |
| Drug |
Medical air supplementation via Venturi mask |
|
maximum fatigue assessed by Borg's Rating of Perceived Exertion Scale (range from 6: no exertion to 20: maximal exertion), during steady state cardiopulmonary exercise testing
| through study completion, an average of a year |
The maximum value of cardiac output in L/min during steady state cardiopulmonary exercise testing
| through study completion, an average of a year |
| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |