"G. Papanikolaou" General Hospital
Thessaloniki, 57010, Greece
NCT Number: NCT03688334
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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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Thessaloniki, 57010, Greece
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxygen supplementation (40%) via Venturi mask
Medical air supplementation via Venturi mask
Time frame: through study completion, an average of a year
Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion
Time frame: through study completion, an average of a year
maximum dyspnea assessed with modified Borg dyspnea scale (range from 0: nothing at all to 10: maximum dyspnea), during steady state cardiopulmonary exercise testing
Time frame: through study completion, an average of a year
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
Time frame: through study completion, an average of a year
The minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing
Time frame: through study completion, an average of a year
The maximum value of cardiac output in L/min during steady state cardiopulmonary exercise testing
George Papanicolaou Hospital
Other
Acute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting Hypoxemia
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