NCT04897048
Not yet recruiting
Not Applicable
Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Interstitial Lung Disease (ILD)
ConditionsInterstitial Lung Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Interstitial Lung Disease
- Sponsor
- University of Zurich
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Work Rate (in watts)
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with interstitial lung disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •interstitial lung disease, diagnosed by high-resolution CT
- •FEV1/FVC \>70% and FVC \<85% predicted
- •stable medication for at least 4 weeks
- •Desaturation in SpO2 in 6-minute walk test of ≥ 4% to absolute values ≤ 92%
- •Signed Informed Consent
- •Male and female patients 18 to 80 years of age
Exclusion Criteria
- •Severe daytime hypoxemia (PaO2 ≤7.3 or \<55 mmHg at rest)
- •Other clinically significant concomitant disease states (e.g., cardiovascular disease, hepatic dysfunction, etc)
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject, neurological or orthopaedic problems with walking disability or inability to ride a bicycle
- •Women who are pregnant or breast feeding
Outcomes
Primary Outcomes
Work Rate (in watts)
Time Frame: 1 day
Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests
Endurance time (in seconds)
Time Frame: 1 day
Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests
Secondary Outcomes
- Changes in arterial blood: Bicarbonate (HCO3)(1 day)
- Changes in breathing patterns: Oxygen uptake (VO2)(1 day)
- Changes in arterial blood: pondus Hydrogenii (pH) values(1 day)
- changes in physiological vital signs: Heart rate (hr)(1 day)
- Changes in breathing patterns: Carbon dioxide output (VCO2)(1 day)
- Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)(1 day)
- Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2)(1 day)
- Changes in breathing patterns: VE/VCO2Slope(1 day)
- Changes in breathing patterns: Ventilatory threshold one (Vt1)(1 day)
- Changes in breathing patterns: Minute ventilation (VE)(1 day)
- Changes breathing patterns: Tidal volume (Vt)(1 day)
- changes in physiological vital signs: Blood pressure(1 day)
- Changes in arterial blood: arterial partial pressure of CO2 (PaCO2)(1 day)
- Changes in breathing patterns: Ventilatory threshold two (Vt2)(1 day)
- Changes in arterial blood: arterial partial pressure of O2 (PaO2)(1 day)
- Changes in arterial blood: arterial lactate concentration(1 day)
- Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead)(1 day)
- Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger)(1 day)
- Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle)(1 day)
Study Sites (1)
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