Interstitial Lung Disease
Conditions
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.
Interventions
PROCEDUREIncremental exercise test (IET)
Incremental cardio pulmonary exercise test until exhaustion
PROCEDUREConstant work rate exercise test (CWRET)
constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work Rate (in watts) | 1 day | Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests |
| Endurance time (in seconds) | 1 day | Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in breathing patterns: Minute ventilation (VE) | 1 day | VE (in liters per minute) |
| Changes breathing patterns: Tidal volume (Vt) | 1 day | Vt (in liters) |
| Changes in breathing patterns: Oxygen uptake (VO2) | 1 day | VO2 (in liters per minute) |
| Changes in breathing patterns: Carbon dioxide output (VCO2) | 1 day | VCO2 (in liters per minute) |
| Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2) | 1 day | ratio between minute ventilation and oxygen uptake |
| Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2) | 1 day | ratio between minute ventilation and carbon dioxide output |
| Changes in breathing patterns: VE/VCO2Slope | 1 day | Ratio between minute ventilation and carbon dioxide output if carbon dioxide reaches the breathing plateau |
| Changes in breathing patterns: Ventilatory threshold one (Vt1) | 1 day | represents the start of anaerobic metabolism |
| changes in physiological vital signs: Heart rate (hr) | 1 day | Hr (in beats per minute) |
| Changes in arterial blood: arterial partial pressure of O2 (PaO2) | 1 day | PaO2 (in kPa) |
| Changes in arterial blood: arterial partial pressure of CO2 (PaCO2) | 1 day | PaCO2 (in kPa) |
| Changes in arterial blood: arterial lactate concentration | 1 day | lactate concentration (in mmol per liter) |
| Changes in arterial blood: pondus Hydrogenii (pH) values | 1 day | pH (1-14) |
| Changes in arterial blood: Bicarbonate (HCO3) | 1 day | HCO3 (in mmol per liter) |
| Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger) | 1 day | SpO2 (in percent) |
| Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead) | 1 day | CTO (in percent) |
| Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle) | 1 day | MTO (in percent) |
| Changes in breathing patterns: Ventilatory threshold two (Vt2) | 1 day | represents the start of higher percentage of the anaerobic metabolism |
| changes in physiological vital signs: Blood pressure | 1 day | Systolic and diastolic blood pressure (in mmHg) |
Countries
Switzerland
Contacts
Primary ContactSilvia Ulrich, Prof. Dr.
Outcome results
None listed