Effect of Short-term Oxygen During CPET in ILD

University of Zurich (UZH)

Status: Not yet enrolling

Conditions: Interstitial Lung Disease

Treatments: Procedure: Constant work rate exercise test (CWRET); Procedure: Incremental exercise test (IET)

Study type: Interventional

Funder types: Other

Identifiers

NCT04897048

KEK-ZH-NR. 2012-0251_5

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Oxygen

Experimental group

Description:

Supplemental oxygen will be applied via a mask during CPET

Treatment:

Procedure: Constant work rate exercise test (CWRET)

Procedure: Incremental exercise test (IET)

Air

Sham Comparator group

Description:

Sham ambient air will be applied via mask during CPET

Treatment:

Procedure: Constant work rate exercise test (CWRET)

Procedure: Incremental exercise test (IET)