Effect of Short-term Oxygen During CPET in ILD

University of Zurich10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Interstitial Lung Disease

Interventions

Incremental exercise test (IET)PROCEDURE

Incremental cardio pulmonary exercise test until exhaustion

Constant work rate exercise test (CWRET)PROCEDURE

constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Work Rate (in watts)

Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests

Time frame: 1 day

Endurance time (in seconds)

Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests

Time frame: 1 day

Secondary Outcomes

changes in physiological vital signs: Heart rate (hr)

Hr (in beats per minute)

Time frame: 1 day

changes in physiological vital signs: Blood pressure

Systolic and diastolic blood pressure (in mmHg)

Time frame: 1 day

Changes in breathing patterns: Minute ventilation (VE)

VE (in liters per minute)

Time frame: 1 day

Changes breathing patterns: Tidal volume (Vt)

Vt (in liters)

Time frame: 1 day

Changes in breathing patterns: Oxygen uptake (VO2)

VO2 (in liters per minute)

Time frame: 1 day

Changes in breathing patterns: Carbon dioxide output (VCO2)

VCO2 (in liters per minute)

Time frame: 1 day

Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)

Central Contacts

Silvia Ulrich, Prof. Dr.

CONTACT

+41442552220 silvia.ulrich@usz.ch

Data from ClinicalTrials.gov

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