Effect of Short-term Oxygen During CPET in ILD

Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Interstitial Lung Disease (ILD)

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 Overview

• Status: Not yet recruiting
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Procedure: Incremental exercise test (IET); Procedure: Constant work rate exercise test (CWRET)

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Respiratory Clinic, University Hospital of Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxygen; Supplemental oxygen will be applied via a mask during CPET	Procedure: Incremental exercise test (IET); Incremental cardio pulmonary exercise test until exhaustion; Procedure: Constant work rate exercise test (CWRET); constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion
Sham Comparator: Air; Sham ambient air will be applied via mask during CPET	Procedure: Incremental exercise test (IET); Incremental cardio pulmonary exercise test until exhaustion; Procedure: Constant work rate exercise test (CWRET); constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work Rate (in watts)	Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests	1 day
Endurance time (in seconds)	Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in physiological vital signs: Heart rate (hr)	Hr (in beats per minute)	1 day
changes in physiological vital signs: Blood pressure	Systolic and diastolic blood pressure (in mmHg)	1 day
Changes in breathing patterns: Minute ventilation (VE)	VE (in liters per minute)	1 day
Changes breathing patterns: Tidal volume (Vt)	Vt (in liters)	1 day
Changes in breathing patterns: Oxygen uptake (VO2)	VO2 (in liters per minute)	1 day
Changes in breathing patterns: Carbon dioxide output (VCO2)	VCO2 (in liters per minute)	1 day
Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)	ratio between minute ventilation and oxygen uptake	1 day
Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2)	ratio between minute ventilation and carbon dioxide output	1 day
Changes in breathing patterns: VE/VCO2Slope	Ratio between minute ventilation and carbon dioxide output if carbon dioxide reaches the breathing plateau	1 day
Changes in breathing patterns: Ventilatory threshold one (Vt1)	represents the start of anaerobic metabolism	1 day
Changes in breathing patterns: Ventilatory threshold two (Vt2)	represents the start of higher percentage of the anaerobic metabolism	1 day
Changes in arterial blood: arterial partial pressure of O2 (PaO2)	PaO2 (in kPa)	1 day
Changes in arterial blood: arterial partial pressure of CO2 (PaCO2)	PaCO2 (in kPa)	1 day
Changes in arterial blood: arterial lactate concentration	lactate concentration (in mmol per liter)	1 day
Changes in arterial blood: pondus Hydrogenii (pH) values	pH (1-14)	1 day
Changes in arterial blood: Bicarbonate (HCO3)	HCO3 (in mmol per liter)	1 day
Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger)	SpO2 (in percent)	1 day
Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead)	CTO (in percent)	1 day
Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle)	MTO (in percent)	1 day

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: May 9, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: KEK-ZH-NR. 2012-0251_5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No