Exercise Performance on Ambient Air Vs. Low-Flow Oxygen Therapy with Chronic Lung Diseases

Not Applicable

Recruiting

• Conditions: Lung Disease Chronic; Lung Diseases, Obstructive; Lung Diseases, Interstitial
• Interventions: Other: 6-minute walk distance (6MWD) test on ambient air; Other: 6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal)

• Registration Number: NCT06385301
• Lead Sponsor: University of Zurich

Brief Summary

The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise.

Detailed Description

Participants with lung disease who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT at approximately 3l/min via nasal cannula according to a randomized cross-over design.

The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.

Our effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.

Study Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-26
• Study Start: 2024-05-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Minimum 18 years of age
• Written informed consent
• Patients with diagnosed chronic lung disease
• Former desaturation under exercise defined as Spo2-decrease >3%- Page 3 of 4
• Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)

Exclusion Criteria

• Severe hypoxemia needing supplemental oxygen therapy defined as (partial pressure of Oxygen (PaO2) < 6.9 KiloPascal (kPa)
• Pregnancy
• Unability or contraindications to undergo the investigated intervention
• Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ambient air	6-minute walk distance (6MWD) test on ambient air	Patient will perform tests at University Hospital Zurich on ambient air
SOT via basal cannula	6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal)	Supplemental Oxygen Therapy (SOT) will be provided via nasal cannula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich.

Primary Outcome Measures

Name	Time	Method
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air	after 6 minutes	Change in 6MWD in meter between SOT via nasal cannula vs. ambient air

Secondary Outcome Measures

Name	Time	Method
Blood pressure at rest and peak 6MWD with SOT vs. ambient air	after 6 minutes	Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT vs. ambient air
SpO2 at rest and peak 6MWD with SOT vs. ambient air	after 6 minutes	Change of the arterial oxygen saturation by pulse oximetry (SpO2) at rest and at peak 6MWD with SOT vs. ambient air
Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air	6 minutes	Change of Borg dyspnea scale at rest and at peak 6MWD with SOT vs. ambient air
Heart rate at rest and peak 6MWD with SOT vs. ambient air	after 6 minutes	Change of heart rate (bpm) at rest and at peak 6MWD with SOT vs. ambient air
Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air	after 6 minutes	Change of Borg leg fatigue scale at rest and at peak 6MWD with SOT vs. ambient air

Trial Locations

Locations (1)

University Hospital Zürich; 🇨🇭 Zurich, Switzerland