Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy With Chronic Lung Diseases

NCT ID: NCT06385301

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-07-01

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.

Conditions

Lung Disease Chronic; Lung Diseases, Interstitial; Lung Diseases, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ambient air

Patient will perform tests at University Hospital Zurich on ambient air

Group Type: EXPERIMENTAL

6-minute walk distance (6MWD) test on ambient air

Intervention Type: OTHER

6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards

SOT via basal cannula

Supplemental Oxygen Therapy (SOT) will be provided via nasal cannula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich.

Group Type: ACTIVE_COMPARATOR

6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal)

Intervention Type: OTHER

6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (approximately 3l/min, nasal)

Interventions

6-minute walk distance (6MWD) test on ambient air

6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards

Intervention Type: OTHER

6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal)

6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (approximately 3l/min, nasal)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Ulrich, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Pulmonology

Locations

University Hospital Zürich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

Lung_disease_6MWD_SOT

Identifier Type: -

Identifier Source: org_study_id