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

University of Zurich (UZH)

Status: Completed

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

Treatments: Other: 6-minute walk distance (6MWD) test on ambient air; Other: 6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal)

Study type: Interventional

Funder types: Other

Identifiers

NCT06385301

Lung_disease_6MWD_SOT

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Ambient air

Experimental group

Description:

Patient will perform tests at University Hospital Zurich on ambient air

Treatment:

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

SOT via basal cannula

Active Comparator group

Description:

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

Treatment:

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