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

NCT06385301 | Completed

• 1 other identifier: Lung_disease_6MWD_SOT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Supplemental Oxygen Therapy; 6 Minute Walking Distance; Chronic lung diseases

Outcome Measures

Primary Outcomes (1)

• 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air

  Change in 6MWD in meter between SOT via nasal cannula vs. ambient air

  after 6 minutes

Secondary Outcomes (5)

• SpO2 at rest and peak 6MWD with SOT vs. ambient air

  after 6 minutes

• Heart rate at rest and peak 6MWD with SOT vs. ambient air

  after 6 minutes

• Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air

  6 minutes

• Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air

  after 6 minutes

• Blood pressure at rest and peak 6MWD with SOT vs. ambient air

  after 6 minutes

Study Arms (2)

Ambient air

EXPERIMENTAL

Patient will perform tests at University Hospital Zurich on ambient air

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

SOT via basal cannula

ACTIVE COMPARATOR

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

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

Interventions

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

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

Ambient air

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

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

SOT via basal cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Silvia Ulrich, Prof. Dr.

  University Hospital Zurich, Department of Pulmonology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant is its own control

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)