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CompletedNCT06384534Updated Dec 10, 2025

Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)

An interventional study of 6-minute walk distance (6MWD) test on ambient air and 6-minute walk distance test with supplemental oxygen in Pulmonary Vascular Disorder, Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by University of Zurich · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).

Read the detailed description

Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT 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.

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

02

Conditions studied

  • Pulmonary Vascular Disorder
  • Chronic Thromboembolic Pulmonary Hypertension
  • Pulmonary Arterial Hypertension

Keywords

  • Pulmonary Hypertension
  • Supplemental Oxygen Therapy
  • Pulmonary Arterial Hypertension
  • Chronic Thromboembolic Pulmonary Hypertension
  • Pulmonary Vascular Disease
  • 6 Minute Walking Distance
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 40 is close to the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Minimum 18 years of age
  • Written informed consent
  • Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH)
  • Former desaturation under exercise defined as Spo2-decrease >3%
  • Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)

Exclusion criteria

Exclusion Criteria:

  • Severe hypoxemia needing supplemental oxygen therapy defined as partial pressure of O2 (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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Ambient air

    Patient will perform tests at University Hospital Zurich

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

  • Active comparator
    SOT via basal canula

    Supplemental Oxygen Therapy (SOT) at approximately 3l/min will be provided via nasal canula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich.

    Other: 6-minute walk distance test with supplemental oxygen

Interventions

  • Other6-minute walk distance (6MWD) test on ambient air

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

  • Other6-minute walk distance test with supplemental oxygen

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

06

What researchers measure

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

    Time frame: after 6 minutes

Secondary outcomes

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

    Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with SOT approximately 3l /min vs. ambient air

    Time frame: after 6 minutes

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

    Change of heart rate (bpm) at rest and at peak 6MWD with SOT vs. ambient air

    Time frame: after 6 minutes

  3. Borg dyspnea atrest and peak 6MWD with SOT vs. ambient air

    Change of Borg dyspnea scale (CR10, 0-10 where 10 is the worst dyspnea) at rest and at peak 6MWD with SOT vs. ambient air

    Time frame: 6 minutes

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

    Change of Borg leg fatigue scale (CR10, 0-10 where 10 is the strongest led fatugue) at rest and at peak 6MWD with SOT vs. ambient air

    Time frame: 6 minutes

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

    Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT vs. ambient air

    Time frame: after 6 minutes

07

Study locations

1 site
  • University Hospital Zürich
    Zurich, Canton of Zurich 8091, Switzerland
08

References and documents

Individual participant data

Plan to share: Yes — Data will be provided upon request and based on a clear intention reviewed by an ethical review board

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06384534
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Apr 25, 2024
Start date
Apr 1, 2024
Primary completion
Jul 1, 2025
Completion
Jul 1, 2025
Last update
Dec 10, 2025

Study contacts

Silvia Ulrich, Prof. Dr.
principal investigator · University Hospital Zurich, Department of Pulmonology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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