Chronic Obstructive Pulmonary DiseaseNCT06174207
Hyperoxia During Pulmonary Rehabilitation in Chronic Lung Disease - Does it Matter?
A study testing Oxygen in people with Chronic Obstructive Pulmonary Disease and Asthma, run by Eastern Switzerland University of Applied Sciences at 1 site in Switzerland.
Trial summary
Chronic respiratory diseases are a global burden. Treatment options have improved in recent years, pulmonary rehabilitation plays a key role. Oxygen therapy is recommended in patients with a low saturation at rest, but no clear guidance is given for patients who desaturate during exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma, Pulmonary Hypertension
- What is being tested?
- Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Jan 2024to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will include male and female lung disease patients undergoing pulmonary rehabilitation: aged ≥ 18 years; stable condition > 3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% during a 6-minute walking test (6MWT); informed consent as documented by signature.
Who cannot join
- Severe daytime resting hypoxemia (SpO2 < 88% or partial pressure of oxygen (PaO2) < 8 kPa); unstable condition requiring adaptation of pharmacologic and other treatment modalities or requirement of intensive care or relevant severe concomitant disease; inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability or inability to ride a bicycle; women who are pregnant or breast feeding; enrolment in another clinical trial with active treatment.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8400
About this study
Chronic respiratory diseases are a global burden. Treatment options have improved in recent years, pulmonary rehabilitation plays a key role. Oxygen therapy is recommended in patients with a low saturation at rest, but no clear guidance is given for patients who desaturate during exercise. The effect of ambulatory oxygen during exercise is not yet completely understood, especially in those patients with exercise-induced desaturation.
Aim: The goal of this study is to analyse the effect of supplemental oxygen given during a constant work rate exercise test (CWRET) on a cycle ergometer compared to sham air.
Read more
Methods: We plan to include 25 Patients respiratory patients undergoing pulmonary rehabilitation (male and female; aged >18 years; stable condition >3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88%) with exercise induced hypoxemia defined by a fall in oxygen saturation by ≥ 4% during a 6-minute walking test. Patients will undergo an incremental exercise test with a ramp protocol (for evaluating the maximal workload) and two CWRET (75% of the maximal workload) with ambulatory oxygen or placebo (sham air) via standard nasal canula at a flow rate of 5l/min. Patients and assessors will be blinded. The difference endurance time of the CWRET with oxygen vs. sham air will be the primary outcome of this study.
Data will be summarized by means (SD) and medians (quartiles) for normal and non-normal distributions. Effects of treatment will be evaluated by mean differences with 95% confidence intervals, T-tests or Wilcoxon matched pair tests as appropriate. A p-value threshold of <0.05 or a confidence interval not including zero will be considered as statistically significant. Analyses will be performed according to the intention to treat principle.
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma, Pulmonary Hypertension, Interstitial Lung Disease, Chronic Lung Disease
- Being tested
- Oxygen
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Hypertension, Pulmonary, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenOther
Standard supplemental Oxygen therapy (5l/min) will be applied with an oxygen concentrator via nasal cannula.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Start with Constant Work Rate Exercise Test with 5l/min room air applied via nasal cannula. Receives: Other: Oxygen |
| Experimental Group | Experimental | Start with Constant Work Rate Exercise Test with 5l/min Oxygen Therapy applied via nasal cannula. Receives: Other: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Work Rate Exercise Test
Endurance time measured with Constant Work Rate Exercise Test (CWRET) (75% of the maximal work rate from the maximal ramp exercise test)
Measured: 7 days
Secondary outcomes (4)
SpO2
SpO2 by finger pulse oximetry, brain and muscle tissue oxygenation by near infrared spectroscopy (NIRS) at rest and end-exercise CWRET
Measured: 7 days
Heart Rate
Heart rate at rest and end-exercise CWRET
Measured: 7 days
Borg Scale (0-10)
Borg scale (dyspnoea and fatigue) at rest and end-exercise CWRET
Measured: 7 days
Blood Pressure
Blood pressure at rest and end-exercise CWRET
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start24 Jan 2024
- Primary completion1 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Switzerland University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, Kantonsspital Winterthur KSW
- Responsible party
- Sponsor
- Investigators
- Swantje Beyer, Dr.med., Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174207
- Sponsor's protocol ID
- RehaExO2
- Status last verified
- Aug 2025
- First submitted
- 8 Dec 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperoxia During Pulmonary Rehabilitation in Chronic Lung Disease - Does it Matter?
- ClinicalTrials.gov ID
- NCT06174207
- Acronym / sponsor ID
- RehaExO2
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma, Pulmonary Hypertension, Interstitial Lung Disease, Chronic Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Eastern Switzerland University of Applied SciencesUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, Kantonsspital Winterthur KSW
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic respiratory diseases are a global burden. Treatment options have improved in recent years, pulmonary rehabilitation plays a key role. Oxygen therapy is recommended in patients with a low saturation at rest, but no clear guidance is given for patients who desaturate during exercise. The effect of ambulatory oxygen during exercise is not yet completely understood, especially in those patients with exercise-induced desaturation.
Aim: The goal of this study is to analyse the effect of supplemental oxygen given during a constant work rate exercise test (CWRET) on a cycle ergometer compared to sham air.
Methods: We plan to include 25 Patients respiratory patients undergoing pulmonary rehabilitation (male and female; aged >18 years; stable condition >3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88%) with exercise induced hypoxemia defined by a fall in oxygen saturation by ≥ 4% during a 6-minute walking test. Patients will undergo an incremental exercise test with a ramp protocol (for evaluating the maximal workload) and two CWRET (75% of the maximal workload) with ambulatory oxygen or placebo (sham air) via standard nasal canula at a flow rate of 5l/min. Patients and assessors will be blinded. The difference endurance time of the CWRET with oxygen vs. sham air will be the primary outcome of this study.
Data will be summarized by means (SD) and medians (quartiles) for normal and non-normal distributions. Effects of treatment will be evaluated by mean differences with 95% confidence intervals, T-tests or Wilcoxon matched pair tests as appropriate. A p-value threshold of <0.05 or a confidence interval not including zero will be considered as statistically significant. Analyses will be performed according to the intention to treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: OxygenStart with Constant Work Rate Exercise Test with 5l/min room air applied via nasal cannula. |
| Experimental Group | Experimental | Other: OxygenStart with Constant Work Rate Exercise Test with 5l/min Oxygen Therapy applied via nasal cannula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We will include male and female lung disease patients undergoing pulmonary rehabilitation: aged ≥ 18 years; stable condition > 3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% during a 6-minute walking test (6MWT); informed consent as documented by signature.
Key exclusion criteria (1 listed)
- Severe daytime resting hypoxemia (SpO2 < 88% or partial pressure of oxygen (PaO2) < 8 kPa); unstable condition requiring adaptation of pharmacologic and other treatment modalities or requirement of intensive care or relevant severe concomitant disease; inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability or inability to ride a bicycle; women who are pregnant or breast feeding; enrolment in another clinical trial with active treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenStandard supplemental Oxygen therapy (5l/min) will be applied with an oxygen concentrator via nasal cannula. | Other | Experimental Group, Placebo Group |
Primary outcome
Constant Work Rate Exercise Test
Time frame: 7 days
Endurance time measured with Constant Work Rate Exercise Test (CWRET) (75% of the maximal work rate from the maximal ramp exercise test)
4 secondary outcomes
SpO2
Time frame: 7 days
Heart Rate
Time frame: 7 days
Borg Scale (0-10)
Time frame: 7 days
Blood Pressure
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swantje Beyer, Dr.med. principal investigator
Kantonsspital Winterthur KSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Chronic Obstructive Pulmonary Disease and Asthma, run by Eastern Switzerland University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Work Rate Exercise Test (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.