Chronic Obstructive Pulmonary Disease (COPD)NCT06776731
Hyperoxia During Outpatient Pulmonary Rehabilitation in Chronic Lung Disease - Does it Matter?
A study testing Oxygen in people with Chronic Obstructive Pulmonary Disease (COPD), run by Eastern Switzerland University of Applied Sciences at 1 site in Switzerland.
Trial summary
Chronic obstructive pulmonary disease (COPD) is 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 (COPD)
- What is being tested?
- Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jan 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 with a confirmed diagnosis of COPD (post-bronchodilator forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) ratio of <0.7; a greater than 10 pack-year smoking history)
- undergoing pulmonary rehabilitation
- aged ≥ 18 years
- stable condition > 3 weeks (e.g. no exacerbations)
- resting oxygen saturation (SpO2) ≥ 88%
- exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% and/ or below 90% during a 6MWT
- informed consent as documented by signature.
Who cannot join
- Severe daytime resting hypoxemia (SpO2 < 88% )
- long-term oxygen therapy, 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. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8400
Spencer Rezek, PhD cand., +41754383867, spencer.rezek@ksw.ch
About this study
Chronic obstructive pulmonary disease (COPD) is 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: Evaluate the effect of supplemental oxygen therapy during a 3-months long ambulatory pulmonary rehabilitation program on exercise endurance. Patients will either receive supplemental oxygen therapy or room air during exercise training.
Read more
Methods: A total of 32 patients with a confirmed diagnosis of COPD undergoing pulmonary rehabilitation will be included (male and female : 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% and/ or below 90% during a 6-minute walking test). 3-months comprehensive PR for both intervention and control group including: education and awareness, instruction on inhalation therapies, smoking cessation counselling, respiratory and skeletal muscle training in groups, guided walks / cycle ergometer training. The intervention group will be trained using SSOT and the control group will receive sham air (ambient air). Patients and assessors will be blinded. Between group difference in cycling constant work rate exercise test (CWRET) time from baseline to 3 months SSOT (5l/min) vs ambient 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.
- Being tested
- Oxygen, Room Air (placebo)
- Keywords
- COPD, oxygen therapy, pulmonary rehabilitation, hyperoxia, exercise medicine
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hyperoxia
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 during endurance training.
Room Air (placebo)Other
Room air (5l/min) will be applied with an oxygen concentrator via nasal cannula during endurance training.
| Study group | Role | What they receive |
|---|---|---|
| Endurance training with 5l/ min room air applied via nasal cannula. | Placebo comparator | Endurance training with 5l/ min room air applied via nasal cannula with an Everflo oxygen concentrator. Receives: Other: Room Air (placebo) |
| Endurance training with 5l/ min Oxygen Therapy applied via nasal cannula. | Experimental | Endurance training with 5l/ min Oxygen Therapy applied via nasal cannula with an Everflo oxygen concentrator.. 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
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: 3 months
Secondary outcomes (5)
6 minute walk test (6MWT)
6 minute walk distance (6MWD), SpO2 and heart rate at the end of the 6 minute walk test (6MWT) from baseline to 3 months at SSOT vs ambient air
Measured: 3 months
SpO2
SpO2 by finger pulse oximetry, brain and muscle tissue oxygenation by NIRS at rest and end-exercise CWRET from baseline to 3 months at SSOT vs ambient air
Measured: 3 months
Heart rate
Heart rate at rest and end-exercise CWRET from baseline to 3 months at SSOT vs ambient air
Measured: 3 months
Borg scale
Borg scale (Dyspnoea and fatigue) at rest and end-exercise CWRET from baseline to 3 months at SSOT vs ambient air. Measure of perceived exertion from 1-10, ranges from 1 (very light exertion) to 10 (maximum exertion).
Measured: 3 months
Constant Work Rate Exercise Test Endurance time
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: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start6 Jan 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Parallel groups
- Model description
- Randomised, multicentre, double-blinded, sham-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
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
- Silvia Ulrich, Prof., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776731
- Sponsor's protocol ID
- outRehaExO2
- Status last verified
- Sep 2026
- First submitted
- 16 Dec 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon request through the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperoxia During Outpatient Pulmonary Rehabilitation in Chronic Lung Disease - Does it Matter?
- ClinicalTrials.gov ID
- NCT06776731
- Acronym / sponsor ID
- outRehaExO2
- Keywords
- COPD, oxygen therapy, pulmonary rehabilitation, hyperoxia, exercise medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Eastern Switzerland University of Applied SciencesUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, Kantonsspital Winterthur KSW
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 15 Jan 2025 (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 obstructive pulmonary disease (COPD) is 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: Evaluate the effect of supplemental oxygen therapy during a 3-months long ambulatory pulmonary rehabilitation program on exercise endurance. Patients will either receive supplemental oxygen therapy or room air during exercise training.
Methods: A total of 32 patients with a confirmed diagnosis of COPD undergoing pulmonary rehabilitation will be included (male and female : 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% and/ or below 90% during a 6-minute walking test). 3-months comprehensive PR for both intervention and control group including: education and awareness, instruction on inhalation therapies, smoking cessation counselling, respiratory and skeletal muscle training in groups, guided walks / cycle ergometer training. The intervention group will be trained using SSOT and the control group will receive sham air (ambient air). Patients and assessors will be blinded. Between group difference in cycling constant work rate exercise test (CWRET) time from baseline to 3 months SSOT (5l/min) vs ambient 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
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomised, multicentre, double-blinded, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Endurance training with 5l/ min room air applied via nasal cannula. | Placebo comparator | Other: Room Air (placebo)Endurance training with 5l/ min room air applied via nasal cannula with an Everflo oxygen concentrator. |
| Endurance training with 5l/ min Oxygen Therapy applied via nasal cannula. | Experimental | Other: OxygenEndurance training with 5l/ min Oxygen Therapy applied via nasal cannula with an Everflo oxygen concentrator.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- We will include male and female with a confirmed diagnosis of COPD (post-bronchodilator forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) ratio of <0.7; a greater than 10 pack-year smoking history)
- undergoing pulmonary rehabilitation
- aged ≥ 18 years
- stable condition > 3 weeks (e.g. no exacerbations)
- resting oxygen saturation (SpO2) ≥ 88%
Key exclusion criteria (4 listed)
- Severe daytime resting hypoxemia (SpO2 < 88% )
- long-term oxygen therapy, 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 during endurance training. | Other | Endurance training with 5l/ min Oxygen Therapy applied via nasal cannula. |
| Room Air (placebo)Room air (5l/min) will be applied with an oxygen concentrator via nasal cannula during endurance training. | Other | Endurance training with 5l/ min room air applied via nasal cannula. |
Primary outcome
Constant Work Rate Exercise Test Endurance time
Time frame: 3 months
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)
5 secondary outcomes
6 minute walk test (6MWT)
Time frame: 3 months
SpO2
Time frame: 3 months
Heart rate
Time frame: 3 months
Borg scale
Time frame: 3 months
Constant Work Rate Exercise Test Endurance time
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be made available upon request through the corresponding author
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Silvia Ulrich, Prof. principal investigator
University of Zurich
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 (COPD), 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie Saxer, PHD (+41 58 257 12 97, stephanie.saxer@ost.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Work Rate Exercise Test Endurance time (time frame: 3 months). 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 10 Sep 2026.