COPDNCT07044843
Oxygen Therapy During Exercise Training in Inpatient Rehabilitation in Chronic Lung Disease- Does it Matter?
A study testing Oxygen and Standard ambiant air will be breathed during endurance training. in people with COPD, run by Eastern Switzerland University of Applied Sciences at 2 sites in 2 countries.
Trial summary
The aim of the current study is the effect of SSOT during a 3-weeks inpatient pulmonary rehabilitation program. Further aim is to analyze exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at approx. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Oxygen and Standard ambiant air will be breathed during endurance training.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Jul 2025to 23 Dec 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
- aged ≥ 18 years
- stable condition > 3 weeks (e.g. no exacerbations)
- resting SpO2 ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% and/or below 90% during a 6-minute walk test (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
2 sites in 2 countries.
2 sites in 2 countries
Kyrgyzstan1 site
National center for cardiology and internal medicine
Bishkek
Switzerland1 site
Eastern Switzerland University of Applied Sciences
Sankt Gallen, Canton of St. Gallen, 9001
About this study
The aim of the current study is the effect of SSOT during a 3-weeks inpatient pulmonary rehabilitation program. Further aim is to analyze exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at approx. 1600m "hypoxia", or breathing SSOT at 760m "hyperoxia" conditions during inpatient pulmonary rehabilitation.
The objective of the study is to provide long-awaited data concerning the use of SSOT during training. To date, it is not clear whether patients with chronic lung diseases who reveal a SpO2 > 88% at rest but desaturate during exercise and thus may not qualify for long-term oxygen therapy undergoing PR benefit from supplemental oxygen.
- Conditions
- COPD
- Being tested
- Oxygen, Standard ambiant air will be breathed during endurance training.
- Keywords
- Oxygen, Exercise, Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenOther
SSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training
Standard ambiant air will be breathed during endurance training.Other
ambiant air
| Study group | Role | What they receive |
|---|---|---|
| Normoxia | Sham comparator | Sham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula. Receives: Other: Standard ambiant air will be breathed during endurance training. |
| Hyperoxia | Active comparator | Standardized supplemental oxygen therapy (SSOT) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training Receives: Other: Oxygen |
| Hypoxia | Experimental | This group will train at moderate altitude. Receives: Other: Standard ambiant air will be breathed during endurance training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia
Measured: from baseline to 3 weeks
Secondary outcomes (6)
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 weeks at normoxia vs hypoxia vs hyperoxia
Measured: 3 weeks
Hospital Anxiety and Depression Scale (HADS) normoxia vs hypoxia vs hyperoxia
HADS-A (Anxiety): 7 items
HADS-D (Depression): 7 items
Each item is scored from 0 to 3, resulting in:
Minimum score per subscale: 0
Maximum score per subscale: 21
Interpretation:
Higher scores indicate worse psychological status.
Scores of 0-7: Normal
Scores of 8-10: Borderline abnormal
Scores of 11-21: Abnormal (clinically relevant anxiety or depression)
Measured: 3 weeks
mMRC score at normoxia vs hypoxia vs hyperoxia
The scale ranges from 0 to 4.
Each grade reflects a different level of functional limitation due to dyspnea.
Minimum score: 0 Maximum score: 4
Interpretation:
Higher scores indicate more severe dyspnea (worse outcome).
Measured: 3 weeks
CAT score (COPD assessments tool) normoxia vs hypoxia vs hyperoxia
It consists of 8 items, each scored from 0 to 5.
The total score ranges from:
Minimum score: 0 Maximum score: 40
Interpretation:
Higher scores indicate greater symptom burden and worse health status.
Score bands for interpretation:
0-10: Low impact
11-20: Medium impact
21-30: High impact
31-40: Very high impact
Measured: 3 weeks
Chronic respiratory questionnaire (CRQ) normoxia vs hypoxia vs hyperoxia
The CRQ consists of 20 items across four domains:
Dyspnea (5 items)
Fatigue (4 items)
Emotional function (7 items)
Mastery (4 items)
Each item is scored on a 7-point Likert scale:
Minimum score per item: 1
Maximum score per item: 7
Interpretation:
Higher scores indicate better health-related quality of life (less impairment).
Mean scores are calculated per domain and as a total score.
Measured: 3 weeks
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start23 Jul 2025
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Switzerland University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov, University of Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044843
- Sponsor's protocol ID
- inRehaExO2_normoxia_hyperoxia
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual patient data will be shared upon personal request to 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
- Oxygen Therapy During Exercise Training in Inpatient Rehabilitation in Chronic Lung Disease- Does it Matter?
- ClinicalTrials.gov ID
- NCT07044843
- Acronym / sponsor ID
- inRehaExO2_normoxia_hyperoxia
- Conditions
- COPD
- Keywords
- Oxygen, Exercise, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Eastern Switzerland University of Applied SciencesUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov, University of Zurich
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 1 Jul 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.
The aim of the current study is the effect of SSOT during a 3-weeks inpatient pulmonary rehabilitation program. Further aim is to analyze exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at approx. 1600m "hypoxia", or breathing SSOT at 760m "hyperoxia" conditions during inpatient pulmonary rehabilitation.
The objective of the study is to provide long-awaited data concerning the use of SSOT during training. To date, it is not clear whether patients with chronic lung diseases who reveal a SpO2 > 88% at rest but desaturate during exercise and thus may not qualify for long-term oxygen therapy undergoing PR benefit from supplemental oxygen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normoxia | Sham comparator | Other: Standard ambiant air will be breathed during endurance training.Sham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula. |
| Hyperoxia | Active comparator | Other: OxygenStandardized supplemental oxygen therapy (SSOT) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training |
| Hypoxia | Experimental | Other: Standard ambiant air will be breathed during endurance training.This group will train at moderate altitude. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged ≥ 18 years
- stable condition > 3 weeks (e.g. no exacerbations)
- resting SpO2 ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% and/or below 90% during a 6-minute walk test (6MWT)
- informed consent as documented by signature.
Key exclusion criteria (6 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
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 |
|---|---|---|
| OxygenSSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training | Other | Hyperoxia |
| Standard ambiant air will be breathed during endurance training.ambiant air | Other | Hypoxia, Normoxia |
Primary outcome
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia
Time frame: from baseline to 3 weeks
6 secondary outcomes
6 minute walk test (6MWT)
Time frame: 3 weeks
Hospital Anxiety and Depression Scale (HADS) normoxia vs hypoxia vs hyperoxia
Time frame: 3 weeks
mMRC score at normoxia vs hypoxia vs hyperoxia
Time frame: 3 weeks
CAT score (COPD assessments tool) normoxia vs hypoxia vs hyperoxia
Time frame: 3 weeks
Chronic respiratory questionnaire (CRQ) normoxia vs hypoxia vs hyperoxia
Time frame: 3 weeks
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia
Time frame: 3 months
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 10 Sep 2026.
- Individual participant dataSharing planned: No. individual patient data will be shared upon personal request to the corresponding author
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen and Standard ambiant air will be breathed during endurance training. in people with COPD, run by Eastern Switzerland University of Applied Sciences at 2 sites in 2 countries.
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 4 inclusion and 6 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 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 2 sites in Kyrgyzstan, 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?
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia (time frame: from baseline to 3 weeks). 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.