COPDNCT07063563
Effect of Rehabilitation at Moderate Altitude on Airway Resistance Measured With Forced Oscillation Technique in COPD-patients
A study testing ambiant air and Oxygen in people with COPD, run by Eastern Switzerland University of Applied Sciences at 2 sites in 2 countries.
Trial summary
Airway resistance will be measured using the forced oscillation technique (FOT). The parameters Rrs, Xrs, and ∆Xrs will be compared before and after a pulmonary rehabilitation cycle at moderate altitude. Additionally, the differences between low and moderate altitude will also be examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- ambiant air and Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Jul 2025to 31 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 clinical condition for >3 weeks (e.g., no exacerbations)
- Resting SpO₂ ≥88% and exercise-induced hypoxemia defined as a drop in SpO₂ of ≥4% and/or a level below 90% during the 6MWT
- Informed consent documented by signature
Who cannot join
- Severe daytime resting hypoxemia (SpO₂ <88%)
- Long-term oxygen therapy
- Unstable clinical condition requiring adjustment of pharmacological or other treatment modalities, need for intensive care, or presence of relevant severe comorbidities
- Inability to comply with study procedures (e.g., due to language barriers, psychological disorders, neurological or orthopedic impairments, walking disability, or inability to ride a bicycle)
- Women who are pregnant or breastfeeding
- Enrolment in another clinical trial involving 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, Kyrgyzstan
Switzerland1 site
Eastern Switzerland University of Applied Sciences
Sankt Gallen, Canton of St. Gallen, 9000
About this study
Official title: Effect of Rehabilitation at Moderate Altitude on Airway Resistance Measured With Forced Oscillation Technique in Patients With COPD
Airway resistance will be measured using the forced oscillation technique (FOT). The parameters Rrs, Xrs, and ∆Xrs will be compared before and after a pulmonary rehabilitation cycle at moderate altitude. Additionally, the differences between low and moderate altitude will also be examined.
- Conditions
- COPD
- Being tested
- ambiant air, Oxygen
- 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.
ambiant airOther
Standard ambiant air will be breathed during endurance training. ambiant air
OxygenOther
SSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training
ambiant airOther
Standard ambiant air will be breathed during endurance training. ambiant air
| Study group | Role | What they receive |
|---|---|---|
| Normoxia | Sham comparator | Sham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFlo TM via nasal cannula Receives: Other: ambiant air |
| Hyperoxia | Active comparator | Standardized supplemental oxygen therapy (SSOT) at 5 L/min will be delivered using the EverFlo™ oxygen concentrator via nasal cannula during training. Receives: Other: Oxygen |
| Hypoxia | Experimental | This group will train at moderate altitude Receives: Other: ambiant air |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change in Rrs (Respiratory System Resistance) before and after rehabilitation cycle
Rrs will be measured using the forced oscillation technique (FOT) in cmH₂O·s/L. Values will be assessed before and after the pulmonary rehabilitation cycle at moderate altitude
Measured: baseline to 3 weeks
Secondary outcomes (3)
Change in Xrs (Respiratory System Reactance) compared before and after the pulmonary rehabilitation.
Xrs will be measured using FOT in cmH₂O·s/L. Values will be compared before and after the pulmonary rehabilitation
Measured: baseline to 3 weeks
Change in ∆Xrs (Difference in Reactance) before and after rehabilitation
∆Xrs will be calculated as the difference between inspiratory and expiratory Xrs values, measured in cmH₂O·s/L, before and after rehabilitation.
Measured: baseline to 3 weeks
Change in Rrs, Xrs and ∆Xrs from low to moderate altitude
Measured: From baseline at low altitude to transfer to moderate altitude at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start23 Jul 2025
- Primary completion31 Dec 2025
- Study completion31 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
- 52 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
- NCT07063563
- Sponsor's protocol ID
- inRehaExO2_FOT
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2025
- Last updated
- 11 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rehabilitation at Moderate Altitude on Airway Resistance Measured With Forced Oscillation Technique in Patients With COPD
- ClinicalTrials.gov ID
- NCT07063563
- Acronym / sponsor ID
- inRehaExO2_FOT
- Conditions
- COPD
- Keywords
- Oxygen, Exercise, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 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
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 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.
Airway resistance will be measured using the forced oscillation technique (FOT). The parameters Rrs, Xrs, and ∆Xrs will be compared before and after a pulmonary rehabilitation cycle at moderate altitude. Additionally, the differences between low and moderate altitude will also be examined.
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: ambiant airSham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFlo TM via nasal cannula |
| Hyperoxia | Active comparator | Other: OxygenStandardized supplemental oxygen therapy (SSOT) at 5 L/min will be delivered using the EverFlo™ oxygen concentrator via nasal cannula during training. |
| Hypoxia | Experimental | Other: ambiant airThis 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 clinical condition for >3 weeks (e.g., no exacerbations)
- Resting SpO₂ ≥88% and exercise-induced hypoxemia defined as a drop in SpO₂ of ≥4% and/or a level below 90% during the 6MWT
- Informed consent documented by signature
Key exclusion criteria (6 listed)
- Severe daytime resting hypoxemia (SpO₂ <88%)
- Long-term oxygen therapy
- Unstable clinical condition requiring adjustment of pharmacological or other treatment modalities, need for intensive care, or presence of relevant severe comorbidities
- Inability to comply with study procedures (e.g., due to language barriers, psychological disorders, neurological or orthopedic impairments, walking disability, or inability to ride a bicycle)
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| ambiant airStandard ambiant air will be breathed during endurance training. ambiant air | Other | Hypoxia |
| OxygenSSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training | Other | Hyperoxia |
| ambiant airStandard ambiant air will be breathed during endurance training. ambiant air | Other | Normoxia |
Primary outcome
1. Change in Rrs (Respiratory System Resistance) before and after rehabilitation cycle
Time frame: baseline to 3 weeks
Rrs will be measured using the forced oscillation technique (FOT) in cmH₂O·s/L. Values will be assessed before and after the pulmonary rehabilitation cycle at moderate altitude
3 secondary outcomes
Change in Xrs (Respiratory System Reactance) compared before and after the pulmonary rehabilitation.
Time frame: baseline to 3 weeks
Change in ∆Xrs (Difference in Reactance) before and after rehabilitation
Time frame: baseline to 3 weeks
Change in Rrs, Xrs and ∆Xrs from low to moderate altitude
Time frame: From baseline at low altitude to transfer to moderate altitude at 3 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 11 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 ambiant air and Oxygen 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 11 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?
1. Change in Rrs (Respiratory System Resistance) before and after rehabilitation cycle (time frame: 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 11 Sep 2026.