COPD (Chronic Obstructive Pulmonary Disease)NCT07107828
Effect of Rehabilitation on the Respiratory Signal in Patients With COPD and Exercise-Induced Desaturation
A study testing Ambient air, Oxygen and Altitude in people with COPD (Chronic Obstructive Pulmonary Disease), run by Eastern Switzerland University of Applied Sciences at 1 site in Kyrgyzstan.
Trial summary
The aim is to study the effect of SSOT during a 3-week in-patient pulmonary rehabilitation programme. Further aim is to analyse exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at 1600m "hypoxia", or breathing SSOT at 760m "hyperoxia" conditions, during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Ambient air, Oxygen and Altitude
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteKyrgyzstan
- 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 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
1 site in 1 country.
Kyrgyzstan1 site
National center for cardiology and internal medicine
Bishkek
About this study
Official title: Effect of Rehabilitation on the Respiratory Signal in Patients With Chronic Obstrucitve Pulmonary Disease (COPD) and Exercise-Induced Desaturation
The aim is to study the effect of SSOT during a 3-week in-patient pulmonary rehabilitation programme. Further aim is to analyse exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at 1600m "hypoxia", or breathing SSOT at 760m "hyperoxia" conditions, during in-patient pulmonary rehabilitation.
The objective of the main study is to provide long-awaited data concerning the use of SSOT during training. At present it is unclear whether patients with chronic lung diseases who reveal an SpO2 > 88% at rest, but desaturate during exercise, and, thus, may not qualify for long-term oxygen undergoing PR benefit from supplemental oxygen.
This sub-study will involve the subjects wearing the Respeck device and will focus on the effect of exercise on the respiratory signal measured by the Respeck.
- Being tested
- Ambient air, Oxygen, Altitude
- Keywords
- Rehabilitation, Exercise, Oxygen, Breathing
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambient airOther
Standard ambient air will be breathed during endurance training.
OxygenOther
SSOT will be applied during endurance training
AltitudeOther
Training will be performed at moderate altitude
| Study group | Role | What they receive |
|---|---|---|
| Normoxia | Sham comparator | Sham air (ambient air) will be applied with the oxygen concentrator EverFloTM via nasal cannula Receives: Other: Ambient air |
| Hyperoxia | Active comparator | Standardized supplemental oxygen (SSOT) will be applied with the oxygen concentrator EverFloTM via nasal cannula Receives: Other: Oxygen |
| Hypoxia | Experimental | This group will train at moderate altitude Receives: Other: Altitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of respiratory rate (in terms of breaths/minute)
The longitudinal analysis of features extracted from the continuous Respeck respiratory flow/effort signals pre and post the 3-week in-house rehabilitation programme, and comparisons between the different groups.
Measured: 3 weeks
Secondary outcomes (3)
Comparison of respiratory rate (in terms of breaths/minute)
Analysis of the respiratory signal before and after 6-minute walking distance
Measured: before and after 6-minute walking distance
Comparison of respiratory rate (in terms of breaths/minute)
Analysis of the respiratory signal before and after constant work rate exercise test
Measured: before and after constant work rate exercise test
Comparison of respiratory rate (in terms of breaths/minute)
Analysis of the respiratory signal before and after exercise (6-minute walking distance and constant work rate exercise test), and comparing before and after rehabilitation.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 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 COPD (Chronic Obstructive Pulmonary Disease)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
- 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
- University of Edinburgh, National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107828
- Sponsor's protocol ID
- inRehaExO2_Respeck
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only 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 on the Respiratory Signal in Patients With Chronic Obstrucitve Pulmonary Disease (COPD) and Exercise-Induced Desaturation
- ClinicalTrials.gov ID
- NCT07107828
- Acronym / sponsor ID
- inRehaExO2_Respeck
- Keywords
- Rehabilitation, Exercise, Oxygen, Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eastern Switzerland University of Applied SciencesUniversity, hospital or other
- Collaborators
- University of Edinburgh, National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Aug 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 is to study the effect of SSOT during a 3-week in-patient pulmonary rehabilitation programme. Further aim is to analyse exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at 1600m "hypoxia", or breathing SSOT at 760m "hyperoxia" conditions, during in-patient pulmonary rehabilitation.
The objective of the main study is to provide long-awaited data concerning the use of SSOT during training. At present it is unclear whether patients with chronic lung diseases who reveal an SpO2 > 88% at rest, but desaturate during exercise, and, thus, may not qualify for long-term oxygen undergoing PR benefit from supplemental oxygen.
This sub-study will involve the subjects wearing the Respeck device and will focus on the effect of exercise on the respiratory signal measured by the Respeck.
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: Ambient airSham air (ambient air) will be applied with the oxygen concentrator EverFloTM via nasal cannula |
| Hyperoxia | Active comparator | Other: OxygenStandardized supplemental oxygen (SSOT) will be applied with the oxygen concentrator EverFloTM via nasal cannula |
| Hypoxia | Experimental | Other: AltitudeThis 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 |
|---|---|---|
| Ambient airStandard ambient air will be breathed during endurance training. | Other | Normoxia |
| OxygenSSOT will be applied during endurance training | Other | Hyperoxia |
| AltitudeTraining will be performed at moderate altitude | Other | Hypoxia |
Primary outcome
Comparison of respiratory rate (in terms of breaths/minute)
Time frame: 3 weeks
The longitudinal analysis of features extracted from the continuous Respeck respiratory flow/effort signals pre and post the 3-week in-house rehabilitation programme, and comparisons between the different groups.
3 secondary outcomes
Comparison of respiratory rate (in terms of breaths/minute)
Time frame: before and after 6-minute walking distance
Comparison of respiratory rate (in terms of breaths/minute)
Time frame: before and after constant work rate exercise test
Comparison of respiratory rate (in terms of breaths/minute)
Time frame: 3 weeks
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. IPD will only be shared upon personal request to the corresponding author.
Related trials for COPD (Chronic Obstructive Pulmonary Disease)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambient air, Oxygen and Altitude in people with COPD (Chronic Obstructive Pulmonary Disease), run by Eastern Switzerland University of Applied Sciences at 1 site in Kyrgyzstan.
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 1 site in Kyrgyzstan. 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?
Comparison of respiratory rate (in terms of breaths/minute) (time frame: 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.