Interstitial Lung DiseaseNCT04897048
Effect of Short-term Oxygen During CPET in ILD
A study testing Incremental exercise test (IET) and Constant work rate exercise test (CWRET) in people with Interstitial Lung Disease, run by University of Zurich at 1 site in Switzerland.
Trial summary
In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with interstitial lung disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Incremental exercise test (IET) and Constant work rate exercise test (CWRET)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2023to 1 Dec 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- interstitial lung disease, diagnosed by high-resolution CT
- FEV1/FVC >70% and FVC <85% predicted
- stable medication for at least 4 weeks
- Desaturation in SpO2 in 6-minute walk test of ≥ 4% to absolute values ≤ 92%
- Signed Informed Consent
- Male and female patients 18 to 80 years of age
Who cannot join
- Severe daytime hypoxemia (PaO2 ≤7.3 or <55 mmHg at rest)
- Other clinically significant concomitant disease states (e.g., cardiovascular disease, hepatic dysfunction, etc)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject, neurological or orthopaedic problems with walking disability or inability to ride a bicycle
- Women who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Respiratory Clinic, University Hospital of Zurich
Zurich, 8091
About this study
Official title: Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Interstitial Lung Disease (ILD)
In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with interstitial lung disease.
- Conditions
- Interstitial Lung Disease
- Being tested
- Incremental exercise test (IET), Constant work rate exercise test (CWRET)
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental exercise test (IET)Procedure or surgery
Incremental cardio pulmonary exercise test until exhaustion
Constant work rate exercise test (CWRET)Procedure or surgery
constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | Experimental | Supplemental oxygen will be applied via a mask during CPET Receives: Procedure: Incremental exercise test (IET); Procedure: Constant work rate exercise test (CWRET) |
| Air | Sham comparator | Sham ambient air will be applied via mask during CPET Receives: Procedure: Incremental exercise test (IET); Procedure: Constant work rate exercise test (CWRET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Rate (in watts)
Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests
Measured: 1 day
Endurance time (in seconds)
Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests
Measured: 1 day
Secondary outcomes (19)
changes in physiological vital signs: Heart rate (hr)
Hr (in beats per minute)
Measured: 1 day
changes in physiological vital signs: Blood pressure
Systolic and diastolic blood pressure (in mmHg)
Measured: 1 day
Changes in breathing patterns: Minute ventilation (VE)
VE (in liters per minute)
Measured: 1 day
Changes breathing patterns: Tidal volume (Vt)
Vt (in liters)
Measured: 1 day
Changes in breathing patterns: Oxygen uptake (VO2)
VO2 (in liters per minute)
Measured: 1 day
Changes in breathing patterns: Carbon dioxide output (VCO2)
VCO2 (in liters per minute)
Measured: 1 day
Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)
ratio between minute ventilation and oxygen uptake
Measured: 1 day
Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2)
ratio between minute ventilation and carbon dioxide output
Measured: 1 day
Changes in breathing patterns: VE/VCO2Slope
Ratio between minute ventilation and carbon dioxide output if carbon dioxide reaches the breathing plateau
Measured: 1 day
Changes in breathing patterns: Ventilatory threshold one (Vt1)
represents the start of anaerobic metabolism
Measured: 1 day
Changes in breathing patterns: Ventilatory threshold two (Vt2)
represents the start of higher percentage of the anaerobic metabolism
Measured: 1 day
Changes in arterial blood: arterial partial pressure of O2 (PaO2)
PaO2 (in kPa)
Measured: 1 day
Changes in arterial blood: arterial partial pressure of CO2 (PaCO2)
PaCO2 (in kPa)
Measured: 1 day
Changes in arterial blood: arterial lactate concentration
lactate concentration (in mmol per liter)
Measured: 1 day
Changes in arterial blood: pondus Hydrogenii (pH) values
pH (1-14)
Measured: 1 day
Changes in arterial blood: Bicarbonate (HCO3)
HCO3 (in mmol per liter)
Measured: 1 day
Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger)
SpO2 (in percent)
Measured: 1 day
Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead)
CTO (in percent)
Measured: 1 day
Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle)
MTO (in percent)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Jul 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897048
- Sponsor's protocol ID
- KEK-ZH-NR. 2012-0251_5
- Status last verified
- Nov 2022
- First submitted
- 9 May 2021
- Last updated
- 2 Nov 2022
- 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Interstitial Lung Disease (ILD)
- ClinicalTrials.gov ID
- NCT04897048
- Acronym / sponsor ID
- KEK-ZH-NR. 2012-0251_5
- Conditions
- Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 May 2021 (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.
In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with interstitial lung disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen | Experimental | Procedure: Incremental exercise test (IET), Procedure: Constant work rate exercise test (CWRET)Supplemental oxygen will be applied via a mask during CPET |
| Air | Sham comparator | Procedure: Incremental exercise test (IET), Procedure: Constant work rate exercise test (CWRET)Sham ambient air will be applied via mask during CPET |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- interstitial lung disease, diagnosed by high-resolution CT
- FEV1/FVC >70% and FVC <85% predicted
- stable medication for at least 4 weeks
- Desaturation in SpO2 in 6-minute walk test of ≥ 4% to absolute values ≤ 92%
- Signed Informed Consent
Key exclusion criteria (4 listed)
- Severe daytime hypoxemia (PaO2 ≤7.3 or <55 mmHg at rest)
- Other clinically significant concomitant disease states (e.g., cardiovascular disease, hepatic dysfunction, etc)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject, neurological or orthopaedic 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 |
|---|---|---|
| Incremental exercise test (IET)Incremental cardio pulmonary exercise test until exhaustion | Procedure or surgery | Air, Oxygen |
| Constant work rate exercise test (CWRET)constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion | Procedure or surgery | Air, Oxygen |
Primary outcome
Work Rate (in watts)
Time frame: 1 day
Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests
Endurance time (in seconds)
Time frame: 1 day
Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests
19 secondary outcomes
changes in physiological vital signs: Heart rate (hr)
Time frame: 1 day
changes in physiological vital signs: Blood pressure
Time frame: 1 day
Changes in breathing patterns: Minute ventilation (VE)
Time frame: 1 day
Changes breathing patterns: Tidal volume (Vt)
Time frame: 1 day
Changes in breathing patterns: Oxygen uptake (VO2)
Time frame: 1 day
Changes in breathing patterns: Carbon dioxide output (VCO2)
Time frame: 1 day
Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)
Time frame: 1 day
Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2)
Time frame: 1 day
Changes in breathing patterns: VE/VCO2Slope
Time frame: 1 day
Changes in breathing patterns: Ventilatory threshold one (Vt1)
Time frame: 1 day
Changes in breathing patterns: Ventilatory threshold two (Vt2)
Time frame: 1 day
Changes in arterial blood: arterial partial pressure of O2 (PaO2)
Time frame: 1 day
Changes in arterial blood: arterial partial pressure of CO2 (PaCO2)
Time frame: 1 day
Changes in arterial blood: arterial lactate concentration
Time frame: 1 day
Changes in arterial blood: pondus Hydrogenii (pH) values
Time frame: 1 day
Changes in arterial blood: Bicarbonate (HCO3)
Time frame: 1 day
Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger)
Time frame: 1 day
Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead)
Time frame: 1 day
Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incremental exercise test (IET) and Constant work rate exercise test (CWRET) in people with Interstitial Lung Disease, run by University of Zurich 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 6 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Ulrich, Prof. Dr. (+41442552220, silvia.ulrich@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Rate (in watts) (time frame: 1 day). The study lists 2 primary outcomes in all. 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 2 Nov 2022.