Chronic Obstructive Pulmonary DiseaseDiffLung2NCT05583396
Pulmonary Diffusing Capacity During Acute Exercise in Patients With COPD
A study testing Acute exercise in people with Chronic Obstructive Pulmonary Disease, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) during exercise may be a useful physiological measure of alveolar-capillary reserve in patients with Chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Acute exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Nov 2022to 1 Aug 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic obstructive pulmonary disease (GOLD II + III)
Who cannot join
- Known heart disease
- Pregnancy
- Disease within two weeks prior to inclusion
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Centre for Physical Activity Research (CFAS)
Copenhagen, 2100
Jacob Peter Hartmann, MD, 40924285, jacob.peter.okholm.hartmann.01@regionh.dk
- Recruiting
Rigshospitalet
Copenhagen, 2100
Ronan Berg, MD, +45-35451825, ronan@sund.ku.dk
Regitse Christensen, MD, +45-35451825, Regitse.Hoejgaard.Christensen@regionh.dk
About this study
Official title: Pulmonary Diffusing Capacity to Nitric Oxide and Carbon Monoxide During Exercise in Patients With Chronic Obstructive Pulmonary Disease: a Test-retest Reliability Study
The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) during exercise may be a useful physiological measure of alveolar-capillary reserve in patients with Chronic obstructive pulmonary disease (COPD). The present study investigated the test-retest reliability of DLCO/NO-based metrics.
Read the detailed description
The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) has recently been standardised and validated for clinical use. It is thus ideal for assessing acute changes in pulmonary diffusing capacity and its components during various physiological manoeuvres. These changes are thought to involve acute changes in pulmonary perfusion and are notably relevant for patients with chronic obstructive pulmonary disease (COPD), in which they may be related to exertional dyspnoea. The aim of the present study is to investigate the effects of acute exercise on pulmonary diffusing capacity, and to determine the day-to-day repeatability of such assessments.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Acute exercise
- Keywords
- Pulmonary diffusing capacity, Reliability, Test-retest
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute exerciseDiagnostic test
The measurement will be repeated within one to seven days.
| Study group | Role | What they receive |
|---|---|---|
| Acute exercise | Other | Pulmonary diffusing capacity using the DLCO/NO technique is assessed at rest and during exercise (60% of maximal workload on a bicycle ergometer) Receives: Diagnostic Test: Acute exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rest-to-exercise change in DLNO
The physiological change from rest to exercise in DLNO obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Rest-to-exercise change in DLCOc
The physiological change from rest to exercise in DLCOc obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Rest-to-exercise change in DM
The physiological change from rest to exercise in DM obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Rest-to-exercise change in VC
The physiological change from rest to exercise in VC obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Rest-to-exercise change in VA
The physiological change from rest to exercise in VA obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Smallest real difference (SRD) for Diffusion capacity for DLNO at rest
SRD with 95 % confidence intervals (95% CI) for DLNO at rest
Measured: Measured at day 1 and day 2
SRD for DLNO during exercise
SRD with 95% CI for DLNO during exercise
Measured: Measured at day 1 and day 2
SRD for Diffusion capacity for carbon monoxide (DLCOc) at rest
SRD with 95% CI for DLCOc at rest
Measured: Measured at day 1 and day 2
SRD for DLCOc during exercise
SRD with 95% CI for DLCOc during exercise
Measured: Measured at day 1 and day 2
SRD for membrane diffusing capacity (DM) at rest
SRD with 95% CI for DM at rest
Measured: Measured at day 1 and day 2
SRD for DM during exercise
SRD with 95% CI for DM during exercise
Measured: Measured at day 1 and day 2
SRD for Pulmonary blood volume (Vc) at rest
SRD with 95% CI for Vc at rest
Measured: Measured at day 1 and day 2
SRD for Vc during exercise
SRD with 95% CI for Vc during exercise
Measured: Measured at day 1 and day 2
SRD for alveolar volume (VA) at rest
SRD with 95 % CI for VA at rest
Measured: Measured at day 1 and day 2
SRD for VA during exercise
SRD with 95 % CI for VA during exercise
Measured: Measured at day 1 and day 2
Coefficient of Variance (CV) for DLNO at rest
CV with a 95% CI at rest
Measured: Measured at day 1 and day 2
CV for DLNO during exercise
CV with a 95% CI during exercise
Measured: Measured at day 1 and day 2
CV for DLCOc at rest
CV with 95% CI for DLCOc at rest
Measured: Measured at day 1 and day 2
CV for DLCOc during exercise
CV with 95% CI for DLCOc during exercise
Measured: Measured at day 1 and day 2
CV for DM at rest
CV with 95% CI for DM at rest
Measured: Measured at day 1 and day 2
CV for DM during exercise
CV with 95% CI for DM during exercise
Measured: Measured at day 1 and day 2
CV for Vc at rest
CV with 95% CI for DM at rest
Measured: Measured at day 1 and day 2
CV for Vc during exercise
CV with 95% CI for DM during exercise
Measured: Measured at day 1 and day 2
CV for VA at rest
CV with 95% CI for VA at rest
Measured: Measured at day 1 and day 2
CV for VA during exercise
CV with 95% CI for VA during exercise
Measured: Measured at day 1 and day 2
Intraclass correlation coefficient (ICC) for DLNO at rest
ICC for DLNO with 95% CI at rest
Measured: Measured at day 1 and day 2
Intraclass correlation coefficient (ICC) for DLNO during exercise
ICC for DLNO with 95% CI during exercise
Measured: Measured at day 1 and day 2
ICC for DLCOc at rest
ICC for DLCOc with 95% CI at rest
Measured: Measured at day 1 and day 2
ICC for DLCOc during exercise
ICC for DLCOc with 95% CI during exercise
Measured: Measured at day 1 and day 2
ICC for DM at rest
ICC for DM with 95% CI at rest
Measured: Measured at day 1 and day 2
ICC for DM during exercise
ICC for DM with 95% CI during exercise
Measured: Measured at day 1 and day 2
ICC for VC at rest
ICC for VC with 95% CI at rest
Measured: Measured at day 1 and day 2
ICC for VC during exercise
ICC for VC with 95% CI during exercise
Measured: Measured at day 1 and day 2
ICC for VA at rest
ICC for VA with 95% CI at rest
Measured: Measured at day 1 and day 2
ICC for VA during exercise
ICC for VA with 95% CI during exercise
Measured: Measured at day 1 and day 2
Secondary outcomes (17)
Diffusion capacity for nitric oxide (DLNO) at rest
DLNO at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Diffusion capacity for nitric oxide (DLNO) during exercise
DLNO during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Diffusion capacity for carbon monoxide (DLCOc) at rest
DLCOc at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Diffusion capacity for carbon monoxide (DLCOc) during exercise
DLCOc during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Membrane diffusing capacity (DM) at rest
DM at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Membrane diffusing capacity (DM) during exercise
DM during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Pulmonary blood volume (Vc) at rest
VC at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Pulmonary blood volume (Vc) during exercise
VC during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Breath hold time at rest
Breath hold time at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Breath hold time during exercise
Breath hold time during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Alveolar volume (VA) at rest
VA at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Alveolar volume (VA) during exercise
VA during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Measured: Measured at day 1 and day 2
Bland Altman Plot - DLNO
Bland Altman plot for repeated measures for DLNO
Measured: Measured at day 1 and day 2
Bland Altman Plot - DLCOc
Bland Altman plot for repeated measures for DLCOc
Measured: Measured at day 1 and day 2
Bland Altman Plot - DM
Bland Altman plot for repeated measures for DM
Measured: Measured at day 1 and day 2
Bland Altman Plot - VC
Bland Altman plot for repeated measures for VC
Measured: Measured at day 1 and day 2
Bland Altman Plot - VA
Bland Altman plot for repeated measures for VA
Measured: Measured at day 1 and day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Nov 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 Aug 2023 (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 DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronan Berg, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583396
- Sponsor's protocol ID
- DiffLung2
- Acronym
- DiffLung2
- Status last verified
- Nov 2022
- First submitted
- 13 Oct 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be openly available in a repository.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Diffusing Capacity to Nitric Oxide and Carbon Monoxide During Exercise in Patients With Chronic Obstructive Pulmonary Disease: a Test-retest Reliability Study
- ClinicalTrials.gov ID
- NCT05583396
- Acronym / sponsor ID
- DiffLung2 / DiffLung2
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary diffusing capacity, Reliability, Test-retest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 17 Oct 2022 (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 combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) during exercise may be a useful physiological measure of alveolar-capillary reserve in patients with Chronic obstructive pulmonary disease (COPD). The present study investigated the test-retest reliability of DLCO/NO-based metrics.
Detailed description
The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) has recently been standardised and validated for clinical use. It is thus ideal for assessing acute changes in pulmonary diffusing capacity and its components during various physiological manoeuvres. These changes are thought to involve acute changes in pulmonary perfusion and are notably relevant for patients with chronic obstructive pulmonary disease (COPD), in which they may be related to exertional dyspnoea. The aim of the present study is to investigate the effects of acute exercise on pulmonary diffusing capacity, and to determine the day-to-day repeatability of such assessments.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute exercise | Other | Diagnostic Test: Acute exercisePulmonary diffusing capacity using the DLCO/NO technique is assessed at rest and during exercise (60% of maximal workload on a bicycle ergometer) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic obstructive pulmonary disease (GOLD II + III)
Key exclusion criteria (3 listed)
- Known heart disease
- Pregnancy
- Disease within two weeks prior to inclusion
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 |
|---|---|---|
| Acute exerciseThe measurement will be repeated within one to seven days. | Diagnostic test | Acute exercise |
Primary outcome
Rest-to-exercise change in DLNO
Time frame: Measured at day 1 and day 2
The physiological change from rest to exercise in DLNO obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Rest-to-exercise change in DLCOc
Time frame: Measured at day 1 and day 2
The physiological change from rest to exercise in DLCOc obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Rest-to-exercise change in DM
Time frame: Measured at day 1 and day 2
The physiological change from rest to exercise in DM obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Rest-to-exercise change in VC
Time frame: Measured at day 1 and day 2
The physiological change from rest to exercise in VC obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Rest-to-exercise change in VA
Time frame: Measured at day 1 and day 2
The physiological change from rest to exercise in VA obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Smallest real difference (SRD) for Diffusion capacity for DLNO at rest
Time frame: Measured at day 1 and day 2
SRD with 95 % confidence intervals (95% CI) for DLNO at rest
SRD for DLNO during exercise
Time frame: Measured at day 1 and day 2
SRD with 95% CI for DLNO during exercise
SRD for Diffusion capacity for carbon monoxide (DLCOc) at rest
Time frame: Measured at day 1 and day 2
SRD with 95% CI for DLCOc at rest
SRD for DLCOc during exercise
Time frame: Measured at day 1 and day 2
SRD with 95% CI for DLCOc during exercise
SRD for membrane diffusing capacity (DM) at rest
Time frame: Measured at day 1 and day 2
SRD with 95% CI for DM at rest
SRD for DM during exercise
Time frame: Measured at day 1 and day 2
SRD with 95% CI for DM during exercise
SRD for Pulmonary blood volume (Vc) at rest
Time frame: Measured at day 1 and day 2
SRD with 95% CI for Vc at rest
SRD for Vc during exercise
Time frame: Measured at day 1 and day 2
SRD with 95% CI for Vc during exercise
SRD for alveolar volume (VA) at rest
Time frame: Measured at day 1 and day 2
SRD with 95 % CI for VA at rest
SRD for VA during exercise
Time frame: Measured at day 1 and day 2
SRD with 95 % CI for VA during exercise
Coefficient of Variance (CV) for DLNO at rest
Time frame: Measured at day 1 and day 2
CV with a 95% CI at rest
CV for DLNO during exercise
Time frame: Measured at day 1 and day 2
CV with a 95% CI during exercise
CV for DLCOc at rest
Time frame: Measured at day 1 and day 2
CV with 95% CI for DLCOc at rest
CV for DLCOc during exercise
Time frame: Measured at day 1 and day 2
CV with 95% CI for DLCOc during exercise
CV for DM at rest
Time frame: Measured at day 1 and day 2
CV with 95% CI for DM at rest
CV for DM during exercise
Time frame: Measured at day 1 and day 2
CV with 95% CI for DM during exercise
CV for Vc at rest
Time frame: Measured at day 1 and day 2
CV with 95% CI for DM at rest
CV for Vc during exercise
Time frame: Measured at day 1 and day 2
CV with 95% CI for DM during exercise
CV for VA at rest
Time frame: Measured at day 1 and day 2
CV with 95% CI for VA at rest
CV for VA during exercise
Time frame: Measured at day 1 and day 2
CV with 95% CI for VA during exercise
Intraclass correlation coefficient (ICC) for DLNO at rest
Time frame: Measured at day 1 and day 2
ICC for DLNO with 95% CI at rest
Intraclass correlation coefficient (ICC) for DLNO during exercise
Time frame: Measured at day 1 and day 2
ICC for DLNO with 95% CI during exercise
ICC for DLCOc at rest
Time frame: Measured at day 1 and day 2
ICC for DLCOc with 95% CI at rest
ICC for DLCOc during exercise
Time frame: Measured at day 1 and day 2
ICC for DLCOc with 95% CI during exercise
ICC for DM at rest
Time frame: Measured at day 1 and day 2
ICC for DM with 95% CI at rest
ICC for DM during exercise
Time frame: Measured at day 1 and day 2
ICC for DM with 95% CI during exercise
ICC for VC at rest
Time frame: Measured at day 1 and day 2
ICC for VC with 95% CI at rest
ICC for VC during exercise
Time frame: Measured at day 1 and day 2
ICC for VC with 95% CI during exercise
ICC for VA at rest
Time frame: Measured at day 1 and day 2
ICC for VA with 95% CI at rest
ICC for VA during exercise
Time frame: Measured at day 1 and day 2
ICC for VA with 95% CI during exercise
17 secondary outcomes
Diffusion capacity for nitric oxide (DLNO) at rest
Time frame: Measured at day 1 and day 2
Diffusion capacity for nitric oxide (DLNO) during exercise
Time frame: Measured at day 1 and day 2
Diffusion capacity for carbon monoxide (DLCOc) at rest
Time frame: Measured at day 1 and day 2
Diffusion capacity for carbon monoxide (DLCOc) during exercise
Time frame: Measured at day 1 and day 2
Membrane diffusing capacity (DM) at rest
Time frame: Measured at day 1 and day 2
Membrane diffusing capacity (DM) during exercise
Time frame: Measured at day 1 and day 2
Pulmonary blood volume (Vc) at rest
Time frame: Measured at day 1 and day 2
Pulmonary blood volume (Vc) during exercise
Time frame: Measured at day 1 and day 2
Breath hold time at rest
Time frame: Measured at day 1 and day 2
Breath hold time during exercise
Time frame: Measured at day 1 and day 2
Alveolar volume (VA) at rest
Time frame: Measured at day 1 and day 2
Alveolar volume (VA) during exercise
Time frame: Measured at day 1 and day 2
Bland Altman Plot - DLNO
Time frame: Measured at day 1 and day 2
Bland Altman Plot - DLCOc
Time frame: Measured at day 1 and day 2
Bland Altman Plot - DM
Time frame: Measured at day 1 and day 2
Bland Altman Plot - VC
Time frame: Measured at day 1 and day 2
Bland Altman Plot - VA
Time frame: Measured at day 1 and day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: Yes. The data will be openly available in a repository.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute exercise in people with Chronic Obstructive Pulmonary Disease, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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 1 inclusion and 3 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 21 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 2 sites in Denmark. 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. 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 Ronan Berg, MD (+45-35451825, ronan.martin.griffin.berg@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rest-to-exercise change in DLNO (time frame: Measured at day 1 and day 2). The study lists 35 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 21 Nov 2022.