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Pulmonary Diffusing Capacity During Acute Exercise in Patients With COPD

Pulmonary Diffusing Capacity to Nitric Oxide and Carbon Monoxide During Exercise in Patients With Chronic Obstructive Pulmonary Disease: a Test-retest Reliability Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05583396
Acronym
DiffLung2
Enrollment
15
Registered
2022-10-17
Start date
2022-11-01
Completion date
2023-08-01
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary diffusing capacity, Reliability, Test-retest

Brief 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). 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.

Interventions

DIAGNOSTIC_TESTAcute exercise

The measurement will be repeated within one to seven days.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Chronic obstructive pulmonary disease (GOLD II + III)

Exclusion criteria

* Known heart disease * Pregnancy * Disease within two weeks prior to inclusion

Design outcomes

Primary

MeasureTime frameDescription
ICC for VA during exerciseMeasured at day 1 and day 2ICC for VA with 95% CI during exercise
SRD for DM during exerciseMeasured at day 1 and day 2SRD with 95% CI for DM during exercise
SRD for Pulmonary blood volume (Vc) at restMeasured at day 1 and day 2SRD with 95% CI for Vc at rest
SRD for Vc during exerciseMeasured at day 1 and day 2SRD with 95% CI for Vc during exercise
SRD for alveolar volume (VA) at restMeasured at day 1 and day 2SRD with 95 % CI for VA at rest
SRD for VA during exerciseMeasured at day 1 and day 2SRD with 95 % CI for VA during exercise
Coefficient of Variance (CV) for DLNO at restMeasured at day 1 and day 2CV with a 95% CI at rest
CV for DLNO during exerciseMeasured at day 1 and day 2CV with a 95% CI during exercise
CV for DLCOc at restMeasured at day 1 and day 2CV with 95% CI for DLCOc at rest
CV for DLCOc during exerciseMeasured at day 1 and day 2CV with 95% CI for DLCOc during exercise
CV for DM at restMeasured at day 1 and day 2CV with 95% CI for DM at rest
CV for DM during exerciseMeasured at day 1 and day 2CV with 95% CI for DM during exercise
CV for Vc at restMeasured at day 1 and day 2CV with 95% CI for DM at rest
CV for Vc during exerciseMeasured at day 1 and day 2CV with 95% CI for DM during exercise
CV for VA at restMeasured at day 1 and day 2CV with 95% CI for VA at rest
CV for VA during exerciseMeasured at day 1 and day 2CV with 95% CI for VA during exercise
Intraclass correlation coefficient (ICC) for DLNO at restMeasured at day 1 and day 2ICC for DLNO with 95% CI at rest
Intraclass correlation coefficient (ICC) for DLNO during exerciseMeasured at day 1 and day 2ICC for DLNO with 95% CI during exercise
ICC for DLCOc at restMeasured at day 1 and day 2ICC for DLCOc with 95% CI at rest
ICC for DLCOc during exerciseMeasured at day 1 and day 2ICC for DLCOc with 95% CI during exercise
ICC for DM at restMeasured at day 1 and day 2ICC for DM with 95% CI at rest
ICC for DM during exerciseMeasured at day 1 and day 2ICC for DM with 95% CI during exercise
ICC for VC at restMeasured at day 1 and day 2ICC for VC with 95% CI at rest
ICC for VC during exerciseMeasured at day 1 and day 2ICC for VC with 95% CI during exercise
ICC for VA at restMeasured at day 1 and day 2ICC for VA with 95% CI at rest
Rest-to-exercise change in DLNOMeasured at day 1 and day 2The 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 DLCOcMeasured at day 1 and day 2The 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 DMMeasured at day 1 and day 2The 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 VCMeasured at day 1 and day 2The 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 VAMeasured at day 1 and day 2The 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 restMeasured at day 1 and day 2SRD with 95 % confidence intervals (95% CI) for DLNO at rest
SRD for DLNO during exerciseMeasured at day 1 and day 2SRD with 95% CI for DLNO during exercise
SRD for Diffusion capacity for carbon monoxide (DLCOc) at restMeasured at day 1 and day 2SRD with 95% CI for DLCOc at rest
SRD for DLCOc during exerciseMeasured at day 1 and day 2SRD with 95% CI for DLCOc during exercise
SRD for membrane diffusing capacity (DM) at restMeasured at day 1 and day 2SRD with 95% CI for DM at rest

Secondary

MeasureTime frameDescription
Alveolar volume (VA) during exerciseMeasured at day 1 and day 2VA during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Bland Altman Plot - DLNOMeasured at day 1 and day 2Bland Altman plot for repeated measures for DLNO
Bland Altman Plot - DLCOcMeasured at day 1 and day 2Bland Altman plot for repeated measures for DLCOc
Bland Altman Plot - DMMeasured at day 1 and day 2Bland Altman plot for repeated measures for DM
Bland Altman Plot - VCMeasured at day 1 and day 2Bland Altman plot for repeated measures for VC
Bland Altman Plot - VAMeasured at day 1 and day 2Bland Altman plot for repeated measures for VA
Breath hold time at restMeasured at day 1 and day 2Breath hold time at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Diffusion capacity for nitric oxide (DLNO) at restMeasured at day 1 and day 2DLNO at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Diffusion capacity for nitric oxide (DLNO) during exerciseMeasured at day 1 and day 2DLNO during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Pulmonary blood volume (Vc) during exerciseMeasured at day 1 and day 2VC during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Diffusion capacity for carbon monoxide (DLCOc) at restMeasured at day 1 and day 2DLCOc at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Diffusion capacity for carbon monoxide (DLCOc) during exerciseMeasured at day 1 and day 2DLCOc during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Membrane diffusing capacity (DM) at restMeasured at day 1 and day 2DM at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Membrane diffusing capacity (DM) during exerciseMeasured at day 1 and day 2DM during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Pulmonary blood volume (Vc) at restMeasured at day 1 and day 2VC at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Breath hold time during exerciseMeasured at day 1 and day 2Breath hold time during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Alveolar volume (VA) at restMeasured at day 1 and day 2VA at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.

Other

MeasureTime frameDescription
Diffusion capacity for carbon monoxide corrected for hemoglobinMeasured at baselineDLCOc measured and expressed as mmol/(min\*kPa) and percentage of predicted.
Forced Expiratory Volume in 1 second (FEV1)Measured at baselineFEV1 measured during dynamic spirometry, and expressed as liter and percentage of predicted.
Forced vital capacity (FVC)Measured at baselineFVC measured during dynamic spirometry, and expressed as liter and percentage of predicted.
FEV1/FVC ratioMeasured at baselineFEV1/FVC measured during dynamic spirometry, and expressed as liter and percentage of predicted.
Residual Volume (RV)Measured at baselineRV measured with whole-body plethysmography, and expressed as liter and percentage of predicted.
Total Lung Capacity (TLC)Measured at baselineTLC measured with whole-body plethysmography, and expressed as liter and percentage of predicted.
Peak oxygen consumption (VO2peak)Measured at baselineVO2peak test performed on a Monark ergometer bicycle.

Countries

Denmark

Contacts

Primary ContactRonan Berg, MD
ronan.martin.griffin.berg@regionh.dk+45-35451825

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026