Clinical trial NCT05583396: Pulmonary Diffusing Capacity During Acute Exercise in Patients With COPD
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary diffusing capacity
Reliability
Test-retest
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Chronic obstructive pulmonary disease (GOLD II + III)

Exclusion Criteria:

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

Primary outcomes:
measure: Rest-to-exercise change in DLNO
timeFrame: Measured at day 1 and day 2
measure: Rest-to-exercise change in DLCOc
timeFrame: Measured at day 1 and day 2
measure: Rest-to-exercise change in DM
timeFrame: Measured at day 1 and day 2
measure: Rest-to-exercise change in VC
timeFrame: Measured at day 1 and day 2
measure: Rest-to-exercise change in VA
timeFrame: Measured at day 1 and day 2
measure: Smallest real difference (SRD) for Diffusion capacity for DLNO at rest
timeFrame: Measured at day 1 and day 2
measure: SRD for DLNO during exercise
timeFrame: Measured at day 1 and day 2
measure: SRD for Diffusion capacity for carbon monoxide (DLCOc) at rest
timeFrame: Measured at day 1 and day 2
measure: SRD for DLCOc during exercise
timeFrame: Measured at day 1 and day 2
measure: SRD for membrane diffusing capacity (DM) at rest
timeFrame: Measured at day 1 and day 2
measure: SRD for DM during exercise
timeFrame: Measured at day 1 and day 2
measure: SRD for Pulmonary blood volume (Vc) at rest
timeFrame: Measured at day 1 and day 2
measure: SRD for Vc during exercise
timeFrame: Measured at day 1 and day 2
measure: SRD for alveolar volume (VA) at rest
timeFrame: Measured at day 1 and day 2
measure: SRD for VA during exercise
timeFrame: Measured at day 1 and day 2
measure: Coefficient of Variance (CV) for DLNO at rest
timeFrame: Measured at day 1 and day 2
measure: CV for DLNO during exercise
timeFrame: Measured at day 1 and day 2
measure: CV for DLCOc at rest
timeFrame: Measured at day 1 and day 2
measure: CV for DLCOc during exercise
timeFrame: Measured at day 1 and day 2
measure: CV for DM at rest
timeFrame: Measured at day 1 and day 2
measure: CV for DM during exercise
timeFrame: Measured at day 1 and day 2
measure: CV for Vc at rest
timeFrame: Measured at day 1 and day 2
measure: CV for Vc during exercise
timeFrame: Measured at day 1 and day 2
measure: CV for VA at rest
timeFrame: Measured at day 1 and day 2
measure: CV for VA during exercise
timeFrame: Measured at day 1 and day 2
measure: Intraclass correlation coefficient (ICC) for DLNO at rest
timeFrame: Measured at day 1 and day 2
measure: Intraclass correlation coefficient (ICC) for DLNO during exercise
timeFrame: Measured at day 1 and day 2
measure: ICC for DLCOc at rest
timeFrame: Measured at day 1 and day 2
measure: ICC for DLCOc during exercise
timeFrame: Measured at day 1 and day 2
measure: ICC for DM at rest
timeFrame: Measured at day 1 and day 2
measure: ICC for DM during exercise
timeFrame: Measured at day 1 and day 2
measure: ICC for VC at rest
timeFrame: Measured at day 1 and day 2
measure: ICC for VC during exercise
timeFrame: Measured at day 1 and day 2
measure: ICC for VA at rest
timeFrame: Measured at day 1 and day 2
measure: ICC for VA during exercise
timeFrame: Measured at day 1 and day 2
Secondary outcomes:
measure: Diffusion capacity for nitric oxide (DLNO) at rest
timeFrame: Measured at day 1 and day 2
measure: Diffusion capacity for nitric oxide (DLNO) during exercise
timeFrame: Measured at day 1 and day 2
measure: Diffusion capacity for carbon monoxide (DLCOc) at rest
timeFrame: Measured at day 1 and day 2
measure: Diffusion capacity for carbon monoxide (DLCOc) during exercise
timeFrame: Measured at day 1 and day 2
measure: Membrane diffusing capacity (DM) at rest
timeFrame: Measured at day 1 and day 2
measure: Membrane diffusing capacity (DM) during exercise
timeFrame: Measured at day 1 and day 2
measure: Pulmonary blood volume (Vc) at rest
timeFrame: Measured at day 1 and day 2
measure: Pulmonary blood volume (Vc) during exercise
timeFrame: Measured at day 1 and day 2
measure: Breath hold time at rest
timeFrame: Measured at day 1 and day 2
measure: Breath hold time during exercise
timeFrame: Measured at day 1 and day 2
measure: Alveolar volume (VA) at rest
timeFrame: Measured at day 1 and day 2
measure: Alveolar volume (VA) during exercise
timeFrame: Measured at day 1 and day 2
measure: Bland Altman Plot - DLNO
timeFrame: Measured at day 1 and day 2
measure: Bland Altman Plot - DLCOc
timeFrame: Measured at day 1 and day 2
measure: Bland Altman Plot - DM
timeFrame: Measured at day 1 and day 2
measure: Bland Altman Plot - VC
timeFrame: Measured at day 1 and day 2
measure: Bland Altman Plot - VA
timeFrame: Measured at day 1 and day 2
Other outcomes:
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: Measured at baseline
measure: Forced vital capacity (FVC)
timeFrame: Measured at baseline
measure: FEV1/FVC ratio
timeFrame: Measured at baseline
measure: Residual Volume (RV)
timeFrame: Measured at baseline
measure: Total Lung Capacity (TLC)
timeFrame: Measured at baseline
measure: Diffusion capacity for carbon monoxide corrected for hemoglobin
timeFrame: Measured at baseline
measure: Peak oxygen consumption (VO2peak)
timeFrame: Measured at baseline
Locations:
city: Copenhagen
country: Denmark
facility: Centre for Physical Activity Research (CFAS)
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References: