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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05583396
Other study ID # DiffLung2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date August 1, 2023

Study information

Verified date November 2022
Source Rigshospitalet, Denmark
Contact Ronan Berg, MD
Phone +45-35451825
Email ronan.martin.griffin.berg@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). The present study investigated the test-retest reliability of DLCO/NO-based metrics.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date August 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Chronic obstructive pulmonary disease (GOLD II + III) Exclusion Criteria: - Known heart disease - Pregnancy - Disease within two weeks prior to inclusion

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Acute exercise
The measurement will be repeated within one to seven days.

Locations

Country Name City State
Denmark Centre for Physical Activity Research (CFAS) Copenhagen
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Forced Expiratory Volume in 1 second (FEV1) FEV1 measured during dynamic spirometry, and expressed as liter and percentage of predicted. Measured at baseline
Other Forced vital capacity (FVC) FVC measured during dynamic spirometry, and expressed as liter and percentage of predicted. Measured at baseline
Other FEV1/FVC ratio FEV1/FVC measured during dynamic spirometry, and expressed as liter and percentage of predicted. Measured at baseline
Other Residual Volume (RV) RV measured with whole-body plethysmography, and expressed as liter and percentage of predicted. Measured at baseline
Other Total Lung Capacity (TLC) TLC measured with whole-body plethysmography, and expressed as liter and percentage of predicted. Measured at baseline
Other Diffusion capacity for carbon monoxide corrected for hemoglobin DLCOc measured and expressed as mmol/(min*kPa) and percentage of predicted. Measured at baseline
Other Peak oxygen consumption (VO2peak) VO2peak test performed on a Monark ergometer bicycle. Measured at baseline
Primary 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 at day 1 and day 2
Primary 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 at day 1 and day 2
Primary 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 at day 1 and day 2
Primary 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 at day 1 and day 2
Primary 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 at day 1 and day 2
Primary Smallest real difference (SRD) for Diffusion capacity for DLNO at rest SRD with 95 % confidence intervals (95% CI) for DLNO at rest Measured at day 1 and day 2
Primary SRD for DLNO during exercise SRD with 95% CI for DLNO during exercise Measured at day 1 and day 2
Primary SRD for Diffusion capacity for carbon monoxide (DLCOc) at rest SRD with 95% CI for DLCOc at rest Measured at day 1 and day 2
Primary SRD for DLCOc during exercise SRD with 95% CI for DLCOc during exercise Measured at day 1 and day 2
Primary SRD for membrane diffusing capacity (DM) at rest SRD with 95% CI for DM at rest Measured at day 1 and day 2
Primary SRD for DM during exercise SRD with 95% CI for DM during exercise Measured at day 1 and day 2
Primary SRD for Pulmonary blood volume (Vc) at rest SRD with 95% CI for Vc at rest Measured at day 1 and day 2
Primary SRD for Vc during exercise SRD with 95% CI for Vc during exercise Measured at day 1 and day 2
Primary SRD for alveolar volume (VA) at rest SRD with 95 % CI for VA at rest Measured at day 1 and day 2
Primary SRD for VA during exercise SRD with 95 % CI for VA during exercise Measured at day 1 and day 2
Primary Coefficient of Variance (CV) for DLNO at rest CV with a 95% CI at rest Measured at day 1 and day 2
Primary CV for DLNO during exercise CV with a 95% CI during exercise Measured at day 1 and day 2
Primary CV for DLCOc at rest CV with 95% CI for DLCOc at rest Measured at day 1 and day 2
Primary CV for DLCOc during exercise CV with 95% CI for DLCOc during exercise Measured at day 1 and day 2
Primary CV for DM at rest CV with 95% CI for DM at rest Measured at day 1 and day 2
Primary CV for DM during exercise CV with 95% CI for DM during exercise Measured at day 1 and day 2
Primary CV for Vc at rest CV with 95% CI for DM at rest Measured at day 1 and day 2
Primary CV for Vc during exercise CV with 95% CI for DM during exercise Measured at day 1 and day 2
Primary CV for VA at rest CV with 95% CI for VA at rest Measured at day 1 and day 2
Primary CV for VA during exercise CV with 95% CI for VA during exercise Measured at day 1 and day 2
Primary Intraclass correlation coefficient (ICC) for DLNO at rest ICC for DLNO with 95% CI at rest Measured at day 1 and day 2
Primary Intraclass correlation coefficient (ICC) for DLNO during exercise ICC for DLNO with 95% CI during exercise Measured at day 1 and day 2
Primary ICC for DLCOc at rest ICC for DLCOc with 95% CI at rest Measured at day 1 and day 2
Primary ICC for DLCOc during exercise ICC for DLCOc with 95% CI during exercise Measured at day 1 and day 2
Primary ICC for DM at rest ICC for DM with 95% CI at rest Measured at day 1 and day 2
Primary ICC for DM during exercise ICC for DM with 95% CI during exercise Measured at day 1 and day 2
Primary ICC for VC at rest ICC for VC with 95% CI at rest Measured at day 1 and day 2
Primary ICC for VC during exercise ICC for VC with 95% CI during exercise Measured at day 1 and day 2
Primary ICC for VA at rest ICC for VA with 95% CI at rest Measured at day 1 and day 2
Primary ICC for VA during exercise ICC for VA with 95% CI during exercise Measured at day 1 and day 2
Secondary Diffusion capacity for nitric oxide (DLNO) at rest DLNO at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Diffusion capacity for nitric oxide (DLNO) during exercise DLNO during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Diffusion capacity for carbon monoxide (DLCOc) at rest DLCOc at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Diffusion capacity for carbon monoxide (DLCOc) during exercise DLCOc during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Membrane diffusing capacity (DM) at rest DM at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Membrane diffusing capacity (DM) during exercise DM during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Pulmonary blood volume (Vc) at rest VC at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Pulmonary blood volume (Vc) during exercise VC during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Breath hold time at rest Breath hold time at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Breath hold time during exercise Breath hold time during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Alveolar volume (VA) at rest VA at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Alveolar volume (VA) during exercise VA during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold. Measured at day 1 and day 2
Secondary Bland Altman Plot - DLNO Bland Altman plot for repeated measures for DLNO Measured at day 1 and day 2
Secondary Bland Altman Plot - DLCOc Bland Altman plot for repeated measures for DLCOc Measured at day 1 and day 2
Secondary Bland Altman Plot - DM Bland Altman plot for repeated measures for DM Measured at day 1 and day 2
Secondary Bland Altman Plot - VC Bland Altman plot for repeated measures for VC Measured at day 1 and day 2
Secondary Bland Altman Plot - VA Bland Altman plot for repeated measures for VA Measured at day 1 and day 2
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