Pulmonary Diffusing Capacity During Acute Exercise in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— DiffLung2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583396
• Other study ID #: DiffLung2
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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