Pulmonary Diffusing Capacity During Acute Exercise in Patients With COPD

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Diagnostic Test: Acute exercise

• Registration Number: NCT05583396
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Status Verified: 2022-11
• Study Start: 2022-11-01
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-21
• Primary Completion: 2023-05-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Chronic obstructive pulmonary disease (GOLD II + III)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute exercise	Acute exercise	Pulmonary diffusing capacity using the DLCO/NO technique is assessed at rest and during exercise (60% of maximal workload on a bicycle ergometer)

Primary Outcome Measures

Name	Time	Method
CV for VA during exercise	Measured at day 1 and day 2	CV with 95% CI for VA during exercise
Rest-to-exercise change in DLNO	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 DM	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.
CV for DM at rest	Measured at day 1 and day 2	CV with 95% CI for DM at rest
CV for VA at rest	Measured at day 1 and day 2	CV with 95% CI for VA at rest
SRD for Diffusion capacity for carbon monoxide (DLCOc) at rest	Measured at day 1 and day 2	SRD with 95% CI for DLCOc at rest
Rest-to-exercise change in VC	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	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.
SRD for DLNO during exercise	Measured at day 1 and day 2	SRD with 95% CI for DLNO during exercise
SRD for DLCOc during exercise	Measured at day 1 and day 2	SRD with 95% CI for DLCOc during exercise
SRD for Pulmonary blood volume (Vc) at rest	Measured at day 1 and day 2	SRD with 95% CI for Vc at rest
SRD for VA during exercise	Measured at day 1 and day 2	SRD with 95 % CI for VA during exercise
CV for DLNO during exercise	Measured at day 1 and day 2	CV with a 95% CI during exercise
CV for DLCOc during exercise	Measured at day 1 and day 2	CV with 95% CI for DLCOc during exercise
CV for DM during exercise	Measured at day 1 and day 2	CV with 95% CI for DM during exercise
CV for Vc at rest	Measured at day 1 and day 2	CV with 95% CI for DM at rest
CV for Vc during exercise	Measured at day 1 and day 2	CV with 95% CI for DM during exercise
Intraclass correlation coefficient (ICC) for DLNO at rest	Measured at day 1 and day 2	ICC for DLNO with 95% CI at rest
Rest-to-exercise change in DLCOc	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.
Smallest real difference (SRD) for Diffusion capacity for DLNO at rest	Measured at day 1 and day 2	SRD with 95 % confidence intervals (95% CI) for DLNO at rest
SRD for membrane diffusing capacity (DM) at rest	Measured at day 1 and day 2	SRD with 95% CI for DM at rest
SRD for DM during exercise	Measured at day 1 and day 2	SRD with 95% CI for DM during exercise
SRD for Vc during exercise	Measured at day 1 and day 2	SRD with 95% CI for Vc during exercise
SRD for alveolar volume (VA) at rest	Measured at day 1 and day 2	SRD with 95 % CI for VA at rest
Coefficient of Variance (CV) for DLNO at rest	Measured at day 1 and day 2	CV with a 95% CI at rest
CV for DLCOc at rest	Measured at day 1 and day 2	CV with 95% CI for DLCOc at rest
ICC for DLCOc at rest	Measured at day 1 and day 2	ICC for DLCOc with 95% CI at rest
ICC for VC at rest	Measured at day 1 and day 2	ICC for VC with 95% CI at rest
Intraclass correlation coefficient (ICC) for DLNO during exercise	Measured at day 1 and day 2	ICC for DLNO with 95% CI during exercise
ICC for DLCOc during exercise	Measured at day 1 and day 2	ICC for DLCOc with 95% CI during exercise
ICC for DM at rest	Measured at day 1 and day 2	ICC for DM with 95% CI at rest
ICC for VC during exercise	Measured at day 1 and day 2	ICC for VC with 95% CI during exercise
ICC for VA during exercise	Measured at day 1 and day 2	ICC for VA with 95% CI during exercise
ICC for DM during exercise	Measured at day 1 and day 2	ICC for DM with 95% CI during exercise
ICC for VA at rest	Measured at day 1 and day 2	ICC for VA with 95% CI at rest

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Centre for Physical Activity Research (CFAS); 🇩🇰 Copenhagen, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark