Pulmonary Diffusing Capacity During Acute Exercise in Patients With COPD (DiffLung2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Diagnostic test: Acute exercise

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronan Berg, MD; Phone Number: +45-35451825; Email: ronan.martin.griffin.berg@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
    • Principal Investigator: Stine Nymand, Cand.Scient
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Centre for Physical Activity Research (CFAS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic obstructive pulmonary disease (GOLD II + III)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)	Diagnostic test: Acute exercise; The measurement will be repeated within one to seven days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
SRD for DLNO during exercise	SRD with 95% CI for DLNO during exercise	Measured at day 1 and day 2
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
SRD for DLCOc during exercise	SRD with 95% CI for DLCOc during exercise	Measured at day 1 and day 2
SRD for membrane diffusing capacity (DM) at rest	SRD with 95% CI for DM at rest	Measured at day 1 and day 2
SRD for DM during exercise	SRD with 95% CI for DM during exercise	Measured at day 1 and day 2
SRD for Pulmonary blood volume (Vc) at rest	SRD with 95% CI for Vc at rest	Measured at day 1 and day 2
SRD for Vc during exercise	SRD with 95% CI for Vc during exercise	Measured at day 1 and day 2
SRD for alveolar volume (VA) at rest	SRD with 95 % CI for VA at rest	Measured at day 1 and day 2
SRD for VA during exercise	SRD with 95 % CI for VA during exercise	Measured at day 1 and day 2
Coefficient of Variance (CV) for DLNO at rest	CV with a 95% CI at rest	Measured at day 1 and day 2
CV for DLNO during exercise	CV with a 95% CI during exercise	Measured at day 1 and day 2
CV for DLCOc at rest	CV with 95% CI for DLCOc at rest	Measured at day 1 and day 2
CV for DLCOc during exercise	CV with 95% CI for DLCOc during exercise	Measured at day 1 and day 2
CV for DM at rest	CV with 95% CI for DM at rest	Measured at day 1 and day 2
CV for DM during exercise	CV with 95% CI for DM during exercise	Measured at day 1 and day 2
CV for Vc at rest	CV with 95% CI for DM at rest	Measured at day 1 and day 2
CV for Vc during exercise	CV with 95% CI for DM during exercise	Measured at day 1 and day 2
CV for VA at rest	CV with 95% CI for VA at rest	Measured at day 1 and day 2
CV for VA during exercise	CV with 95% CI for VA during exercise	Measured at day 1 and day 2
Intraclass correlation coefficient (ICC) for DLNO at rest	ICC for DLNO with 95% CI at rest	Measured at day 1 and day 2
Intraclass correlation coefficient (ICC) for DLNO during exercise	ICC for DLNO with 95% CI during exercise	Measured at day 1 and day 2
ICC for DLCOc at rest	ICC for DLCOc with 95% CI at rest	Measured at day 1 and day 2
ICC for DLCOc during exercise	ICC for DLCOc with 95% CI during exercise	Measured at day 1 and day 2
ICC for DM at rest	ICC for DM with 95% CI at rest	Measured at day 1 and day 2
ICC for DM during exercise	ICC for DM with 95% CI during exercise	Measured at day 1 and day 2
ICC for VC at rest	ICC for VC with 95% CI at rest	Measured at day 1 and day 2
ICC for VC during exercise	ICC for VC with 95% CI during exercise	Measured at day 1 and day 2
ICC for VA at rest	ICC for VA with 95% CI at rest	Measured at day 1 and day 2
ICC for VA during exercise	ICC for VA with 95% CI during exercise	Measured at day 1 and day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
Bland Altman Plot - DLNO	Bland Altman plot for repeated measures for DLNO	Measured at day 1 and day 2
Bland Altman Plot - DLCOc	Bland Altman plot for repeated measures for DLCOc	Measured at day 1 and day 2
Bland Altman Plot - DM	Bland Altman plot for repeated measures for DM	Measured at day 1 and day 2
Bland Altman Plot - VC	Bland Altman plot for repeated measures for VC	Measured at day 1 and day 2
Bland Altman Plot - VA	Bland Altman plot for repeated measures for VA	Measured at day 1 and day 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in 1 second (FEV1)	FEV1 measured during dynamic spirometry, and expressed as liter and percentage of predicted.	Measured at baseline
Forced vital capacity (FVC)	FVC measured during dynamic spirometry, and expressed as liter and percentage of predicted.	Measured at baseline
FEV1/FVC ratio	FEV1/FVC measured during dynamic spirometry, and expressed as liter and percentage of predicted.	Measured at baseline
Residual Volume (RV)	RV measured with whole-body plethysmography, and expressed as liter and percentage of predicted.	Measured at baseline
Total Lung Capacity (TLC)	TLC measured with whole-body plethysmography, and expressed as liter and percentage of predicted.	Measured at baseline
Diffusion capacity for carbon monoxide corrected for hemoglobin	DLCOc measured and expressed as mmol/(min*kPa) and percentage of predicted.	Measured at baseline
Peak oxygen consumption (VO2peak)	VO2peak test performed on a Monark ergometer bicycle.	Measured at baseline

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Reliability; Test-retest; Pulmonary diffusing capacity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: DiffLung2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data will be openly available in a repository.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No