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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Acute exercise
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring Pulmonary diffusing capacity, Reliability, Test-retest

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic obstructive pulmonary disease (GOLD II + III)

Exclusion Criteria:

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

Sites / Locations

  • Centre for Physical Activity Research (CFAS)Recruiting
  • RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Acute exercise

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Smallest real difference (SRD) for Diffusion capacity for DLNO at rest
SRD with 95 % confidence intervals (95% CI) for DLNO at rest
SRD for DLNO during exercise
SRD with 95% CI for DLNO during exercise
SRD for Diffusion capacity for carbon monoxide (DLCOc) at rest
SRD with 95% CI for DLCOc at rest
SRD for DLCOc during exercise
SRD with 95% CI for DLCOc during exercise
SRD for membrane diffusing capacity (DM) at rest
SRD with 95% CI for DM at rest
SRD for DM during exercise
SRD with 95% CI for DM during exercise
SRD for Pulmonary blood volume (Vc) at rest
SRD with 95% CI for Vc at rest
SRD for Vc during exercise
SRD with 95% CI for Vc during exercise
SRD for alveolar volume (VA) at rest
SRD with 95 % CI for VA at rest
SRD for VA during exercise
SRD with 95 % CI for VA during exercise
Coefficient of Variance (CV) for DLNO at rest
CV with a 95% CI at rest
CV for DLNO during exercise
CV with a 95% CI during exercise
CV for DLCOc at rest
CV with 95% CI for DLCOc at rest
CV for DLCOc during exercise
CV with 95% CI for DLCOc during exercise
CV for DM at rest
CV with 95% CI for DM at rest
CV for DM during exercise
CV with 95% CI for DM during exercise
CV for Vc at rest
CV with 95% CI for DM at rest
CV for Vc during exercise
CV with 95% CI for DM during exercise
CV for VA at rest
CV with 95% CI for VA at rest
CV for VA during exercise
CV with 95% CI for VA during exercise
Intraclass correlation coefficient (ICC) for DLNO at rest
ICC for DLNO with 95% CI at rest
Intraclass correlation coefficient (ICC) for DLNO during exercise
ICC for DLNO with 95% CI during exercise
ICC for DLCOc at rest
ICC for DLCOc with 95% CI at rest
ICC for DLCOc during exercise
ICC for DLCOc with 95% CI during exercise
ICC for DM at rest
ICC for DM with 95% CI at rest
ICC for DM during exercise
ICC for DM with 95% CI during exercise
ICC for VC at rest
ICC for VC with 95% CI at rest
ICC for VC during exercise
ICC for VC with 95% CI during exercise
ICC for VA at rest
ICC for VA with 95% CI at rest
ICC for VA during exercise
ICC for VA with 95% CI during exercise

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2022
Last Updated
November 17, 2022
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05583396
Brief Title
Pulmonary Diffusing Capacity During Acute Exercise in Patients With COPD
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Pulmonary diffusing capacity, Reliability, Test-retest

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute exercise
Arm Type
Other
Arm Description
Pulmonary diffusing capacity using the DLCO/NO technique is assessed at rest and during exercise (60% of maximal workload on a bicycle ergometer)
Intervention Type
Diagnostic Test
Intervention Name(s)
Acute exercise
Intervention Description
The measurement will be repeated within one to seven days.
Primary Outcome Measure Information:
Title
Rest-to-exercise change in DLNO
Description
The physiological change from rest to exercise in DLNO obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Rest-to-exercise change in DLCOc
Description
The physiological change from rest to exercise in DLCOc obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Rest-to-exercise change in DM
Description
The physiological change from rest to exercise in DM obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Rest-to-exercise change in VC
Description
The physiological change from rest to exercise in VC obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Rest-to-exercise change in VA
Description
The physiological change from rest to exercise in VA obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Smallest real difference (SRD) for Diffusion capacity for DLNO at rest
Description
SRD with 95 % confidence intervals (95% CI) for DLNO at rest
Time Frame
Measured at day 1 and day 2
Title
SRD for DLNO during exercise
Description
SRD with 95% CI for DLNO during exercise
Time Frame
Measured at day 1 and day 2
Title
SRD for Diffusion capacity for carbon monoxide (DLCOc) at rest
Description
SRD with 95% CI for DLCOc at rest
Time Frame
Measured at day 1 and day 2
Title
SRD for DLCOc during exercise
Description
SRD with 95% CI for DLCOc during exercise
Time Frame
Measured at day 1 and day 2
Title
SRD for membrane diffusing capacity (DM) at rest
Description
SRD with 95% CI for DM at rest
Time Frame
Measured at day 1 and day 2
Title
SRD for DM during exercise
Description
SRD with 95% CI for DM during exercise
Time Frame
Measured at day 1 and day 2
Title
SRD for Pulmonary blood volume (Vc) at rest
Description
SRD with 95% CI for Vc at rest
Time Frame
Measured at day 1 and day 2
Title
SRD for Vc during exercise
Description
SRD with 95% CI for Vc during exercise
Time Frame
Measured at day 1 and day 2
Title
SRD for alveolar volume (VA) at rest
Description
SRD with 95 % CI for VA at rest
Time Frame
Measured at day 1 and day 2
Title
SRD for VA during exercise
Description
SRD with 95 % CI for VA during exercise
Time Frame
Measured at day 1 and day 2
Title
Coefficient of Variance (CV) for DLNO at rest
Description
CV with a 95% CI at rest
Time Frame
Measured at day 1 and day 2
Title
CV for DLNO during exercise
Description
CV with a 95% CI during exercise
Time Frame
Measured at day 1 and day 2
Title
CV for DLCOc at rest
Description
CV with 95% CI for DLCOc at rest
Time Frame
Measured at day 1 and day 2
Title
CV for DLCOc during exercise
Description
CV with 95% CI for DLCOc during exercise
Time Frame
Measured at day 1 and day 2
Title
CV for DM at rest
Description
CV with 95% CI for DM at rest
Time Frame
Measured at day 1 and day 2
Title
CV for DM during exercise
Description
CV with 95% CI for DM during exercise
Time Frame
Measured at day 1 and day 2
Title
CV for Vc at rest
Description
CV with 95% CI for DM at rest
Time Frame
Measured at day 1 and day 2
Title
CV for Vc during exercise
Description
CV with 95% CI for DM during exercise
Time Frame
Measured at day 1 and day 2
Title
CV for VA at rest
Description
CV with 95% CI for VA at rest
Time Frame
Measured at day 1 and day 2
Title
CV for VA during exercise
Description
CV with 95% CI for VA during exercise
Time Frame
Measured at day 1 and day 2
Title
Intraclass correlation coefficient (ICC) for DLNO at rest
Description
ICC for DLNO with 95% CI at rest
Time Frame
Measured at day 1 and day 2
Title
Intraclass correlation coefficient (ICC) for DLNO during exercise
Description
ICC for DLNO with 95% CI during exercise
Time Frame
Measured at day 1 and day 2
Title
ICC for DLCOc at rest
Description
ICC for DLCOc with 95% CI at rest
Time Frame
Measured at day 1 and day 2
Title
ICC for DLCOc during exercise
Description
ICC for DLCOc with 95% CI during exercise
Time Frame
Measured at day 1 and day 2
Title
ICC for DM at rest
Description
ICC for DM with 95% CI at rest
Time Frame
Measured at day 1 and day 2
Title
ICC for DM during exercise
Description
ICC for DM with 95% CI during exercise
Time Frame
Measured at day 1 and day 2
Title
ICC for VC at rest
Description
ICC for VC with 95% CI at rest
Time Frame
Measured at day 1 and day 2
Title
ICC for VC during exercise
Description
ICC for VC with 95% CI during exercise
Time Frame
Measured at day 1 and day 2
Title
ICC for VA at rest
Description
ICC for VA with 95% CI at rest
Time Frame
Measured at day 1 and day 2
Title
ICC for VA during exercise
Description
ICC for VA with 95% CI during exercise
Time Frame
Measured at day 1 and day 2
Secondary Outcome Measure Information:
Title
Diffusion capacity for nitric oxide (DLNO) at rest
Description
DLNO at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Diffusion capacity for nitric oxide (DLNO) during exercise
Description
DLNO during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Diffusion capacity for carbon monoxide (DLCOc) at rest
Description
DLCOc at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Diffusion capacity for carbon monoxide (DLCOc) during exercise
Description
DLCOc during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Membrane diffusing capacity (DM) at rest
Description
DM at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Membrane diffusing capacity (DM) during exercise
Description
DM during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Pulmonary blood volume (Vc) at rest
Description
VC at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Pulmonary blood volume (Vc) during exercise
Description
VC during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Breath hold time at rest
Description
Breath hold time at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Breath hold time during exercise
Description
Breath hold time during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Alveolar volume (VA) at rest
Description
VA at rest obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Alveolar volume (VA) during exercise
Description
VA during exercise obtained using the combined DLCO/NO technique with a 5-sec breathhold.
Time Frame
Measured at day 1 and day 2
Title
Bland Altman Plot - DLNO
Description
Bland Altman plot for repeated measures for DLNO
Time Frame
Measured at day 1 and day 2
Title
Bland Altman Plot - DLCOc
Description
Bland Altman plot for repeated measures for DLCOc
Time Frame
Measured at day 1 and day 2
Title
Bland Altman Plot - DM
Description
Bland Altman plot for repeated measures for DM
Time Frame
Measured at day 1 and day 2
Title
Bland Altman Plot - VC
Description
Bland Altman plot for repeated measures for VC
Time Frame
Measured at day 1 and day 2
Title
Bland Altman Plot - VA
Description
Bland Altman plot for repeated measures for VA
Time Frame
Measured at day 1 and day 2
Other Pre-specified Outcome Measures:
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
FEV1 measured during dynamic spirometry, and expressed as liter and percentage of predicted.
Time Frame
Measured at baseline
Title
Forced vital capacity (FVC)
Description
FVC measured during dynamic spirometry, and expressed as liter and percentage of predicted.
Time Frame
Measured at baseline
Title
FEV1/FVC ratio
Description
FEV1/FVC measured during dynamic spirometry, and expressed as liter and percentage of predicted.
Time Frame
Measured at baseline
Title
Residual Volume (RV)
Description
RV measured with whole-body plethysmography, and expressed as liter and percentage of predicted.
Time Frame
Measured at baseline
Title
Total Lung Capacity (TLC)
Description
TLC measured with whole-body plethysmography, and expressed as liter and percentage of predicted.
Time Frame
Measured at baseline
Title
Diffusion capacity for carbon monoxide corrected for hemoglobin
Description
DLCOc measured and expressed as mmol/(min*kPa) and percentage of predicted.
Time Frame
Measured at baseline
Title
Peak oxygen consumption (VO2peak)
Description
VO2peak test performed on a Monark ergometer bicycle.
Time Frame
Measured at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic obstructive pulmonary disease (GOLD II + III) Exclusion Criteria: Known heart disease Pregnancy Disease within two weeks prior to inclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronan Berg, MD
Phone
+45-35451825
Email
ronan.martin.griffin.berg@regionh.dk
Facility Information:
Facility Name
Centre for Physical Activity Research (CFAS)
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Peter Hartmann, MD
Phone
40924285
Email
jacob.peter.okholm.hartmann.01@regionh.dk
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronan Berg, MD
Phone
+45-35451825
Email
ronan@sund.ku.dk
First Name & Middle Initial & Last Name & Degree
Regitse Christensen, MD
Phone
+45-35451825
Email
Regitse.Hoejgaard.Christensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Stine Nymand, Cand.Scient

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be openly available in a repository.

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Pulmonary Diffusing Capacity During Acute Exercise in Patients With COPD

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