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

November 17, 2022 updated by: Ronan Berg, Rigshospitalet, Denmark

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rest-to-exercise change in DLNO
Time Frame: 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.
Measured at day 1 and day 2
Rest-to-exercise change in DLCOc
Time Frame: 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.
Measured at day 1 and day 2
Rest-to-exercise change in DM
Time Frame: 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.
Measured at day 1 and day 2
Rest-to-exercise change in VC
Time Frame: 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.
Measured at day 1 and day 2
Rest-to-exercise change in VA
Time Frame: 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.
Measured at day 1 and day 2
Smallest real difference (SRD) for Diffusion capacity for DLNO at rest
Time Frame: Measured at day 1 and day 2
SRD with 95 % confidence intervals (95% CI) for DLNO at rest
Measured at day 1 and day 2
SRD for DLNO during exercise
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
SRD with 95% CI for DLCOc at rest
Measured at day 1 and day 2
SRD for DLCOc during exercise
Time Frame: Measured at day 1 and day 2
SRD with 95% CI for DLCOc during exercise
Measured at day 1 and day 2
SRD for membrane diffusing capacity (DM) at rest
Time Frame: Measured at day 1 and day 2
SRD with 95% CI for DM at rest
Measured at day 1 and day 2
SRD for DM during exercise
Time Frame: Measured at day 1 and day 2
SRD with 95% CI for DM during exercise
Measured at day 1 and day 2
SRD for Pulmonary blood volume (Vc) at rest
Time Frame: Measured at day 1 and day 2
SRD with 95% CI for Vc at rest
Measured at day 1 and day 2
SRD for Vc during exercise
Time Frame: Measured at day 1 and day 2
SRD with 95% CI for Vc during exercise
Measured at day 1 and day 2
SRD for alveolar volume (VA) at rest
Time Frame: Measured at day 1 and day 2
SRD with 95 % CI for VA at rest
Measured at day 1 and day 2
SRD for VA during exercise
Time Frame: Measured at day 1 and day 2
SRD with 95 % CI for VA during exercise
Measured at day 1 and day 2
Coefficient of Variance (CV) for DLNO at rest
Time Frame: Measured at day 1 and day 2
CV with a 95% CI at rest
Measured at day 1 and day 2
CV for DLNO during exercise
Time Frame: Measured at day 1 and day 2
CV with a 95% CI during exercise
Measured at day 1 and day 2
CV for DLCOc at rest
Time Frame: Measured at day 1 and day 2
CV with 95% CI for DLCOc at rest
Measured at day 1 and day 2
CV for DLCOc during exercise
Time Frame: Measured at day 1 and day 2
CV with 95% CI for DLCOc during exercise
Measured at day 1 and day 2
CV for DM at rest
Time Frame: Measured at day 1 and day 2
CV with 95% CI for DM at rest
Measured at day 1 and day 2
CV for DM during exercise
Time Frame: Measured at day 1 and day 2
CV with 95% CI for DM during exercise
Measured at day 1 and day 2
CV for Vc at rest
Time Frame: Measured at day 1 and day 2
CV with 95% CI for DM at rest
Measured at day 1 and day 2
CV for Vc during exercise
Time Frame: Measured at day 1 and day 2
CV with 95% CI for DM during exercise
Measured at day 1 and day 2
CV for VA at rest
Time Frame: Measured at day 1 and day 2
CV with 95% CI for VA at rest
Measured at day 1 and day 2
CV for VA during exercise
Time Frame: Measured at day 1 and day 2
CV with 95% CI for VA during exercise
Measured at day 1 and day 2
Intraclass correlation coefficient (ICC) for DLNO at rest
Time Frame: Measured at day 1 and day 2
ICC for DLNO with 95% CI at rest
Measured at day 1 and day 2
Intraclass correlation coefficient (ICC) for DLNO during exercise
Time Frame: Measured at day 1 and day 2
ICC for DLNO with 95% CI during exercise
Measured at day 1 and day 2
ICC for DLCOc at rest
Time Frame: Measured at day 1 and day 2
ICC for DLCOc with 95% CI at rest
Measured at day 1 and day 2
ICC for DLCOc during exercise
Time Frame: Measured at day 1 and day 2
ICC for DLCOc with 95% CI during exercise
Measured at day 1 and day 2
ICC for DM at rest
Time Frame: Measured at day 1 and day 2
ICC for DM with 95% CI at rest
Measured at day 1 and day 2
ICC for DM during exercise
Time Frame: Measured at day 1 and day 2
ICC for DM with 95% CI during exercise
Measured at day 1 and day 2
ICC for VC at rest
Time Frame: Measured at day 1 and day 2
ICC for VC with 95% CI at rest
Measured at day 1 and day 2
ICC for VC during exercise
Time Frame: Measured at day 1 and day 2
ICC for VC with 95% CI during exercise
Measured at day 1 and day 2
ICC for VA at rest
Time Frame: Measured at day 1 and day 2
ICC for VA with 95% CI at rest
Measured at day 1 and day 2
ICC for VA during exercise
Time Frame: Measured at day 1 and day 2
ICC for VA with 95% CI during exercise
Measured at day 1 and day 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diffusion capacity for nitric oxide (DLNO) at rest
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
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
Time Frame: Measured at day 1 and day 2
Bland Altman plot for repeated measures for DLNO
Measured at day 1 and day 2
Bland Altman Plot - DLCOc
Time Frame: Measured at day 1 and day 2
Bland Altman plot for repeated measures for DLCOc
Measured at day 1 and day 2
Bland Altman Plot - DM
Time Frame: Measured at day 1 and day 2
Bland Altman plot for repeated measures for DM
Measured at day 1 and day 2
Bland Altman Plot - VC
Time Frame: Measured at day 1 and day 2
Bland Altman plot for repeated measures for VC
Measured at day 1 and day 2
Bland Altman Plot - VA
Time Frame: Measured at day 1 and day 2
Bland Altman plot for repeated measures for VA
Measured at day 1 and day 2

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: Measured at baseline
FEV1 measured during dynamic spirometry, and expressed as liter and percentage of predicted.
Measured at baseline
Forced vital capacity (FVC)
Time Frame: Measured at baseline
FVC measured during dynamic spirometry, and expressed as liter and percentage of predicted.
Measured at baseline
FEV1/FVC ratio
Time Frame: Measured at baseline
FEV1/FVC measured during dynamic spirometry, and expressed as liter and percentage of predicted.
Measured at baseline
Residual Volume (RV)
Time Frame: Measured at baseline
RV measured with whole-body plethysmography, and expressed as liter and percentage of predicted.
Measured at baseline
Total Lung Capacity (TLC)
Time Frame: Measured at baseline
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
Time Frame: Measured at baseline
DLCOc measured and expressed as mmol/(min*kPa) and percentage of predicted.
Measured at baseline
Peak oxygen consumption (VO2peak)
Time Frame: Measured at baseline
VO2peak test performed on a Monark ergometer bicycle.
Measured at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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