NCT05583396

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

October 13, 2022

Last Update Submit

November 17, 2022

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary diffusing capacityReliabilityTest-retest

Outcome Measures

Primary Outcomes (35)

  • 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 Outcomes (17)

  • Diffusion capacity for nitric oxide (DLNO) at rest

    Measured at day 1 and day 2

  • Diffusion capacity for nitric oxide (DLNO) during exercise

    Measured at day 1 and day 2

  • Diffusion capacity for carbon monoxide (DLCOc) at rest

    Measured at day 1 and day 2

  • Diffusion capacity for carbon monoxide (DLCOc) during exercise

    Measured at day 1 and day 2

  • Membrane diffusing capacity (DM) at rest

    Measured at day 1 and day 2

  • +12 more secondary outcomes

Other Outcomes (7)

  • Forced Expiratory Volume in 1 second (FEV1)

    Measured at baseline

  • Forced vital capacity (FVC)

    Measured at baseline

  • FEV1/FVC ratio

    Measured at baseline

  • +4 more other outcomes

Study Arms (1)

Acute exercise

OTHER

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

Interventions

Acute exerciseDIAGNOSTIC_TEST

The measurement will be repeated within one to seven days.

Acute exercise

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic obstructive pulmonary disease (GOLD II + III)

You may not qualify if:

  • Known heart disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Physical Activity Research (CFAS)

Copenhagen, 2100, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ronan Berg, MD

CONTACT

+45-35451825ronan.martin.griffin.berg@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc, Associate Professor, Principal investigator

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 17, 2022

Study Start

November 1, 2022

Primary Completion

May 1, 2023

Study Completion

August 1, 2023

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

The data will be openly available in a repository.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

DK(2)