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DiffLung2: Pulmonary Diffusing Capacity During Acute Exercise in Patients With COPD

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT05583396
Collaborator
(none)
15
Enrollment
2
Locations
1
Arm
9
Anticipated Duration (Months)
7.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Acute exercise
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. SRD for DLNO during exercise [Measured at day 1 and day 2]

    SRD with 95% CI for DLNO during exercise

  8. 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

  9. SRD for DLCOc during exercise [Measured at day 1 and day 2]

    SRD with 95% CI for DLCOc during exercise

  10. SRD for membrane diffusing capacity (DM) at rest [Measured at day 1 and day 2]

    SRD with 95% CI for DM at rest

  11. SRD for DM during exercise [Measured at day 1 and day 2]

    SRD with 95% CI for DM during exercise

  12. SRD for Pulmonary blood volume (Vc) at rest [Measured at day 1 and day 2]

    SRD with 95% CI for Vc at rest

  13. SRD for Vc during exercise [Measured at day 1 and day 2]

    SRD with 95% CI for Vc during exercise

  14. SRD for alveolar volume (VA) at rest [Measured at day 1 and day 2]

    SRD with 95 % CI for VA at rest

  15. SRD for VA during exercise [Measured at day 1 and day 2]

    SRD with 95 % CI for VA during exercise

  16. Coefficient of Variance (CV) for DLNO at rest [Measured at day 1 and day 2]

    CV with a 95% CI at rest

  17. CV for DLNO during exercise [Measured at day 1 and day 2]

    CV with a 95% CI during exercise

  18. CV for DLCOc at rest [Measured at day 1 and day 2]

    CV with 95% CI for DLCOc at rest

  19. CV for DLCOc during exercise [Measured at day 1 and day 2]

    CV with 95% CI for DLCOc during exercise

  20. CV for DM at rest [Measured at day 1 and day 2]

    CV with 95% CI for DM at rest

  21. CV for DM during exercise [Measured at day 1 and day 2]

    CV with 95% CI for DM during exercise

  22. CV for Vc at rest [Measured at day 1 and day 2]

    CV with 95% CI for DM at rest

  23. CV for Vc during exercise [Measured at day 1 and day 2]

    CV with 95% CI for DM during exercise

  24. CV for VA at rest [Measured at day 1 and day 2]

    CV with 95% CI for VA at rest

  25. CV for VA during exercise [Measured at day 1 and day 2]

    CV with 95% CI for VA during exercise

  26. Intraclass correlation coefficient (ICC) for DLNO at rest [Measured at day 1 and day 2]

    ICC for DLNO with 95% CI at rest

  27. Intraclass correlation coefficient (ICC) for DLNO during exercise [Measured at day 1 and day 2]

    ICC for DLNO with 95% CI during exercise

  28. ICC for DLCOc at rest [Measured at day 1 and day 2]

    ICC for DLCOc with 95% CI at rest

  29. ICC for DLCOc during exercise [Measured at day 1 and day 2]

    ICC for DLCOc with 95% CI during exercise

  30. ICC for DM at rest [Measured at day 1 and day 2]

    ICC for DM with 95% CI at rest

  31. ICC for DM during exercise [Measured at day 1 and day 2]

    ICC for DM with 95% CI during exercise

  32. ICC for VC at rest [Measured at day 1 and day 2]

    ICC for VC with 95% CI at rest

  33. ICC for VC during exercise [Measured at day 1 and day 2]

    ICC for VC with 95% CI during exercise

  34. ICC for VA at rest [Measured at day 1 and day 2]

    ICC for VA with 95% CI at rest

  35. ICC for VA during exercise [Measured at day 1 and day 2]

    ICC for VA with 95% CI during exercise

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Bland Altman Plot - DLNO [Measured at day 1 and day 2]

    Bland Altman plot for repeated measures for DLNO

  14. Bland Altman Plot - DLCOc [Measured at day 1 and day 2]

    Bland Altman plot for repeated measures for DLCOc

  15. Bland Altman Plot - DM [Measured at day 1 and day 2]

    Bland Altman plot for repeated measures for DM

  16. Bland Altman Plot - VC [Measured at day 1 and day 2]

    Bland Altman plot for repeated measures for VC

  17. Bland Altman Plot - VA [Measured at day 1 and day 2]

    Bland Altman plot for repeated measures for VA

Other Outcome Measures

  1. Forced Expiratory Volume in 1 second (FEV1) [Measured at baseline]

    FEV1 measured during dynamic spirometry, and expressed as liter and percentage of predicted.

  2. Forced vital capacity (FVC) [Measured at baseline]

    FVC measured during dynamic spirometry, and expressed as liter and percentage of predicted.

  3. FEV1/FVC ratio [Measured at baseline]

    FEV1/FVC measured during dynamic spirometry, and expressed as liter and percentage of predicted.

  4. Residual Volume (RV) [Measured at baseline]

    RV measured with whole-body plethysmography, and expressed as liter and percentage of predicted.

  5. Total Lung Capacity (TLC) [Measured at baseline]

    TLC measured with whole-body plethysmography, and expressed as liter and percentage of predicted.

  6. Diffusion capacity for carbon monoxide corrected for hemoglobin [Measured at baseline]

    DLCOc measured and expressed as mmol/(min*kPa) and percentage of predicted.

  7. Peak oxygen consumption (VO2peak) [Measured at baseline]

    VO2peak test performed on a Monark ergometer bicycle.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Chronic obstructive pulmonary disease (GOLD II + III)
Exclusion Criteria:

  • Known heart disease

  • Pregnancy

  • Disease within two weeks prior to inclusion

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Physical Activity Research (CFAS) Copenhagen Denmark 2100
2 Rigshospitalet Copenhagen Denmark 2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ronan Berg, MD, DMSc, Associate Professor, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT05583396
Other Study ID Numbers:
  • DiffLung2
First Posted:
Oct 17, 2022
Last Update Posted:
Nov 21, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ronan Berg, MD, DMSc, Associate Professor, Principal investigator, Rigshospitalet, Denmark
Pulmonary diffusing capacity
Reliability
Test-retest
Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Nov 21, 2022