Pulmonary Diffusing Capacity During Incremental Exercise in COPD

NCT06505902 | Completed

• 1 other identifier: H-24025935
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The combined measurement of pulmonary diffusing capacity for carbon monoxide (CO) and nitric oxide (NO) (DL,CO,NO) has recently been standardized and validated for clinical use. It involves a noticeably short breath-hold time (≤5 seconds), making it feasible to perform on patients with chronic obstructive pulmonary disease (COPD). These patients have lower diffusing capacity and are unable to increase it during exercise, which is thought to be caused by changes in pulmonary perfusion potentially leading to exertional dyspnea. The aim of the present study is to examine whether pulmonary diffusing capacity for incremental exercise differs between patients with COPD and matched healthy controls. Methods: Inclusion of 12 individuals with mild-to-severe COPD and 12 healthy age- and sex-matched controls. Design: Case-control study Intervention: DL,CO,NO and arterial blood gases will be measured during exercise at a bicycle ergometer at 0, 20, 40, 60 and 80% of the individual's maximal workload. Sample size: To detect a 15 mmol min-1 kPa-1 difference in DL,NO between groups at 60% of maximal workload, with a power of 90% and a significance level of 0.05, at least 12 subjects are required in each group. To account for potential dropouts, power will be permitted to decrease to 80%, corresponding to a total of 10 subjects in each group. Statistical design: Linear mixed effect model and pairwise testing of estimated marginal means. Perspective: This study will add to the understanding exertional dyspnoea in patients with COPD.

Conditions

COPD; Healthy; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  Between-group difference in the change in DL,NO from rest to exercise as a function of workload

  Measured at day 2

Secondary Outcomes (22)

• Key secondary outcome

  Measured at day 2

• Other secondary outcome

  Measured at day 2

• Other secondary outcome

  Measured at day 2

• Other secondary outcome

  Measured at day 2

• Other secondary outcome

  Measured at day 2

Other Outcomes (13)

• Exploratory outcomes

  Measured at day 2

• Exploratory outcomes

  Measured at day 2

• Exploratory outcomes

  Measured at day 2

Study Arms (2)

COPD-patients

EXPERIMENTAL

COPD-patients during diffusing capacity measurement during incremental exercise

Other: Exercise

Matched healthy volunteers

EXPERIMENTAL

Healthy matched controls during diffusing capacity measurement during incremental exercise

Other: Exercise

Interventions

Exercise OTHER

Exercise by bicycle and performing diffusing capacity measurements at the same time with arterial blood gasses.

COPD-patients; Matched healthy volunteers

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• years
• Mild to severe COPD (GOLD stage I to IIII)
• Men and women
• Age +/- 3 years of an included COPD patient

You may not qualify if:

• Known ischaemic heart disease
• Known heart failure
• Cardiac arrythmias
• Dementia or other severe neurological disease
• Known vascular ischaemic disease
• Symptoms of infection (bacterial/viral) within 2 weeks prior to the study
• Pregnancy
• COPD
• Known ischaemic heart disease
• Known heart failure
• Cardiac arrythmias
• Dementia or other severe neurological disease
• Known vascular ischaemic disease
• Symptoms of infection (bacterial/viral) within 2 weeks prior to the study
• Pregnancy

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Center for Aktiv Sundhed (CFAS), Rigshospitalet, Copenhagen, Denmark.

Copenhagen, København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Milan Mohammad, MD

  Centre for Physical Activity Research, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator, PhD-student at the Department of Physical Activity Research center, Copenhagen, Denmark.

Model Details: Matched case-control study

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 17, 2024
• Study Start: July 15, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

DK (1)