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Clinical Trials/NCT06287476
NCT06287476CompletedNot Applicable

Alveolar-capillary Reserve After Exercise in COPD

Rigshospitalet, Denmark1 site in 1 country32 target enrollmentStarted: May 6, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
1
Primary Endpoint
Rest-to-exercise pulmonary DTPA clearance change after exercise in COPD vs. controls

Study Overview

Brief Summary

It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass.

Detailed Description

It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass. The study participants include a control group and a group with COPD (GOLD I-III). Participants are undergoing three study days: (1) Measurement of maximal aerobic capacity and lung function test, (2) lung tissue mass and alveolar-capillary permeability is measured at rest and again 2 hours later, immediately after the participant has exercised on a bicycle ergometer and (3) supine cardiac output and pulmonary capillary blood volume will be measured at rest and immediately after exercise.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
45 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •individuals with COPD
  • •Men and women
  • •45-80 years old
  • •COPD (GOLD stage I to III)
  • •Resting arterial oxygenation > 90%
  • •Inclusion criteria - healthy controls
  • •Men and women
  • •45-80 years old
  • •Non-smokers
  • •Normal lung function
  • •Same sex, age (± 3 years) as the COPD group

Exclusion Criteria

  • •individuals with COPD
  • •Symptoms of ischemic heart disease
  • •Known heart failure
  • •Symptoms of illness, including fever, within 2 weeks prior to the study
  • •Pregnancy
  • •• Known renal or liver diseaseActive smoking (within 3 weeks)
  • •Exclusion criteria - healthy controls
  • •Known chronic lung disease
  • •Symptoms of ischemic heart disease
  • •Known heart failure
  • •Symptoms of illness, including fever, within 2 weeks prior to the study
  • •Pregnancy
  • •Known renal or liver disease
  • •Active smoking (within 3 weeks)

Arms & Interventions

Control Group

Experimental

This arm consist of only healthy participants (age (+/- 3 years) and sex matched to the COPD group), which will undergo three study visits

Intervention: Acute exercise bout on visit 2 and 3 (Other)

COPD group

Experimental

This arm consist of only COPD patients, which will undergo three study visits

Intervention: Acute exercise bout on visit 2 and 3 (Other)

Outcomes

Primary Outcomes

Rest-to-exercise pulmonary DTPA clearance change after exercise in COPD vs. controls

Time Frame: Measured at study day 2

The physiological change from rest to exercise in DTPA clearance

Secondary Outcomes

  • Pulmonary DTPA clearance after exercise in COPD vs. controls(Measured at study day 2)
  • Pulmonary DTPA clearance at rest in COPD vs. controls(Measured at study day 2)
  • Rest-to-exercise change in lung tissue mass in COPD vs. controls(Measured at study day 2)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ronan Berg

MD, DMSc, Associate Professor

Rigshospitalet, Denmark

Study Sites (1)

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