NCT06287476

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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

February 12, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
Last Updated

December 8, 2025

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

February 12, 2024

Last Update Submit

December 1, 2025

Conditions

Keywords

COPDAlveolar-capillary membrane integrityLung tissue massCardiac OutputDLCO/DLNO

Outcome Measures

Primary Outcomes (1)

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

    The physiological change from rest to exercise in DTPA clearance

    Measured at study day 2

Secondary Outcomes (3)

  • Pulmonary DTPA clearance at rest in COPD vs. controls

    Measured at study day 2

  • Pulmonary DTPA clearance after exercise 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

Other Outcomes (13)

  • Lung tissue mass at rest in COPD vs. controls

    Measured at study day 2

  • Lung tissue mass after exercise in COPD vs. controls

    Measured at study day 2

  • Rest-to-exercise pulmonary DTPA clearance and lung tissue mass change according to GOLD

    Measured at study day 2

  • +10 more other outcomes

Study Arms (2)

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

Other: Acute exercise bout on visit 2 and 3

COPD group

EXPERIMENTAL

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

Other: Acute exercise bout on visit 2 and 3

Interventions

1\) a 5-minute warm-up, 2) 4 minutes at 60% of the maximal workload (determined on Study Day 1), 3) 2 minutes active break at 15 watt, 4) 4 minutes at maximal workload.

COPD groupControl Group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women
  • years old
  • COPD (GOLD stage I to III)
  • Resting arterial oxygenation \> 90%
  • Men and women
  • years old
  • Non-smokers
  • Normal lung function
  • Same sex, age (± 3 years) as the COPD group

You may not qualify if:

  • 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)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center For Physical Activity Research, Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc, Associate Professor

Study Record Dates

First Submitted

February 12, 2024

First Posted

March 1, 2024

Study Start

May 6, 2024

Primary Completion

May 2, 2025

Study Completion

May 2, 2025

Last Updated

December 8, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations