Alveolar-capillary Reserve After Exercise in Chronic Obstructive Pulmonary Disease (COPD) (COP-DTPA)
1 other identifier
interventional
32
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2024
CompletedFirst Posted
Study publicly available on registry
March 1, 2024
CompletedStudy Start
First participant enrolled
May 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2025
CompletedDecember 8, 2025
February 1, 2024
12 months
February 12, 2024
December 1, 2025
Conditions
Keywords
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
EXPERIMENTALThis arm consist of only healthy participants (age (+/- 3 years) and sex matched to the COPD group), which will undergo three study visits
COPD group
EXPERIMENTALThis arm consist of only COPD patients, which will undergo three study visits
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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