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Femoral Artery Blood Flow During Rest and One-leg Knee Extensor Exercise in Patients With COPD

Femoral Artery Blood Flow During Rest and One-leg Knee Extensor Exercise in Patients With COPD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06135701
Acronym
COPD-DOPPLER
Enrollment
32
Registered
2023-11-18
Start date
2023-11-21
Completion date
2024-01-12
Last updated
2024-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, COPD, Healthy

Keywords

Ultrasound, COPD, Test-retest

Brief summary

Doppler ultrasound is generally considered to provide reliable femoral blood flow measurements between rest and exercise, and the blood flow response to exercise is widely believed to be reduced in patients with chronic obstructive pulmonary disease (COPD). However, the test-retest reliability of the method during one-leg knee extensor exercise has not previously been compared between matched healthy individuals.

Detailed description

Experimental assessments of changes in skeletal muscle blood flow during exercise in humans are important for elucidating the factors that limit exercise capacity and adaptations, both in healthy humans, including athletes, as well as in various disease states with functional impairment, such as chronic obstructive pulmonary disease COPD). A classical 'gold standard' for measuring blood flow is thermodilution, and this has notably applied to provide data on femoral blood flow during exercise. Because thermodilution required invasive catheterization, many have replaced it with Doppler ultrasound, but the test-retest reliability of Doppler ultrasound in this context is unknown. However, many studies have used Doppler ultrasound to document that the femoral blood flow response to exercise is impaired in COPD, which ultimately affects oxygen uptake and thus exercise capacity, but the interpretation of these findings is currently hampered by the lack of knowledge regarding the test-retest reliability of the method in this patient group. The investigators aim is to compare the femoral blood flow response to one-legged knee extensor exercise in patients with COPD vs. healthy participants, and to provide an estimate of the test-retest reliability the femoral blood flow measurements obtained by Doppler ultrasound.

Interventions

DIAGNOSTIC_TESTOne-legged knee-extensor exercise with Doppler measurements

Doppler ultrasound is used while participants exercise according to the one-legged knee-extensor exercise model

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Experimental setup Femoral blood flow will be measured by Doppler ultrasound at rest and during one-knee leg extensor exercise. Preliminary maximal knee extensor test The maximal workload (WLpeak) of the thigh muscles during one-legged knee-extensor exercise on a customized one-leg kicking chair will be determined. One-legged knee-extensor exercise protocol In rest upright and supine 0 watt 20%watt max 10 watt. This study day will be repeated within 2-7 days. Doppler ultrasound Doppler-based blood flow in the common femoral artery (QDop) is obtained using a linear probe (4.3-5.0 MHz) to obtain two-dimensional (2D) femoral arterial cross-sectional area (A) and mean blood velocity (v ̅).

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

for COPD patients: * Men and women * 45-80 years * COPD (GOLD stage I to III) * Forced expiratory volume in 1 sec (FEV1)/forced vital capacity ratio (FVC) \< 0.8, FEV1 \< 90% of predicted value * Modified Medical Research Council score (mMRC 0 - 3) Resting arterial oxygenation \> 90%

Exclusion criteria

for COPD patients: * Symptoms of ischaemic heart disease * Known heart failure * Claudication * Symptoms of disease within 2 weeks prior to the study * Participation in pulmonary rehabilitation within 6 months * Known malignant disease * Pregnancy * Unstable cardiac arrhythmic disease * Renal or liver dysfunction Inclusion Criteria for healthy matched controls: * Men and women * 45-80 years * Normal FEV1, FVC, FEV1/FVC, and single-breath diffusion capacity * Same sex, age (± 3 years) as the COPD patients

Design outcomes

Primary

MeasureTime frameDescription
Between-day smallest real difference (SRD) for femoral blood flow at rest and at each relative exercise intensity in COPD vs. healthy controlsMeasured at day 1 and day 2Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.
• Between-day coefficient of variance (CV) for femoral blood flow at rest and at each relative exercise intensity in COPD vs. healthy controls (co-primary)Measured at day 1 and day 2Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.

Secondary

MeasureTime frameDescription
Femoral blood flow response to exercise at each relative exercise intensity in COPD vs. healthy controls (key secondary)Measured at day 1 and day 2Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.
Between-day smallest real difference (SRD) for femoral blood flow at rest and at each absolute exercise intensity in COPD vs. healthy controlsMeasured at day 1 and day 2Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.
• Between-day coefficient of variance (CV) for femoral blood flow at rest and at each absolute exercise intensity in COPD vs. healthy controls (co-primary)Measured at day 1 and day 2Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026