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NCT Number: NCT06135701

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

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.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, København Ø, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

for healthy matched controls:

  • Known chronic lung disease
  • Known ischaemic heart disease
  • Known heart failure
  • Symptoms of disease within 2 weeks prior to the study
  • Known malignant disease
  • Claudication
  • Pregnancy
  • Unstable cardiac arrhythmic disease
  • Renal or liver dysfunction

Treatment and study plan

One-legged knee-extensor exercise with Doppler measurements

Diagnostic Test

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

Primary outcomes

  1. Between-day smallest real difference (SRD) for femoral blood flow at rest and at each relative exercise intensity in COPD vs. healthy controls

    Time frame: Measured at day 1 and day 2

    Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.

  2. • 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)

    Time frame: Measured at day 1 and day 2

    Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.

Secondary outcomes

  1. Femoral blood flow response to exercise at each relative exercise intensity in COPD vs. healthy controls (key secondary)

    Time frame: Measured at day 1 and day 2

    Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.

  2. Between-day smallest real difference (SRD) for femoral blood flow at rest and at each absolute exercise intensity in COPD vs. healthy controls

    Time frame: Measured at day 1 and day 2

    Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.

  3. • 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)

    Time frame: Measured at day 1 and day 2

    Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: COPD-DOPPLER

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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