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

Healthy Clinical Trial

— COPD-DOPPLER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06135701
• Other study ID #: H-23049997
• Status: Completed
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: January 12, 2024

Study information

• Verified date: January 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Healthy
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• One-legged knee-extensor exercise with Doppler measurements
Doppler ultrasound is used while participants exercise according to the one-legged knee-extensor exercise model

Locations

Country	Name	City	State
Denmark	Center for Aktiv Sundhed (CFAS), Rigshospitalet, Copenhagen, Denmark.	Copenhagen	København Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between-day smallest real difference (SRD) for femoral blood flow at rest and at each relative exercise intensity in COPD vs. healthy controls	Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.	Measured at day 1 and day 2
Primary	• 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)	Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.	Measured at day 1 and day 2
Secondary	Femoral blood flow response to exercise at each relative exercise intensity in COPD vs. healthy controls (key secondary)	Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.	Measured at day 1 and day 2
Secondary	Between-day smallest real difference (SRD) for femoral blood flow at rest and at each absolute exercise intensity in COPD vs. healthy controls	Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.	Measured at day 1 and day 2
Secondary	• 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)	Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.	Measured at day 1 and day 2