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

NCT ID: NCT06135701

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-21
• Study Completion Date: 2024-01-12

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.

Conditions

COPD; Healthy; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

COPD-patients

The participants will be instructed to abstain from caffeine, nicotine, alcohol, and strenuous exercise all known to affect blood flow to the limb for 12 hours prior to the study day. After being placed on the one-leg kicking chair, baseline measurements will be performed, followed by passive leg movement for 2 minutes. Then participants will perform one-legged knee-extension exercise at submaximal intensity, first at 10% and then at 20% of the previously measured WLpeak, remaining 3.5 minutes at each level, while femoral blood flow is measured. This study day will be repeated within 2-10 days.

Group Type: EXPERIMENTAL

One-legged knee-extensor exercise with Doppler measurements

Intervention Type: DIAGNOSTIC_TEST

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

Matched healthy volunteers

The participants will be instructed to abstain from caffeine, nicotine, alcohol, and strenuous exercise all known to affect blood flow to the limb for 12 hours prior to the study day. After being placed on the one-leg kicking chair, baseline measurements will be performed, followed by passive leg movement for 2 minutes. Then participants will perform one-legged knee-extension exercise at submaximal intensity, first at 10% and then at 20% of the previously measured WLpeak, remaining 3.5 minutes at each level, while femoral blood flow is measured. This study day will be repeated within 2-10 days.

Group Type: EXPERIMENTAL

One-legged knee-extensor exercise with Doppler measurements

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

One-legged knee-extensor exercise with Doppler measurements

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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%

• 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

• 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

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Milan Mohammad

BSc(Med) and principal investigator at Center for Aktiv Sundhed (CFAS), Rigshospitalet.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Copenhagen, København Ø, Denmark

Countries

Denmark

Other Identifiers

H-23049997

Identifier Type: -

Identifier Source: org_study_id