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

NCT06135701 | Completed

• 1 other identifier: H-23049997
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Healthy; Chronic Obstructive Pulmonary Disease

Keywords

Ultrasound; COPD; Test-retest

Outcome Measures

Primary Outcomes (2)

• 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

• • 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 Outcomes (3)

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

  Measured at day 1 and day 2

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

  Measured at day 1 and day 2

• • 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 2

Study Arms (2)

COPD-patients

EXPERIMENTAL

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.

Diagnostic Test: One-legged knee-extensor exercise with Doppler measurements

Matched healthy volunteers

EXPERIMENTAL

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.

Diagnostic Test: One-legged knee-extensor exercise with Doppler measurements

Interventions

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

COPD-patients; Matched healthy volunteers

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• 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%

You may not qualify if:

• 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
• Men and women
• years
• Normal FEV1, FVC, FEV1/FVC, and single-breath diffusion capacity
• Same sex, age (± 3 years) as the COPD patients
• Known chronic lung disease
• Known ischaemic heart disease

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

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

Copenhagen, København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc(Med) and principal investigator at Center for Aktiv Sundhed (CFAS), Rigshospitalet.

Model Details: 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 ̅).

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: November 21, 2023
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

DK (1)