COPDCOPD-DOPPLERNCT06135701
Femoral Artery Blood Flow During Rest and One-leg Knee Extensor Exercise in Patients With COPD
A study testing One-legged knee-extensor exercise with Doppler measurements in people with COPD and Healthy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD, Healthy, Chronic Obstructive Pulmonary Disease
- What is being tested?
- One-legged knee-extensor exercise with Doppler measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Nov 2023to 12 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 45-80 years
- Normal FEV1, FVC, FEV1/FVC, and single-breath diffusion capacity
- Same sex, age (± 3 years) as the COPD patients
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Aktiv Sundhed (CFAS), Rigshospitalet, Copenhagen, Denmark.
Copenhagen, København Ø, 2100
About this study
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.
Read the 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
- Being tested
- One-legged knee-extensor exercise with Doppler measurements
- Keywords
- Ultrasound, COPD, Test-retest
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-legged knee-extensor exercise with Doppler measurementsDiagnostic test
Doppler ultrasound is used while participants exercise according to the one-legged knee-extensor exercise model
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: One-legged knee-extensor exercise with Doppler measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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)
Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.
Measured: 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
Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.
Measured: 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)
Doppler ultrasound measured blood flow during one leg knee extensor exercise with different intensities.
Measured: Measured at day 1 and day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start21 Nov 2023
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 ̅).
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milan Mohammad, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135701
- Sponsor's protocol ID
- H-23049997
- Acronym
- COPD-DOPPLER
- Status last verified
- Jan 2024
- First submitted
- 12 Nov 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Can be retrieved upon request from primary investigator.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Artery Blood Flow During Rest and One-leg Knee Extensor Exercise in Patients With COPD
- ClinicalTrials.gov ID
- NCT06135701
- Acronym / sponsor ID
- COPD-DOPPLER / H-23049997
- Conditions
- COPD, Healthy, Chronic Obstructive Pulmonary Disease
- Keywords
- Ultrasound, COPD, Test-retest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 ̅).
| Arm | Type | Receives |
|---|---|---|
| COPD-patients | Experimental | Diagnostic Test: One-legged knee-extensor exercise with Doppler measurementsThe 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. |
| Matched healthy volunteers | Experimental | Diagnostic Test: One-legged knee-extensor exercise with Doppler measurementsThe 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-legged knee-extensor exercise with Doppler measurementsDoppler ultrasound is used while participants exercise according to the one-legged knee-extensor exercise model | Diagnostic test | COPD-patients, Matched healthy volunteers |
Primary outcome
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.
• 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.
3 secondary outcomes
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
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
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: Undecided. Can be retrieved upon request from primary investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-legged knee-extensor exercise with Doppler measurements in people with COPD and Healthy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.