COPDMetriquadNCT06994689
Clinimetric Properties of Muscle Mass and Stiffness Measurements of the Quadriceps in Patients With COPD
An observational study of COPD and Quadriceps Muscle Atrophy, run by Groupe Hospitalier du Havre at 1 site in France.
Trial summary
A large amount of patients with COPD suffer from muscle dysfunction characterized by losses of muscle mass and strength. Studies have shown an association between a loss of quadriceps muscle mass and premature death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Quadriceps Muscle Atrophy
- What is being tested?
- Perimetry and ShearWave measurement of the quadriceps muscle before and after a pulmonary rehabilitation (PR) programme
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients completing a PR programme for 5 weeks
Who may be able to join
- COPD patients
- Adults (>18 years old)
- Patients starting a pulmonary rehabilitation (PR) programme
Who cannot join
- Patients included in other research protocol
- Minors or under guardianship
- Pregnancy
- Patients with lower limb amputation or history of neuromuscular disease
- Cardiovascular contradications for PR
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier du Havre
Le Havre, 76290
Claire Dubois, PT, (+33)630039745, claire.dubois@ch-havre.fr
Yann Combret, PhD, (+33)686327255, yann.combret@ch-havre.fr
About this study
Official title: Clinimetric Properties Assessment of Quadriceps Muscle Mass and Stiffness Using Perimetry and ShearWave Elastography in Patients With COPD : a Prospective Observational Study
A large amount of patients with COPD suffer from muscle dysfunction characterized by losses of muscle mass and strength. Studies have shown an association between a loss of quadriceps muscle mass and premature death.
This study aims to investigate the clinimetric properties of a simple quadriceps perimetry and ShearWave elastography to improve the monitoring of skeletal muscle function in patients with COPD.
Read the detailed description
Muscle dysfunction in COPD is characterized by reduced skeletal muscle mass and strength, particularly in the lower limbs. These systemic consequences of COPD play a key role in the course of these patients, through their impact on functional status, quality of life and increased mortality. Early detection and monitoring of muscular status in these patients could help improve management and limit the consequences of the disease.
Numerous studies show that variation in quadriceps mass has a significant relationship with premature mortality in this disease. The use of an indirect but simple and affordable measure: perimetric tape-measurement of thigh circumference, could help monitor quadriceps muscle mass in these patients on a regular and cost-effective basis. However, the clinimetric properties (validity, reliability, response to treatment) of this measurement need to be assessed to clarify its relevance.
On the other hand, ShearWave ® elastography (SWE) is a new method of measuring quadriceps stiffness. This measurement could provide additional information on muscle quality compared with conventional measures of strength or muscle trophicity. The potential added value of SWE ® for COPD patients has not yet been investigated. This tool would provide more precise indications of the state of the quadriceps, with the aim of improving the management of this pathology.
- Conditions
- COPD, Quadriceps Muscle Atrophy
- Being tested
- Perimetry and ShearWave measurement of the quadriceps muscle before and after a pulmonary rehabilitation (PR) programme
- Keywords
- Clinimetric properties, Muscle mass, Muscle strength
- 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.
Perimetry and ShearWave measurement of the quadriceps muscle before and after a pulmonary rehabilitation (PR) programmeDiagnostic test
Also called Functional exercice capacity, Quality of life, Bioelectrical impedance, Quadriceps thickness
Patients will undergo a pulmonary rehabilitation (PR) programme.
On day 1, perimetry and ShearWave measurements of the quadriceps muscle will be provided. Supplementary assessments of quadriceps thickness, quadriceps strength with a handheld dynamometry, lean body mass (bioelectrical impedance), constant work-rate endurance test and HAD questionnaire will also be provided on day 1.
The same measurements and questionnaire will be provided on the last day of the patient in the PR programme.
What is being measured
The primary outcome is the main question the study is designed to answer.
Perimetry of the quadriceps
Thigh circumference measured by a tape
Measured: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Quadriceps stiffness
ShearWave elastography of the quadriceps muscle
Measured: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Secondary outcomes (5)
Lean body mass
measured by bioelectrical impedance
Measured: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Functional exercise capacity
measured as the endurance time during a constant load endurance test using a cycloergometer or a treadmill
Measured: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Health-Related Quality of Life
measured by quality of life questionnaire (hospital anxiety and depression scale (HAD))
Measured: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Quadriceps thickness
measured by ultrasonography
Measured: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Quadriceps strength
measure of maximal voluntary contraction with handheld dynamometry
Measured: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start30 May 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994689
- Sponsor's protocol ID
- 2022-A00297-36
- Acronym
- Metriquad
- Status last verified
- Jan 2026
- First submitted
- 27 Mar 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinimetric Properties Assessment of Quadriceps Muscle Mass and Stiffness Using Perimetry and ShearWave Elastography in Patients With COPD : a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06994689
- Acronym / sponsor ID
- Metriquad / 2022-A00297-36
- Conditions
- COPD, Quadriceps Muscle Atrophy
- Keywords
- Clinimetric properties, Muscle mass, Muscle strength
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 May 2025 (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.
A large amount of patients with COPD suffer from muscle dysfunction characterized by losses of muscle mass and strength. Studies have shown an association between a loss of quadriceps muscle mass and premature death.
This study aims to investigate the clinimetric properties of a simple quadriceps perimetry and ShearWave elastography to improve the monitoring of skeletal muscle function in patients with COPD.
Detailed description
Muscle dysfunction in COPD is characterized by reduced skeletal muscle mass and strength, particularly in the lower limbs. These systemic consequences of COPD play a key role in the course of these patients, through their impact on functional status, quality of life and increased mortality. Early detection and monitoring of muscular status in these patients could help improve management and limit the consequences of the disease.
Numerous studies show that variation in quadriceps mass has a significant relationship with premature mortality in this disease. The use of an indirect but simple and affordable measure: perimetric tape-measurement of thigh circumference, could help monitor quadriceps muscle mass in these patients on a regular and cost-effective basis. However, the clinimetric properties (validity, reliability, response to treatment) of this measurement need to be assessed to clarify its relevance.
On the other hand, ShearWave ® elastography (SWE) is a new method of measuring quadriceps stiffness. This measurement could provide additional information on muscle quality compared with conventional measures of strength or muscle trophicity. The potential added value of SWE ® for COPD patients has not yet been investigated. This tool would provide more precise indications of the state of the quadriceps, with the aim of improving the management of this pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients completing a PR programme for 5 weeks
Key inclusion criteria (3 listed)
- COPD patients
- Adults (>18 years old)
- Patients starting a pulmonary rehabilitation (PR) programme
Key exclusion criteria (5 listed)
- Patients included in other research protocol
- Minors or under guardianship
- Pregnancy
- Patients with lower limb amputation or history of neuromuscular disease
- Cardiovascular contradications for PR
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 |
|---|---|---|
| Perimetry and ShearWave measurement of the quadriceps muscle before and after a pulmonary rehabilitation (PR) programmeAlso: Functional exercice capacity, Quality of life, Bioelectrical impedance, Quadriceps thicknessPatients will undergo a pulmonary rehabilitation (PR) programme. On day 1, perimetry and ShearWave measurements of the quadriceps muscle will be provided. Supplementary assessments of quadriceps thickness, quadriceps strength with a handheld dynamometry, lean body mass (bioelectrical impedance), constant work-rate endurance test and HAD questionnaire will also be provided on day 1. The same measurements and questionnaire will be provided on the last day of the patient in the PR programme. | Diagnostic test | – |
Primary outcome
Perimetry of the quadriceps
Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Thigh circumference measured by a tape
Quadriceps stiffness
Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
ShearWave elastography of the quadriceps muscle
5 secondary outcomes
Lean body mass
Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Functional exercise capacity
Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Health-Related Quality of Life
Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Quadriceps thickness
Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Quadriceps strength
Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Quadriceps Muscle Atrophy, run by Groupe Hospitalier du Havre at 1 site in France.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Dubois, PT ((+33)630039745, claire.dubois@ch-havre.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perimetry of the quadriceps (time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)). 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 21 Jan 2026.