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NCT Number: NCT06994689

Clinimetric Properties of Muscle Mass and Stiffness Measurements of the Quadriceps in Patients With COPD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier du Havre

Le Havre, 76290, France

Location status: Recruiting

Location contact

Claire Dubois, PT

CONTACT

[email protected]

(+33)630039745

Claire Dubois, PT

PRINCIPAL_INVESTIGATOR

Yann Combret, PhD

CONTACT

[email protected]

(+33)686327255

Yann Combret, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COPD patients
  • Adults (>18 years old)
  • Patients starting a pulmonary rehabilitation (PR) programme

Exclusion criteria

  • 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

Treatment and study plan

Perimetry and ShearWave measurement of the quadriceps muscle before and after a pulmonary rehabilitation (PR) programme

Diagnostic Test

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.

Other names: Functional exercice capacity, Quality of life, Bioelectrical impedance, Quadriceps thickness, Quadriceps strength : maximal voluntary contraction

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Lean body mass

    Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)

    measured by bioelectrical impedance

  2. Functional exercise capacity

    Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)

    measured as the endurance time during a constant load endurance test using a cycloergometer or a treadmill

  3. Health-Related Quality of Life

    Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)

    measured by quality of life questionnaire (hospital anxiety and depression scale (HAD))

  4. Quadriceps thickness

    Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)

    measured by ultrasonography

  5. Quadriceps strength

    Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)

    measure of maximal voluntary contraction with handheld dynamometry

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Dubois, PT

CONTACT

[email protected]

(+33)630039745

Yann Combret, PhD

CONTACT

[email protected]

(+33)686327255

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier du Havre

Other

Registry information

Official study title

Clinimetric Properties Assessment of Quadriceps Muscle Mass and Stiffness Using Perimetry and ShearWave Elastography in Patients With COPD : a Prospective Observational Study

Acronym: Metriquad

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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