Clinical trial NCT06994689: Clinimetric Properties of Muscle Mass and Stiffness Measurements of the Quadriceps in Patients With COPD
Official title: Clinimetric Properties Assessment of Quadriceps Muscle Mass and Stiffness Using Perimetry and ShearWave Elastography in Patients With COPD : a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Quadriceps Muscle Atrophy
Keywords: Clinimetric properties
Muscle mass
Muscle strength
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients completing a PR programme for 5 weeks

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perimetry of the quadriceps
timeFrame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
measure: Quadriceps stiffness
timeFrame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Secondary outcomes:
measure: Lean body mass
timeFrame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
measure: Functional exercise capacity
timeFrame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
measure: Health-Related Quality of Life
timeFrame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
measure: Quadriceps thickness
timeFrame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
measure: Quadriceps strength
timeFrame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)
Other outcomes:
Locations:
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre
Study officials:
References: