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

Recruiting

• Conditions: COPD; Quadriceps Muscle Atrophy

• Registration Number: NCT06994689
• Lead Sponsor: Groupe Hospitalier du Havre

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.

Study Timeline

• Study First Submitted: 2025-03-27
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Study Start: 2025-05-30
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perimetry of the quadriceps	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	At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)	ShearWave elastography of the quadriceps muscle

Secondary Outcome Measures

Name	Time	Method
Functional exercise capacity	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
Health-Related Quality of Life	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))
Quadriceps thickness	At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)	measured by ultrasonography
Quadriceps strength	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
Lean body mass	At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)	measured by bioelectrical impedance

Trial Locations

Locations (1)

Groupe Hospitalier du Havre; 🇫🇷 Le Havre, France