Clinimetric Properties of Muscle Mass and Stiffness Measurements of the Quadriceps in Patients With COPD
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perimetry and ShearWave measurement of the quadriceps muscle before and after a pulmonary rehabilitation (PR) programme.
- Who it may be relevant to
- Registry conditions: COPD, Quadriceps Muscle Atrophy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinimetric Properties Assessment of Quadriceps Muscle Mass and Stiffness Using Perimetry and ShearWave Elastography in Patients With COPD : a Prospective Observational Study
Overview
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.
Interventions
- Diagnostic test Perimetry and ShearWave measurement of the quadriceps muscle before and after a pulmonary rehabilitation (PR) programme
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.
Primary outcome measures
- Perimetry of the quadriceps [Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)]
- Quadriceps stiffness [Time frame: At day 1 and after 5 weeks (at the end of the 5 weeks pulmonary rehabilitation program)]
Secondary outcome measures (5)
- 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Groupe Hospitalier du Havre — Le Havre
Identifiers
NCT: NCT06994689 · 2022-A00297-36