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

NCT06994689 | Recruiting

• 1 other identifier: 2022-A00297-36
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Quadriceps Muscle Atrophy

Keywords

Clinimetric properties; Muscle mass; Muscle strength

Outcome Measures

Primary Outcomes (2)

• Perimetry of the quadriceps

  Thigh circumference measured by a tape

  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

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

Secondary Outcomes (5)

• Lean body mass

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

• Functional exercise capacity

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

• Health-Related Quality of Life

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

• Quadriceps thickness

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

• Quadriceps strength

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

Interventions

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.

Also known as: Functional exercice capacity, Quality of life, Bioelectrical impedance, Quadriceps thickness, Quadriceps strength : maximal voluntary contraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients completing a PR programme for 5 weeks

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier du Havre: lead

Study Sites (1)

Groupe Hospitalier du Havre

Le Havre, 76290, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Visual Field Tests; Electric Impedance

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electric Conductivity; Electricity; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena

Central Study Contacts

Claire Dubois, PT

CONTACT

(+33)630039745; claire.dubois@ch-havre.fr

Yann Combret, PhD

CONTACT

(+33)686327255; yann.combret@ch-havre.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: May 29, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning after publication and ending 60 months following article publication.
• Access Criteria: For individual participant data meta-analysis. Proposals should be directed to yann.combret@gmail.com. To gain access, data requestors will need to sign a data access agreement.

Locations

FR (1)