Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation

NCT06268171 | Completed

• 2 other identifiers: 2023_02142023-A02390-45
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

In France, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. This progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or COPD, and an increase in the average age of patients. In these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality. After transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. There is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. The combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the ICU. Muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. This study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. Objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity. In summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies.

Conditions

Lung Transplant; Physiotherapy; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation

  Baseline and Day 7

Secondary Outcomes (3)

• Measure change in cross-sectional area of the rectus femoris at D7 according to LT pattern

  Baseline and day 14

• Evaluate the relationship between length of stay in intensive care unit and variation in cross-sectional area of the rectus femoris at D7

  Baseline and day 7

• Determine the relationship between cross-sectional area of the rectus femoris at D-1 and Body Mass Index

  Baseline

Study Arms (1)

Study group

transplant patients with ultrasound measurement of the cross-sectional area of the rectus femoris

Other: ultrasound measurement of the cross-sectional area of the rectus femoris

Interventions

ultrasound measurement of the cross-sectional area of the rectus femoris OTHER

ultrasound measurement of the cross-sectional area of the rectus femoris at D-1 and D+3, +7 , +14

Study group

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

Lung transplant patients at Hôpital Foch

You may qualify if:

• Patient over the age of 18
• Patient registered on the lung transplant list at Hôpital Foch for a single or double-lung transplant
• Patient affiliated to a French health insurance plan

You may not qualify if:

• Patient listed for a combined transplant (heart-lung, liver-lung, lung-kidney)
• Patient on national priority list (super-emergency)
• Pregnant or breast-feeding patient
• Patient under guardianship

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, Hauts de seine, 92151, France

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Matthieu Reffienna

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 61 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: March 27, 2024
• Primary Completion: April 4, 2025
• Study Completion: May 27, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

FR (1)