An observational study in Intensive Care Unit Acquired Weakness and Muscle Weakness, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Nantes University Hospital · Observational
Patients in intensive care often develop acquired muscle weakness (ICUAW or Intensive Care Unit Acquired Weakness) due to immobilization and muscle atrophy. Early mobilization can help reduce weakness and improve functional recovery, but practices vary. Muscle strength assessment, particularly using the MRC (Medical Research Council) score, is crucial, though it has precision limitations. Additional methods, such as manual dynamometry and functional scales, are needed to better track muscle recovery. The quadriceps, important for function, requires early evaluation, but there is a lack of specific data in intensive care to predict medium-term functional recovery.
477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.
This study's planned enrollment of 100 is above the median of 68 across 108 observational studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
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The study population includes adults (aged >18 years) admitted to the ICU and treated with invasive mechanical ventilation for at least 4 days. Participants must be conscious, cooperative, and have an MRC score ≥ 3/5 for "Leg Extension" on either side. Informed consent or no objection is required. Exclusion criteria include pregnancy, neurological disorders, lower limb injuries, or conditions preventing safe participation.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group includes patients admitted to the Intensive Care Unit (ICU) at the CHU of Nantes, treated with invasive mechanical ventilation. The study aims to evaluate the early recovery of quadriceps muscle strength in these patients, using non-invasive, pain-free assessment methods. The cohort will consist of approximately 100 patients over one year, with data collected via the medical record and strength measurements performed by physical therapists.
Other: Early assessment of quadriceps muscle strength
Patients will undergo non-invasive assessment of quadriceps muscle strength using manual dynamometry and 3D ultrasound. These assessments will be conducted regularly during their ICU stay to evaluate early recovery. The intervention is part of routine patient care and does not involve additional treatments or procedures.
Describe the evolution of quadriceps muscle recovery using manual dynamometry in patients under invasive mechanical ventilation in the ICU.
This study aims to describe the evolution of quadriceps muscle recovery in ICU patients under invasive mechanical ventilation, using manual dynamometry as a measurement tool. The recovery will be assessed periodically throughout the ICU stay to evaluate early muscle strength recovery.
Time frame: 3 months
Description of the evolution of the recovery of the rectus femoris muscle using 3D ultrasound in ICU patients treated with invasive mechanical ventilation.
Change in the volume of the rectus femoris muscle measured by 3D ultrasound.
Time frame: 3 months after ICU discharge
Estimate the average value of the FMQ
Measure the FMQ (Quadriceps Muscle Strength ) at multiple key time points to estimate recovery and muscle strength progression.
Time frame: From inclusion to 3 months post-ICU discharge
To study the correlation between FMQ values and other muscular and functional scores on the same day.
Correlate FMQ with other muscular and functional scores
Time frame: From inclusion to 3 months post-ICU discharge
Study the differences in muscle strength between right and left FMQ values on the same day
Compare right and left side FMQ measurements to assess potential asymmetries.
Time frame: From inclusion to 3 months post-ICU discharge
Study the correlation between FMQ at inclusion and the time until extubation, when the patient was still intubated at inclusion
Investigate if FMQ at inclusion can predict extubation time in intubated patients.
Time frame: From inclusion to the day of extubation, an average of 7 days
Study the correlation between FMQ at inclusion and the ability to achieve verticalization for patients who could stand before ICU discharge
Examine if FMQ at inclusion is predictive of the ability to achieve verticalization during the ICU stay.
Time frame: From inclusion to ICU discharge, an average of 10 days
Study the correlation between FMQ at inclusion and the ability to take the first steps for patients who were able to walk before ICU discharge
Assess whether FMQ at inclusion predicts the ability to take first steps during the ICU stay.
Time frame: From inclusion to ICU discharge, an average of 10 days
Search for an association (survival model) between FMQ (Nm/kg) measured on the day of inclusion and the time (in days) between inclusion and the first steps taken successfully.
Study the presence of a link between FMQ (obtained on the day when the patient discharge criteria) and VFMQ (obtained between the day of inclusion and the day the patient inclusion and the day on which the patient meets the criteria for discharge from intensive care) and the patient's functional capacity at the 3-month post-resuscitation consultation. post-resuscitation, linked to an assessment of physical activity during this period. carried out during this period.
Time frame: 3 months post-ICU discharge
Examine how FMQ and VFMQ correlate with strength and functional measures at follow-up, and how physical activity impacts recovery.
To study the presence of a link between FMQ (obtained on the day the patient meets the criteria for discharge from intensive care) / VFMQ (obtained between the day of inclusion and the day the patient meets the criteria for discharge from intensive care) and the strength measurement scores obtained during the consultation 3 months after discharge from intensive care, linked to an assessment of physical activity carried out during this period. during this period.
Time frame: 3 months post-ICU discharge
Description of the recovery of the anterior tibial muscle using 3D ultrasound in ICU patients treated with invasive mechanical ventilation.
Change in the volume of the anterior tibial muscle measured by 3D ultrasound.
Time frame: 3 months after ICU discharge
Correlation between changes in rectus femoris volume and functional recovery.
Correlation between volume changes in rectus femoris muscle and functional recovery (between ICU discharge and 3 months post-ICU discharge).
Time frame: 3 months after ICU discharge
Correlation between changes in anterior tibial muscle volume and functional recovery.
Correlation between volume changes in the anterior tibial muscle and functional recovery (between ICU discharge and 3 months post-ICU discharge).
Time frame: 3 months after ICU discharge
Correlation between changes in rectus femoris volume and muscle strength assessment tools.
Time frame: 3 months after ICU discharge
Correlation between changes in anterior tibial muscle volume and muscle strength assessment tools.
Correlation between volume changes in the anterior tibial muscle and muscle strength.
Time frame: 3 months after ICU discharge
Link between rectus femoris volume and functional recovery.
Link between rectus femoris volume and functional recovery (at ICU discharge)
Time frame: at ICU discharge, an average of 10 days
Link between rectus femoris volume and functional recovery.
Link between rectus femoris volume and functional recovery (at 3 months post-ICU discharge)
Time frame: 3 months after ICU discharge
Link between anterior tibial muscle volume and functional recovery.
Link between anterior tibial muscle volume and functional recovery (at ICU discharge)
Time frame: at ICU discharge, an average of 10 days
Link between anterior tibial muscle volume and functional recovery.
Link between anterior tibial muscle volume and functional recovery (at ICU discharge)
Time frame: 3 months after ICU discharge
Plan to share: Undecided
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