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NCT Number: NCT07069959

Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation

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.

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Key information

Conditions

Intensive Care Unit Acquired Weakness Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire Atlantique, 44300, France

Location contact

Jean REIGNIER, UH Practitioner

CONTACT

[email protected]

+33240087365

Jean REIGNIER, UH Practitioner

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged > 18 years
  • Hospitalized in an ICU
  • Treated with invasive mechanical ventilation (MV) for at least 4 days during their stay (may be extubated at the time of inclusion)
  • Conscious and cooperative patients: ability to respond appropriately to the following commands: open and close eyes, look at me, nod your head, stick out your tongue, raise your eyebrows when I count to five
  • MRC score ≥ 3/5 for the "Leg Extension" function on either the left or right side
  • Informed consent obtained (no opposition)

Exclusion criteria

  • Pregnant or breastfeeding women
  • Fracture or amputation of a lower limb
  • Acute or chronic brain or spinal cord injury responsible for hemiplegia or paraplegia
  • Unstable spinal injury
  • Neurodegenerative or chronic neurological disease
  • Guillain-Barré Syndrome
  • Myasthenia Gravis
  • Acute deep vein thrombosis of the lower limbs treated within the last 48 hours
  • Pre-existing motor deficit in a lower limb before the ICU stay, of any cause
  • Incarcerated or legally protected individuals (guardianship, curatorship)
  • Individuals without social protection

Treatment and study plan

Early assessment of quadriceps muscle strength

Other

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.

Primary outcomes

  1. Describe the evolution of quadriceps muscle recovery using manual dynamometry in patients under invasive mechanical ventilation in the ICU.

    Time frame: 3 months

    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.

  2. Description of the evolution of the recovery of the rectus femoris muscle using 3D ultrasound in ICU patients treated with invasive mechanical ventilation.

    Time frame: 3 months after ICU discharge

    Change in the volume of the rectus femoris muscle measured by 3D ultrasound.

Secondary outcomes

  1. Estimate the average value of the FMQ

    Time frame: From inclusion to 3 months post-ICU discharge

    Measure the FMQ (Quadriceps Muscle Strength ) at multiple key time points to estimate recovery and muscle strength progression.

  2. To study the correlation between FMQ values and other muscular and functional scores on the same day.

    Time frame: From inclusion to 3 months post-ICU discharge

    Correlate FMQ with other muscular and functional scores

  3. Study the differences in muscle strength between right and left FMQ values on the same day

    Time frame: From inclusion to 3 months post-ICU discharge

    Compare right and left side FMQ measurements to assess potential asymmetries.

  4. Study the correlation between FMQ at inclusion and the time until extubation, when the patient was still intubated at inclusion

    Time frame: From inclusion to the day of extubation, an average of 7 days

    Investigate if FMQ at inclusion can predict extubation time in intubated patients.

  5. Study the correlation between FMQ at inclusion and the ability to achieve verticalization for patients who could stand before ICU discharge

    Time frame: From inclusion to ICU discharge, an average of 10 days

    Examine if FMQ at inclusion is predictive of the ability to achieve verticalization during the ICU stay.

  6. 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

    Time frame: From inclusion to ICU discharge, an average of 10 days

    Assess whether FMQ at inclusion predicts the ability to take first steps during the ICU stay.

  7. 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.

    Time frame: 3 months post-ICU discharge

    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.

  8. Examine how FMQ and VFMQ correlate with strength and functional measures at follow-up, and how physical activity impacts recovery.

    Time frame: 3 months post-ICU discharge

    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.

  9. Description of the recovery of the anterior tibial muscle using 3D ultrasound in ICU patients treated with invasive mechanical ventilation.

    Time frame: 3 months after ICU discharge

    Change in the volume of the anterior tibial muscle measured by 3D ultrasound.

  10. Correlation between changes in rectus femoris volume and functional recovery.

    Time frame: 3 months after ICU discharge

    Correlation between volume changes in rectus femoris muscle and functional recovery (between ICU discharge and 3 months post-ICU discharge).

  11. Correlation between changes in anterior tibial muscle volume and functional recovery.

    Time frame: 3 months after ICU discharge

    Correlation between volume changes in the anterior tibial muscle and functional recovery (between ICU discharge and 3 months post-ICU discharge).

  12. Correlation between changes in rectus femoris volume and muscle strength assessment tools.

    Time frame: 3 months after ICU discharge

  13. Correlation between changes in anterior tibial muscle volume and muscle strength assessment tools.

    Time frame: 3 months after ICU discharge

    Correlation between volume changes in the anterior tibial muscle and muscle strength.

  14. Link between rectus femoris volume and functional recovery.

    Time frame: at ICU discharge, an average of 10 days

    Link between rectus femoris volume and functional recovery (at ICU discharge)

  15. Link between rectus femoris volume and functional recovery.

    Time frame: 3 months after ICU discharge

    Link between rectus femoris volume and functional recovery (at 3 months post-ICU discharge)

  16. Link between anterior tibial muscle volume and functional recovery.

    Time frame: at ICU discharge, an average of 10 days

    Link between anterior tibial muscle volume and functional recovery (at ICU discharge)

  17. Link between anterior tibial muscle volume and functional recovery.

    Time frame: 3 months after ICU discharge

    Link between anterior tibial muscle volume and functional recovery (at ICU discharge)

Study contacts

Contact information is provided by the study sponsor or research team.

Jean REIGNIER, UH Practitioner

CONTACT

[email protected]

Research and Innovation Departement of Nantes UH

CONTACT

[email protected]

+33253482810

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation: A Monocentric and Prospective Study.

Acronym: DYNAMOREA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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