Intensive Care Unit Acquired WeaknessDYNAMOREANCT07069959
Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation
An observational study of Intensive Care Unit Acquired Weakness and Muscle Weakness, run by Nantes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Acquired Weakness, Muscle Weakness
- What is being tested?
- Early assessment of quadriceps muscle strength
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2025to 3 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jean REIGNIER, UH Practitioner contact
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, Loire Atlantique, 44300
Jean REIGNIER, UH Practitioner, +33240087365, jean.reignier@chu-nantes.fr
Jean REIGNIER, UH Practitioner
About this study
Official 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.
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.
- Being tested
- Early assessment of quadriceps muscle strength
- Keywords
- dynamometry, muscle weakness, intensive care, functional recovery, invasive mechanical ventilation, 3D ultrasound
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early assessment of quadriceps muscle strengthOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients under invasive mechanical ventilation in the ICU | 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. Receives: Other: Early assessment of quadriceps muscle strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months after ICU discharge
Secondary outcomes (17)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 3 months after ICU discharge
Correlation between changes in rectus femoris volume and muscle strength assessment tools.
Measured: 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.
Measured: 3 months after ICU discharge
Link between rectus femoris volume and functional recovery.
Link between rectus femoris volume and functional recovery (at ICU discharge)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start3 Oct 2025
- Primary completion3 Jan 2028 (estimated)
- Study completion3 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit Acquired WeaknessStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069959
- Sponsor's protocol ID
- RC25_0138
- Acronym
- DYNAMOREA
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07069959
- Acronym / sponsor ID
- DYNAMOREA / RC25_0138
- Keywords
- dynamometry, muscle weakness, intensive care, functional recovery, invasive mechanical ventilation, 3D ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 3 Jan 2028 (estimated)
- Study completion
- 3 Jan 2028 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients under invasive mechanical ventilation in the ICU | – | Other: Early assessment of quadriceps muscle strengthThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early assessment of quadriceps muscle strengthPatients 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. | Other | Patients under invasive mechanical ventilation in the ICU |
Primary outcome
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.
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.
17 secondary outcomes
Estimate the average value of the FMQ
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.
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
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
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
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
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.
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.
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.
Time frame: 3 months after ICU discharge
Correlation between changes in rectus femoris volume and functional recovery.
Time frame: 3 months after ICU discharge
Correlation between changes in anterior tibial muscle volume and functional recovery.
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.
Time frame: 3 months after ICU discharge
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.
Time frame: 3 months after ICU discharge
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.
Time frame: 3 months after ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean REIGNIER, UH Practitioner contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Acquired Weakness and Muscle Weakness, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research and Innovation Departement of Nantes UH (+33253482810, bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the evolution of quadriceps muscle recovery using manual dynamometry in patients under invasive mechanical ventilation in the ICU. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.