ICU Acquired WeaknessSTORMNCT06973746
Effect of the "Sitting Out of Bed in an Arm-chair Position" in ICU on Functional Recovery Among Ventilated Patients
A study testing sitting out of bed in an arm-chair position in people with ICU Acquired Weakness, run by Centre Hospitalier Régional d'Orléans at 11 sites in France.
Trial summary
Chair positioning is one of a series of early mobilization techniques. At present, this technique, which involves moving a patient out of the resuscitation bed, can be performed passively or actively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Acquired Weakness
- What is being tested?
- sitting out of bed in an arm-chair position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesFrance
- Study dates
- 4 Jul 2025to Jan 2028
- Phase
- Interventional
- 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
Who may be able to join
- Patient > 18 years old
- Patient on invasive mechanical ventilation for more than 24 hours
- Patient in recovery phase with a RASS score greater than "-3" for more than 12 hours
- Stay expected to last 48 hours
- Patient has never been placed in a chair during this hospitalization in intensive care.
- Fragility score < 6, during the month preceding admission to intensive care
- Patient (or support person/relative if patient is unable to participate) who has agreed to take part in the study.
Who cannot join
- Patient with an absolute and non-resolving contraindication to chair positioning
- Fracture or orthopedic disorder contraindicating mobilization out of bed
- Obesity with body mass index greater than 45 kg/cm2
- Sacral eschar stage greater than 2
- Patient using a wheelchair for mobility (i.e. paraplegic patient or patient with progressive neurological pathology).
- Patient treated with veno-venous or veno-arterial ECMO at the time of screening.
Show all 18Show fewer
- Moribund patient
- Encephalic death
- Acute polyradiculoneuritis (Guillain-Barré syndrome)
- Myasthenia
- Patient treated by continuous hemodialysis or hemofiltration for more than 72 hours following the onset of awakening.
- Complete transmetatarsal or higher amputation of one or both lower limbs.
- Protected person (under guardianship or curatorship)
- Person under court protection
- Person not affiliated to a social security scheme
- Pregnant or breast-feeding woman
- Patient already included in the study
- Patient taking part in an interventional clinical study, the aim of which is to show an improvement in functional level on discharge from the intensive care unit or which focuses on the theme of early rehabilitation in the intensive care unit.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Hopital Nord Franche Comte
Belfort
Valerie CHAUVIN
Valerie CHAUVIN
- Recruiting
CHU Clermont Ferrand
Clermont-Ferrand
Angelina BARRAGE
Angelina BARRAGE
- Not yet recruiting
CH de DAX
Dax, 40100
Adrien AUVET, Dr
Adrien AUVET, Dr
- Recruiting
CHU de DIJON
Dijon
Jose Arturo PINEDA, Pr
Jose Arturo PINEDA, Pr
- Recruiting
CH Chartres
Le Coudray, 28630
Florence SMIS
Florence SMIS
- Recruiting
Ch Du Mans
Le Mans, 72037
Maie-Hélène LEROYER
Marie-Hélène LEROYER
- Recruiting
CHI Mont de Marsan
Mont-de-Marsan, 40012
Arnaud DELAHAYE, Dr
Arnaud DELAHAYE, Dr
- Recruiting
Centre Hospitalier Universitaire d'Orléans
Orléans, Centre-Val de Loire, 45067
Guillaume FOSSAT
Guillaume Fossat, Pt Msc
- Not yet recruiting
CH de Saint-Lô
Saint-Lô
Edouard GAUQUELIN
Edouard GAUQUELIN
- Not yet recruiting
Hopital Foch
Suresnes
Matthieu REFFIENNA
Matthieu REFFIENNA
- Recruiting
CHRU de TOURS
Tours
Baptiste DARDAINE
Baptiste DARDAINE
About this study
Official title: Effect of the "Sitting Out of Bed in an Arm-chair Position" in ICU on Functional Recovery Among Ventilated Patients: a Prospective Randomized Controlled Trial
Chair positioning is one of a series of early mobilization techniques. At present, this technique, which involves moving a patient out of the resuscitation bed, can be performed passively or actively. It does not constitute a rehabilitative act as such, but it is considered in common paradigms as a technique to improve "the patient's breathing and strength".
However, recommendations issued in 2013 by the Society of intensive care physiotherapy and the society "Société de réanimation de langue française (SRLF)", reveal that this chair position cannot be recommended with a high grade.
Read more
The aim of the investigators is therefore to break down this early mobilization process in intensive care, to find out whether the armchair is an indispensable tool for improving functional and muscular processes.
The research hypothesis is therefore as follows:
"Early armchairing of the resuscitation patient, improves functional recovery compared to a conservative positioning strategy (sitting in bed)."
- Conditions
- ICU Acquired Weakness
- Being tested
- sitting out of bed in an arm-chair position
- Keywords
- mechanical ventilation, ICU Acquired Weakness, Arm Chair, Sitting, Early mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitting out of bed in an arm-chair positionOther
Once the patient has been awake with a RASS score between -1 and +1 for more than 12 hours, he or she must be placed in a chair (by any means) every day for a minimum of 30 minutes until "discharge" from intensive care (or until D28, depending on which comes first), unless there are transient contraindications. If the patient is unable to signal his or her wish to stop the chair session, the criteria for intolerance will be sought and the patient placed in the chair, but in all cases the chair session will not exceed 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| sitting out of bed in an arm-chair position | Experimental | Not described Receives: Other: sitting out of bed in an arm-chair position |
| No chair position | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional level on "discharge" from intensive care
Functional level at "discharge" from the intensive care unit measured by the Physical Function ICU Test scored (PFIT-s).
Minimum value = 0 , meaning worse functionnal status Maximum value = 12, meaning better functionnal status
Measured: On discharge from intensive care or day 28 (depending on which comes first)
Secondary outcomes (7)
ICU Mobility scale
Maximum level of mobility achieved Minimum value = 0, meaning "no mobility" Maximum value = 10, meaning "walking without assistance"
Measured: Day 28
MRC sum score
Presence of muscular weakness acquired in intensive care Minimum value = 0, meaning "no muscular contraction" Maximum value = 60, meaning "normal muscular force"
Measured: Day 28
Length of stay in intensive care unit
Measured: Day 28
Ventilator free days
Number of days without invasive mechanical ventilation
Measured: Day 28
Mortality rate
Measured: Day 28
Total length of hospital stay
Measured: Day 28
Mortality
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start4 Jul 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Acquired WeaknessStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume FOSSAT, Principal investigator, CHU Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973746
- Sponsor's protocol ID
- CHUO-2024-17
- Acronym
- STORM
- Status last verified
- Dec 2025
- First submitted
- 28 Apr 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the "Sitting Out of Bed in an Arm-chair Position" in ICU on Functional Recovery Among Ventilated Patients: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06973746
- Acronym / sponsor ID
- STORM / CHUO-2024-17
- Conditions
- ICU Acquired Weakness
- Keywords
- mechanical ventilation, ICU Acquired Weakness, Arm Chair, Sitting, Early mobility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 May 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.
Chair positioning is one of a series of early mobilization techniques. At present, this technique, which involves moving a patient out of the resuscitation bed, can be performed passively or actively. It does not constitute a rehabilitative act as such, but it is considered in common paradigms as a technique to improve "the patient's breathing and strength".
However, recommendations issued in 2013 by the Society of intensive care physiotherapy and the society "Société de réanimation de langue française (SRLF)", reveal that this chair position cannot be recommended with a high grade.
The aim of the investigators is therefore to break down this early mobilization process in intensive care, to find out whether the armchair is an indispensable tool for improving functional and muscular processes.
The research hypothesis is therefore as follows:
"Early armchairing of the resuscitation patient, improves functional recovery compared to a conservative positioning strategy (sitting in bed)."
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sitting out of bed in an arm-chair position | Experimental | Other: sitting out of bed in an arm-chair position |
| No chair position | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient > 18 years old
- Patient on invasive mechanical ventilation for more than 24 hours
- Patient in recovery phase with a RASS score greater than "-3" for more than 12 hours
- Stay expected to last 48 hours
- Patient has never been placed in a chair during this hospitalization in intensive care.
Key exclusion criteria (18 listed)
- Patient with an absolute and non-resolving contraindication to chair positioning
- Patient using a wheelchair for mobility (i.e. paraplegic patient or patient with progressive neurological pathology).
- Patient treated with veno-venous or veno-arterial ECMO at the time of screening.
- Moribund patient
- Encephalic death
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 |
|---|---|---|
| sitting out of bed in an arm-chair positionOnce the patient has been awake with a RASS score between -1 and +1 for more than 12 hours, he or she must be placed in a chair (by any means) every day for a minimum of 30 minutes until "discharge" from intensive care (or until D28, depending on which comes first), unless there are transient contraindications. If the patient is unable to signal his or her wish to stop the chair session, the criteria for intolerance will be sought and the patient placed in the chair, but in all cases the chair session will not exceed 4 hours. | Other | sitting out of bed in an arm-chair position |
Primary outcome
Functional level on "discharge" from intensive care
Time frame: On discharge from intensive care or day 28 (depending on which comes first)
Functional level at "discharge" from the intensive care unit measured by the Physical Function ICU Test scored (PFIT-s). Minimum value = 0 , meaning worse functionnal status Maximum value = 12, meaning better functionnal status
7 secondary outcomes
ICU Mobility scale
Time frame: Day 28
MRC sum score
Time frame: Day 28
Length of stay in intensive care unit
Time frame: Day 28
Ventilator free days
Time frame: Day 28
Mortality rate
Time frame: Day 28
Total length of hospital stay
Time frame: Day 28
Mortality
Time frame: Month 6
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 19 Dec 2025.
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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.
Guillaume FOSSAT principal investigator
CHU Orléans
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sitting out of bed in an arm-chair position in people with ICU Acquired Weakness, run by Centre Hospitalier Régional d'Orléans at 11 sites 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 7 inclusion and 18 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 Guillaume FOSSAT (+33238651318, guillaume.fossat@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional level on "discharge" from intensive care (time frame: On discharge from intensive care or day 28 (depending on which comes first)). 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 19 Dec 2025.