ICU-acquired Muscle WeaknessPROMOREA1NCT02185989
Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU
A study testing Early electrical stimulation and early leg bicycling added to early standard rehabilitation in people with ICU-acquired Muscle Weakness, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Early mobilization (from the first day if possible), first passive and then passive and active, is recommended for critically ill patients in whom it reduces the duration of mechanical ventilation, the length of hospital stay, improves functional status, muscle strength and quality of life after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU-acquired Muscle Weakness
- What is being tested?
- Early electrical stimulation and early leg bicycling added to early standard rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2014to 24 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- age over 18 yrs
- expected length of stay in the ICU higher than 72 hours
- motor autonomy sufficient for independent ambulation (ass assessed by patient/family/familial practitioner interview
Who cannot join
- Opposition expressed by the patient, his/her legal representative or a member of his/her family
- Pregnant woman
- Resuscitated cardiac arrest before inclusion
- Patient carrying a pacemaker or an implantable defibrillator
- Patient under extracorporeal membrane oxygenation
- Severe acute cerebral disease requiring deep sedation
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- Brain death
- Guillain-Barré syndrome
- Myasthenia gravis
- Known Dementia than can affect the main endpoint assessment
- Deep venous thrombosis or pulmonary embolism treated for less than 48 hours, or floating clot in femoral, iliac of inferior vena cava veins
- Unstable traumatic injuries of the spine
- Severe skin disease or surgical reasons that either prevent performing electrostimulation or bicycling in the next 2 days, or prevent patient's verticalization or transfer to chair in the next 5 days
- Amputation of a lower limb at the trans-metatarsal level or higher
- Inclusion in another interventional study with muscle strength assessment as the primary endpoint
- Moribund patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Rehabilitation Combining Daily Electrical Muscle Stimulation and Early Bedside Cycling Exercise, Compared to Early Standard Rehabilitation. A Randomized, Assessor-blinded, Single-center Study in Intensive Care Patients.
Early mobilization (from the first day if possible), first passive and then passive and active, is recommended for critically ill patients in whom it reduces the duration of mechanical ventilation, the length of hospital stay, improves functional status, muscle strength and quality of life after hospital discharge. The early addition of leg bicycling on a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve muscle strength and further increase the beneficial effects of early mobilization. Electrical muscle stimulation of the quadriceps, is practiced in some intensive care units, and it should, in theory, also through an improvement of muscle strength, increase the beneficial effects of early mobilization.
We hypothesized that early quadriceps electrical stimulation and early work on a cyclo-ergometer associated with a standard protocol of early passive/active mobilization in the ICU may improve muscle function and reduce the duration of mechanical ventilation, length of stay, the number of readmissions and improve the quality of life in the mid term in critically ill patients, as compared to a conventional protocol of early passive/active mobilization.
- Conditions
- ICU-acquired Muscle Weakness
- Being tested
- Early electrical stimulation and early leg bicycling added to early standard rehabilitation
- Keywords
- Critical Illness/*rehabilitation, Humans, *Intensive Care Units, Muscle Weakness/diagnosis/*etiology/physiopathology/prevention & control, Polyneuropathies/diagnosis/*etiology/physiopathology
- Medical subject headings
- Muscle Weakness, Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early electrical stimulation and early leg bicycling added to early standard rehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| Electrical muscle stimulation and bicycling | Active comparator | Patients will undergo early electrical stimulation of the quadriceps and early leg bicycling in addition to routine care (which comprises early standard mobilization) Receives: Other: Early electrical stimulation and early leg bicycling added to early standard rehabilitation |
| Standard early passive/active rehabilitation | No intervention | In this control group, patients will undergo routine care that comprises standard early passive/active rehabilitation delivered by physiotherapist with the assistance of ICU nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global muscle strength assessed by the MRC (Medical research Council, 1978) score
Global muscle strength assessed by the MRC (Medical research Council, 1978) score on the day of ICU discharge (+/- 1 day) in all enrolled patients discharged alive from the ICU. This evaluation will be conducted by a physiotherapist blinded to the randomization group
Measured: on the day of ICU discharge (+/- 1 day)
Secondary outcomes (3)
Changes in thickness of the rectus femoris muscle of each thigh
Changes in thickness of the rectus femoris muscle of each thigh, as measured by ultrasound imaging, between inclusion and ICU discharge (+ / - 1 day).
Measured: from inclusion to ICU discharge (+ / - 1 day)
Frequency of delirium in the ICU.
Delirium is defined by the CAM-ICU scale (Ely CCM 2001 Ely JAMA 2001).
Measured: During ICU stay
Quality of life
Quality of life 6 months after ICU discharge assessed by the SF-36 questionnaire
Measured: 6 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 posted10 Jul 2014 (estimated)
- Study start15 Jul 2014
- Primary completion24 Nov 2016
- Study completion24 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ICU-acquired Muscle 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Boulain, MD, Principal investigator, Centre Hospitalier Régional d'Orléans, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185989
- Sponsor's protocol ID
- CHRO 2014-001
- Other IDs
- ID RCB : 2014-A00566-41
- Acronym
- PROMOREA1
- Status last verified
- Apr 2017
- First submitted
- 4 Jul 2014
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fossat G, Baudin F, Courtes L, Bobet S, Dupont A, Bretagnol A, Benzekri-Lefevre D, Kamel T, Muller G, Bercault N, Barbier F, Runge I, Nay MA, Skarzynski M, Mathonnet A, Boulain T. Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2018 Jul 24;320(4):368-378. doi: 10.1001/jama.2018.9592.
PubMed 30043066
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rehabilitation Combining Daily Electrical Muscle Stimulation and Early Bedside Cycling Exercise, Compared to Early Standard Rehabilitation. A Randomized, Assessor-blinded, Single-center Study in Intensive Care Patients.
- ClinicalTrials.gov ID
- NCT02185989
- Acronym / sponsor ID
- PROMOREA1 / CHRO 2014-001
- Conditions
- ICU-acquired Muscle Weakness
- Keywords
- Critical Illness/*rehabilitation, Humans, *Intensive Care Units, Muscle Weakness/diagnosis/*etiology/physiopathology/prevention & control, Polyneuropathies/diagnosis/*etiology/physiopathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 15 Jul 2014 (actual)
- Primary completion
- 24 Nov 2016 (actual)
- Study completion
- 24 Nov 2016 (actual)
- First posted
- 10 Jul 2014 (estimated)
- 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.
Early mobilization (from the first day if possible), first passive and then passive and active, is recommended for critically ill patients in whom it reduces the duration of mechanical ventilation, the length of hospital stay, improves functional status, muscle strength and quality of life after hospital discharge. The early addition of leg bicycling on a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve muscle strength and further increase the beneficial effects of early mobilization. Electrical muscle stimulation of the quadriceps, is practiced in some intensive care units, and it should, in theory, also through an improvement of muscle strength, increase the beneficial effects of early mobilization.
We hypothesized that early quadriceps electrical stimulation and early work on a cyclo-ergometer associated with a standard protocol of early passive/active mobilization in the ICU may improve muscle function and reduce the duration of mechanical ventilation, length of stay, the number of readmissions and improve the quality of life in the mid term in critically ill patients, as compared to a conventional protocol of early passive/active mobilization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical muscle stimulation and bicycling | Active comparator | Other: Early electrical stimulation and early leg bicycling added to early standard rehabilitationPatients will undergo early electrical stimulation of the quadriceps and early leg bicycling in addition to routine care (which comprises early standard mobilization) |
| Standard early passive/active rehabilitation | No intervention | –In this control group, patients will undergo routine care that comprises standard early passive/active rehabilitation delivered by physiotherapist with the assistance of ICU nurses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 18 yrs
- expected length of stay in the ICU higher than 72 hours
- motor autonomy sufficient for independent ambulation (ass assessed by patient/family/familial practitioner interview
Key exclusion criteria (16 listed)
- Opposition expressed by the patient, his/her legal representative or a member of his/her family
- Pregnant woman
- Resuscitated cardiac arrest before inclusion
- Patient carrying a pacemaker or an implantable defibrillator
- Patient under extracorporeal membrane oxygenation
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 electrical stimulation and early leg bicycling added to early standard rehabilitation | Other | Electrical muscle stimulation and bicycling |
Primary outcome
Global muscle strength assessed by the MRC (Medical research Council, 1978) score
Time frame: on the day of ICU discharge (+/- 1 day)
Global muscle strength assessed by the MRC (Medical research Council, 1978) score on the day of ICU discharge (+/- 1 day) in all enrolled patients discharged alive from the ICU. This evaluation will be conducted by a physiotherapist blinded to the randomization group
3 secondary outcomes
Changes in thickness of the rectus femoris muscle of each thigh
Time frame: from inclusion to ICU discharge (+ / - 1 day)
Frequency of delirium in the ICU.
Time frame: During ICU stay
Quality of life
Time frame: 6 months after ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Derived from this study: PubMed 30043066Fossat G, Baudin F, Courtes L, Bobet S, Dupont A, Bretagnol A, Benzekri-Lefevre D, Kamel T, Muller G, Bercault N, Barbier F, Runge I, Nay MA, Skarzynski M, Mathonnet A, Boulain T. Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2018 Jul 24;320(4):368-378. doi: 10.1001/jama.2018.9592.
Related trials for ICU-acquired Muscle Weakness
Recruiting
Blood Flow Restriction Training for Mechanically Ventilated Patients With ICU-Acquired Weakness
Intensive Care Unit Acquired Weakness
Not yet recruiting
Beyond Voluntary Effort: Reliability and Validity of Magnetic Femoral Nerve Stimulation for Assessing Quadriceps Strength in Critically Ill Patient
Critical Illness, ICU-acquired Weakness
RecruitingObservational study
Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation
Intensive Care Unit Acquired Weakness, Muscle Weakness
Recruiting
MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients
Sepsis, Critical Illness
Active, not recruiting
Assessing The Effects of Exercise, Protein, and Electric Stimulation On Intensive Care Unit Patients Outcomes
Muscle Weakness, Critical Illness
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. This study is not recruiting at the moment.
Thierry Boulain, MD principal investigator
Centre Hospitalier Régional d'Orléans, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early electrical stimulation and early leg bicycling added to early standard rehabilitation in people with ICU-acquired Muscle Weakness, run by Centre Hospitalier Régional d'Orléans 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 3 inclusion and 16 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: finished, as of the sponsor's last update on 13 Apr 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global muscle strength assessed by the MRC (Medical research Council, 1978) score (time frame: on the day of ICU discharge (+/- 1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02185989, which also lists 1 linked publication.
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 13 Apr 2017.